Meta-Analysis
doi: 10.1002/14651858.CD013534.pub2.
Skin care interventions in infants for preventing eczema and food allergy
Affiliations
- PMID: 33545739
- PMCID: PMC8094581
- DOI: 10.1002/14651858.CD013534.pub2
Item in Clipboard
Meta-Analysis
Skin care interventions in infants for preventing eczema and food allergy
Cochrane Database Syst Rev.
.
Update in
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Skin care interventions in infants for preventing eczema and food allergy.Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD013534. doi: 10.1002/14651858.CD013534.pub3. Cochrane Database Syst Rev. 2022. PMID: 36373988 Free PMC article.
Abstract
Background: Eczema and food allergy are common health conditions that usually begin in early childhood and often occur together in the same people. They can be associated with an impaired skin barrier in early infancy. It is unclear whether trying to prevent or reverse an impaired skin barrier soon after birth is effective in preventing eczema or food allergy.
Objectives: Primary objective To assess effects of skin care interventions, such as emollients, for primary prevention of eczema and food allergy in infants Secondary objective To identify features of study populations such as age, hereditary risk, and adherence to interventions that are associated with the greatest treatment benefit or harm for both eczema and food allergy.
Search methods: We searched the following databases up to July 2020: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, and Embase. We searched two trials registers and checked reference lists of included studies and relevant systematic reviews for further references to relevant randomised controlled trials (RCTs). We contacted field experts to identify planned trials and to seek information about unpublished or incomplete trials.
Selection criteria: RCTs of skin care interventions that could potentially enhance skin barrier function, reduce dryness, or reduce subclinical inflammation in healthy term (> 37 weeks) infants (0 to 12 months) without pre-existing diagnosis of eczema, food allergy, or other skin condition were included. Comparison was standard care in the locality or no treatment. Types of skin care interventions included moisturisers/emollients; bathing products; advice regarding reducing soap exposure and bathing frequency; and use of water softeners. No minimum follow-up was required.
Data collection and analysis: This is a prospective individual participant data (IPD) meta-analysis. We used standard Cochrane methodological procedures, and primary analyses used the IPD dataset. Primary outcomes were cumulative incidence of eczema and cumulative incidence of immunoglobulin (Ig)E-mediated food allergy by one to three years, both measured by the closest available time point to two years. Secondary outcomes included adverse events during the intervention period; eczema severity (clinician-assessed); parent report of eczema severity; time to onset of eczema; parent report of immediate food allergy; and allergic sensitisation to food or inhalant allergen.
Main results: This review identified 33 RCTs, comprising 25,827 participants. A total of 17 studies, randomising 5823 participants, reported information on one or more outcomes specified in this review. Eleven studies randomising 5217 participants, with 10 of these studies providing IPD, were included in one or more meta-analysis (range 2 to 9 studies per individual meta-analysis). Most studies were conducted at children's hospitals. All interventions were compared against no skin care intervention or local standard care. Of the 17 studies that reported our outcomes, 13 assessed emollients. Twenty-five studies, including all those contributing data to meta-analyses, randomised newborns up to age three weeks to receive a skin care intervention or standard infant skin care. Eight of the 11 studies contributing to meta-analyses recruited infants at high risk of developing eczema or food allergy, although definition of high risk varied between studies. Durations of intervention and follow-up ranged from 24 hours to two years. We assessed most of this review's evidence as low certainty or had some concerns of risk of bias. A rating of some concerns was most often due to lack of blinding of outcome assessors or significant missing data, which could have impacted outcome measurement but was judged unlikely to have done so. Evidence for the primary food allergy outcome was rated as high risk of bias due to inclusion of only one trial where findings varied when different assumptions were made about missing data. Skin care interventions during infancy probably do not change risk of eczema by one to two years of age (risk ratio (RR) 1.03, 95% confidence interval (CI) 0.81 to 1.31; moderate-certainty evidence; 3075 participants, 7 trials) nor time to onset of eczema (hazard ratio 0.86, 95% CI 0.65 to 1.14; moderate-certainty evidence; 3349 participants, 9 trials). It is unclear whether skin care interventions during infancy change risk of IgE-mediated food allergy by one to two years of age (RR 2.53, 95% CI 0.99 to 6.47; 996 participants, 1 trial) or allergic sensitisation to a food allergen at age one to two years (RR 0.86, 95% CI 0.28 to 2.69; 1055 participants, 2 trials) due to very low-certainty evidence for these outcomes. Skin care interventions during infancy may slightly increase risk of parent report of immediate reaction to a common food allergen at two years (RR 1.27, 95% CI 1.00 to 1.61; low-certainty evidence; 1171 participants, 1 trial). However, this was only seen for cow's milk, and may be unreliable due to significant over-reporting of cow's milk allergy in infants. Skin care interventions during infancy probably increase risk of skin infection over the intervention period (RR 1.34, 95% CI 1.02 to 1.77; moderate-certainty evidence; 2728 participants, 6 trials) and may increase risk of infant slippage over the intervention period (RR 1.42, 95% CI 0.67 to 2.99; low-certainty evidence; 2538 participants, 4 trials) or stinging/allergic reactions to moisturisers (RR 2.24, 95% 0.67 to 7.43; low-certainty evidence; 343 participants, 4 trials), although confidence intervals for slippages and stinging/allergic reactions are wide and include the possibility of no effect or reduced risk. Preplanned subgroup analyses show that effects of interventions were not influenced by age, duration of intervention, hereditary risk, FLG mutation, or classification of intervention type for risk of developing eczema. We could not evaluate these effects on risk of food allergy. Evidence was insufficient to show whether adherence to interventions influenced the relationship between skin care interventions and risk of developing eczema or food allergy.
Authors' conclusions: Skin care interventions such as emollients during the first year of life in healthy infants are probably not effective for preventing eczema, and probably increase risk of skin infection. Effects of skin care interventions on risk of food allergy are uncertain. Further work is needed to understand whether different approaches to infant skin care might promote or prevent eczema and to evaluate effects on food allergy based on robust outcome assessments.
Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
My institution received a grant from L'Oreal (La Roche Possay) for ‘An investigation of the skin barrier restoring effects of a cream containing ceramides in a multi vesicular emulsion in people with dry, eczema‐prone, skin (RESTORE)’ (clinical trial).
My institution received a grant from Johnson & Johnson for ‘A randomised controlled trial of a specially designed wash product and lotion for the maintenance of healthy skin and mind in babies (BOND)’.
My institution and I personally received payment for study design and steering, for travel to meetings for study or other purposes, and for participation in review activities (such as data monitoring boards, statistical analysis, end point committees) from Hyphens Pharma, L'Oreal (La Roche Possay), and Johnson & Johnson.
I received personal payment for consultancy, travel/accommodations/meeting expenses unrelated to activities pre‐mentioned, and lectures from Regeneron in collaboration with Sanofi Genzyme with regard to biologic drug trials for atopic eczema; Pfizer with regard to biologic and topical drug trials for atopic eczema; and Galapagos and Kymab with regard to biologic drug trials for atopic eczema.
My institution received grants/grants pending from Regeneron in collaboration with Sanofi Genzyme with regard to biologic drug trials for atopic eczema; Pfizer with regard to biologic and topical drug trials for atopic eczema; and Galapagos and Kymab with regard to biologic drug trials for atopic eczema.
My institution and I personally received payment for review preparation from Regeneron in collaboration with Sanofi Genzyme with regard to biologic drug trials for atopic eczema; Pfizer with regard to biologic and topical drug trials for atopic eczema; and Galapagos and Kymab with regard to Biologic drug trials for atopic eczema.
My institution received payment for development of educational presentations from Regeneron in collaboration with Sanofi Genzyme with regard to biologic drug trials for atopic eczema.
I am or have been an Investigator and Consultant for the following organisations: Astellas, Boots, Dermavant, Galapagos, Galderma, Hyphens, Johnson & Johnson, Kymab, LEO Pharma, L’Oreal, Menlo, Novartis, Oxagen, Pfizer, Procter & Gamble, Reckitt Benckiser, Regeneron, and Sanofi Genzyme.
Reports an NIHR RfPB grant awarded to Nottingham University Hospitals Trust. My employing institution, Imperial College London, has a formal research and innovation partnership with Nestle. This partnership does not directly involve me, and I do not think it is relevant to this review, but Nestle do have skin care products and products for prevention or treatment of allergic conditions within their portfolio.
Figures
Study flow diagram.
Trial sequential analysis for eczema (RR of 30%).
Trial sequential analysis for eczema (RR of 20%).
Trial sequential analysis for food allergy (RR of 30%).
Trial sequential analysis for food allergy (RR of 20%).
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 1: Eczema by 1‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 2: Sensitivity analysis: Eczema by 1‐3 years including aggregate trial data
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 3: Sensitivity analysis: Eczema by 1‐3 years (UKWP only)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 4: Sensitivity analysis: Eczema by 1‐3 years (including data from all 4 arms of PreventADALL)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 5: Sensitivity analysis: Eczema by 1‐3 years ‐ low risk of bias
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 6: Sensitivity analysis: Eczema by 1‐3 years ‐ excluding non‐prospectively acquired data
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 7: Sensitivity analysis: Eczema by 6 months‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 8: Sensitivity analysis: Eczema after the intervention period (at 1 year or beyond ‐ up to 2 years)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 9: Subgroup analysis (study level): Eczema by 1‐3 years by intervention type
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 10: Subgroup analysis (study level): Eczema by 1‐3 years by prescribed intervention duration
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 11: Subgroup analysis (study level): Eczema by 1‐3 years, by prescribed intervention timing
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 12: Participant level treatment interaction: Eczema by 1‐3 years for treatment initiation < 4 days versus ≥ 4 days of age
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 13: Participant level treatment interaction: Eczema by 6 months‐3 years for treatment initiation < 4 days versus ≥ 4 days of age
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 14: Participant level treatment interaction: Eczema by 1‐3 years by FLG genotype (0 mutations versus 1/2 mutations)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 15: Participant level treatment interaction: Eczema by 6months‐3 years by FLG genotype (0 mutations versus 1/2 mutations)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 16: Participant level treatment interaction: Eczema by 1‐3 years by ≥ 1 first degree relative with history of allergic disease
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 17: CACE: Eczema by 1‐3 years for use over intervention period ≥ 3 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 18: CACE Sensitivity: Eczema by 1‐3 years for use over intervention period ≥ 5 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 19: CACE Sensitivity: Eczema by 1‐3 years for use over intervention period 7 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 20: CACE Sensitivity: Eczema by 1‐3 years for use over first 3 months ≥ 3 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 21: CACE Sensitivity: Eczema by 1‐3 years for use over first 3 months ≥ 5 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 22: CACE Sensitivity: Eczema by 1‐3 years for use over first 3 months 7 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 23: Sensitivity analysis: Eczema by 1‐3 years for studies included in CACE for use over intervention period ≥ 3 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 24: Sensitivity analysis: Eczema by 1‐3 years for studies included in CACE for use over intervention period ≥ 5 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 25: Sensitivity analysis: Eczema by 1‐3 years for studies included in CACE for use over intervention period 7 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 26: Sensitivity analysis: Eczema by 1‐3 years for studies included in CACE for use over first 3 months ≥ 3 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 27: Sensitivity analysis: Eczema by 1‐3 years for studies included in CACE for use over first 3 months ≥ 5 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 28: Sensitivity analysis: Eczema by 1‐3 years for studies included in CACE for use over first 3 months 7 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 29: Food allergy by 1‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 30: Sensitivity analysis: Food allergy by 1‐3 years (diagnosed by oral food challenge or investigator assessment)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 31: Sensitivity analysis: Food allergy by 1‐3 years (parent report of doctor diagnosis)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 32: CACE: Food allergy by 1‐3 years for use over intervention period ≥ 3 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 33: CACE Sensitivity: Food allergy by 1‐3 years for use over intervention period ≥ 5 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 34: CACE Sensitivity: Food allergy by 1‐3 years for use over intervention period 7 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 35: CACE Sensitivity: Food allergy by 1‐3 years for use over first 3 months ≥ 3 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 36: CACE Sensitivity: Food allergy by 1‐3 years for use over first 3 months ≥ 5 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 37: CACE Sensitivity: Food allergy by 1‐3 years for use over first 3 months 7 days a week
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 38: Adverse event: skin infection
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 39: Adverse event: stinging or allergic reaction to moisturisers
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 40: Adverse event: slippage accidents
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 41: Serious Adverse Events
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 42: Clinician‐assessed eczema severity at 1‐3 years (clear/mild versus moderate/severe/very severe)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 43: Clinician‐assessed eczema severity at 1‐3 years (standardised mean difference)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 44: Parent‐reported eczema severity at 1‐3 years (clear/mild versus moderate/severe/very severe)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 45: Parent‐reported eczema severity at 1‐3 years (mean difference)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 46: Time to onset of eczema
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 47: Subgroup analysis: Time to onset of eczema (< 1 year follow‐up versus ≥ 1 year follow‐up)
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 48: Parent report of immediate (< 2 hours) reaction to a known common food allergen
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 49: Parent report of immediate (< 2 hours) reaction to milk
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 50: Parent report of immediate (< 2 hours) reaction to egg
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 51: Parent report of immediate (< 2 hours) reaction to peanut
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 52: Allergic sensitisation to common foods or inhalants at 1‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 53: Allergic sensitisation to common foods at 1‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 54: Allergic sensitisation to milk at 1‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 55: Allergic sensitisation to egg at 1‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 56: Allergic sensitisation to peanut at 1‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 57: Allergic sensitisation to inhalants at 1‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 58: Sensitivity analysis: Allergic sensitisation to common foods at 6 months‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 59: Sensitivity analysis: Allergic sensitisation to milk at 6 months‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 60: Sensitivity analysis: Allergic sensitisation to egg at 6 months‐3 years
Comparison 1: Skin care intervention versus standard skin care or no skin care intervention, Outcome 61: Sensitivity analysis: Allergic sensitisation to peanut at 6 months‐3 years
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References
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Lowe 2018a {published and unpublished data}
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- ACTRN12609000727246. Prevention of eczema by a barrier lipid equilibrium strategy (PEBBLES) pilot study - Testing the compliance and safety of a strategy for improving infant skin function. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12609000727246 (first received 19 August 2009).
-
- ACTRN12613000472774. The PEBBLES study: Prevention of Eczema By a Barrier Lipid Equilibrium Strategy. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364115 (first received 23 April 2013).
-
- ACTRN12617001380381. The PEBBLES study – testing a strategy for preventing eczema and food allergy in high risk infants. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373506 (first received 20 September 2017).
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- Lowe A, Su J, Allen K Abramson M, Cranswick N, Robertson C, et al. A randomized trial of a barrier lipid replacement strategy for the prevention of atopic dermatitis and allergic sensitization: the pebbles pilot study NCD. Pediatric Dermatology 2017;34(S1):S35-6. [DOI: 10.1111/pde.13195] - DOI - PubMed
Lund 2020 {published data only}
McClanahan 2019 {published and unpublished data}
-
- McClanahan D, Wong A, Kezic S, Samrao A, Hajar T, Hill E, et al. A randomized controlled trial of an emollient with ceramide and filaggrin-associated amino acids for the primary prevention of atopic dermatitis in high-risk infants. Journal of the European Academy of Dermatology & Venereology 2019;33(11):2807-94. [DOI: 10.1111/jdv.15786] - DOI - PubMed
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- NCT01375205. Comparing Cetaphil Restoraderm System versus standard skin care in infants. clinicaltrials.gov/ct2/show/NCT01375205 (first received 17 June 2011).
Migacheva 2018 {published data only}
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- Migacheva N, Zhestkov A. Combined approach to primary prevention of atopic dermatitis. Allergy 2018;73:331. [DOI: 10.1111/all.13537] - DOI
NCT03376243 {unpublished data only}
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- NCT03376243. EARLYEMOLLIENT - Feasibility of early emollient use in children with atopic eczema. clinicaltrials.gov/ct2/show/NCT03376243 (first received 18 December 2017).
Raisi Dehkordi 2010 {published data only}
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- IRCT201102265912N1. The effect of massage with sunflower oil and sesame oil. www.who.int/trialsearch/Trial2.aspx?TrialID=IRCT201102265912N1 (first received 8 January 2012).
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- Raisi Dehkordi Z. A comparative study of the effect of massage with sunflower oil or sesame oil on infants' crying and sleep times: a randomized control trial. European Psychiatry 2014;29(Suppl 1):1. [DOI: 10.1016/S0924-9338(14)78247-1] - DOI
Rush 1986 {published data only}
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- Rush J. Does routine newborn bathing reduce Staphylococcus aureus colonization rates? A randomized controlled trial. Birth 1986;13(3):176‐80. - PubMed
Sankaranarayanan 2005 {published data only}
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- Sankaranarayanan K, Mondkar JA, Chauhan MM, Mascarenhas BM, Mainkar AR, Salvi RY. Oil massage in neonates: an open randomized controlled study of coconut versus mineral oil. Indian Pediatrics 2005;42(9):877‐84. [PMID: ] - PubMed
Simpson 2014 {published and unpublished data}
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- Chalmers JR, Simpson EL, Chen YY, Cork MJ, Brown SJ, Thomas KS, et al. Feasibility study of barrier enhancement for eczema prevention (BEEP). British Journal of Dermatology 2014;170:e8-e9. [DOI: 10.1186/ISRCTN84854178] - DOI
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- Glatz M, Polley EC, Schmid-Grendelmeier P, Simpson EL, Kong HH. Emollient therapy alters barrier function and skin microbes in infants at risk for developing atopic dermatitis. Swiss Medical Weekly 2017;147(Suppl 228):53S.
Skjerven 2020 {published and unpublished data}
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- Skjerven HO, Rehbinder EM, Vettukattil R, LeBlanc M, Granum B, Haugen G, et al. Department of Error: Skin emollient and early complementary feeding to prevent infant atopic dermatitis (PreventADALL): a factorial, multicentre, cluster-randomised trial (The Lancet (2020) 395(10228) (951-61) (S0140673619329836)). Lancet 2020;395(10228):e53. [DOI: 10.1016/S0140-6736(20)30422-0] - DOI - PubMed
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- Skjerven HO, Rehbinder EM, Vettukattil R, LeBlanc M, Granum B, Haugen G, et al. Skin emollient and early complementary feeding to prevent infant atopic dermatitis (PreventADALL): a factorial, multicentre, cluster-randomised trial. Lancet 2020;395(10228):951‐961. [DOI: 10.1016/S0140-6736(19)32983-6] - DOI - PubMed
Thitthiwong 2019 {published data only}
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- Koopitakkajorn T, Thitthiwong P. The good skin care practices and emollient using since early infancy as the primary prevention of infantile atopic dermatitis in infants at risk: a randomized controlled trial. Pediatric Dermatology 2017;34(S1):S35. [DOI: 10.1111/pde.13195] - DOI
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- TCTR20161208001. The good skin care practices and emollient using since early infancy as the primary prevention of infantile atopic dermatitis in infants at risk: a randomized controlled trial. apps.who.int/trialsearch/Trial2.aspx?TrialID=TCTR20161208001 (first received 4 December 2016).
Tielsch 2007 {published data only}
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- NCT00109616. Community trial of newborn skin and umbilical cord cleansing on neonatal mortality in Nepal. clinicaltrials.gov/ct2/show/NCT00109616 (first received 2 May 2005).
Yonezawa 2018 {published and unpublished data}
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- JPRN-UMIN000013260. Effects of moisturizing skin care from the neonatal stage for improving skin barrier function and preventing skin trouble. www.who.int/trialsearch/Trial2.aspx?TrialID=JPRN-UMIN000013260 (first received 1 March 2014).
References to studies excluded from this review
ACTRN12607000466448 {published data only}
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- ACTRN12607000466448. An intervention to reduce the prevalence and impact of asthma and food allergies occurring in association with atopic dermatitis through improved skin care in infants and young children. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=82278 (first received 11 September 2007).
Ahmed 2007 {published data only}
Alonso 2013 {published data only}
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- ISRCTN00356649. Efficacy of petroleum jelly in the prevention of irritant diaper dermatitis. www.isrctn.com/ISRCTN00356649 (first received 8 October 2010).
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CTRI201709009890 {published data only}
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- CTRI/2017/09/009890. Comparing the effect of three different skin antiseptic preparations in neonates (first 28 days of life) - randomized trial. ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19272 (first received 22 September 2017).
Da Cunha 2005 {published data only}
Da Cunha 2005a {published data only}
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- Da Cunha ML, Procianoy RS. Skin microflora and bathing of preterm newborn infants. In: Pediatric Academic Societies Annual Meeting. Washington, DC, 2005.
Darmstadt 2004 {published data only}
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- Darmstadt GL, Badrawi N, Law PA, Ahmed S, Bashir M, Iskander I, et al. Topically applied sunflower seed oil prevents invasive bacterial infections in preterm infants in Egypt: a randomized, controlled clinical trial. Pediatric Infectious Disease Journal 2004;23(8):719-25. [DOI: 10.1097/01.inf.0000133047.50836.6f] - DOI - PubMed
Darmstadt 2005 {published data only}
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- Darmstadt GL, Saha SK, Nawshad Uddin Ahmed ASM, Azad Chowdhury MAK, Law PA, Ahmed S, et al. Skin barrier-enhancing emollients prevent nosocomial infections in preterm infants in Bangladesh. In: Pediatric Academic Societies Annual Meeting. Washington DC, 2005.
Darmstadt 2005a {published data only}
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- Darmstadt GL, Saha SK, Ahmed AS, Chowdhury MA, Law PA, Ahmed S, et al. Effect of topical treatment with skin barrier-enhancing emollients on nosocomial infections in preterm infants in Bangladesh: a randomised controlled trial. Lancet 2005;365(9464):1039‐45. [DOI: 10.1016/S0140-6736(05)71140-5] - DOI - PubMed
Darmstadt 2007 {published data only}
Darmstadt 2008 {published data only}
Darmstadt 2014 {published data only}
Duggan 2015 {published data only}
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Erdemir 2015 {published data only}
Ernest 1995 {published data only}
EUCTR2005‐001269‐32‐AT {published data only}
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- EUCTR2005-001269-32-AT. Clinical trial on skin care in neonatology. A comparison between two skin care products and no skin care. www.clinicaltrialsregister.eu/ctr-search/search?query=2005-001269-32 (first received 22 November 2005).
Fernandez 2018 {published data only}
Field 2008 {published data only}
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- Field T, Field T, Cullen C, Largie S, Diego M, Schanberg S, et al. Lavender bath oil reduces stress and crying and enhances sleep in very young infants. Early Human Development 2008;84(6):399‐401. - PubMed
Fluhr 2012 {published data only}
Foisy 2011 {published data only}
Franck 2000 {published data only}
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- Franck LS, Quinn D, Zahr L. Effect of less frequent bathing of preterm infants on skin flora and pathogen colonization. Journal of Obstetric, Gynecologic, and Neonatal Nursing 2000;29(6):584‐9. - PubMed
Friscia 2019 {published data only (unpublished sought but not used)}
Gao 2008 {published data only}
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- Gao Y. Effectiveness observation on moisturizer for infant eczema. Chinese Journal of Leprosy and Skin Disease 2008;24(4):294.
Garcia Bartels 2009 {published data only}
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- Garcia Bartels N, Mleczko A, Schink T, Proquitte H, Wauer RR, Blume-Peytavi U. Influence of bathing or washing on skin barrier function in newborns during the first four weeks of life. Skin Pharmacology & Physiology 2009;22(5):248-57. - PubMed
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Gfatter 1997 {published data only}
Gleiss 1965 {published data only}
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- Gleiss J, Sommerkamp B. Comparative study of soapless skin cleansing of infants. Archiv fur Kinderheilkunde 1965;172(2):154-60. - PubMed
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- Gunt HB, Levy SB, Lutrario CA. A natural cream-to-powder formulation developed for the prevention of diaper dermatitis in diaper-wearing infants and children: barrier property and in-use tolerance studies. Journal of Drugs in Dermatology 2018;17(5):566‐70. - PubMed
Hauk 2008 {published data only}
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- Hauk PJ. The role of food allergy in atopic dermatitis. Current Allergy and Asthma Reports 2008;8(3):188-94. - PubMed
Hawkins 2017 {published data only}
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- Hawkins S, Edmunds M, Foy V, Vincent C, Cox E, O'Shea S, et al. Superior skin care for infants with a new nourishing regimen containing stearic acid, petrolatum, and fatty acids: tip-to-toe-wash and lotion. Pediatric Dermatology 2017;34(S1):S34. [DOI: 10.1111/pde.13195] - DOI
Hnatko 1977 {published data only}
Horimukai 2016 {published data only}
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- Horimukai K, Morita K, Narita M, Kondo M, Kabashima S, Inoue E, et al. Transepidermal water loss measurement during infancy can predict the subsequent development of atopic dermatitis regardless of filaggrin mutations. Allergology International 2016;65(1):103-8. - PubMed
Hu 2014 {published data only}
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IRCT201306164617N {published data only}
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- IRCT201306164617N. Effect of bath on clinical outcomes in preterm infants: a randomized controlled trial. www.who.int/trialsearch/Trial2.aspx?TrialID=IRCT201306164617N7 (first received 28 June 2013).
IRCT201306164617N7 {published data only}
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- IRCT201306164617N7. Effect of bath on clinical outcomes in preterm infants: a randomized controlled trial. en.irct.ir/trial/4950 (first received 28 June 2013).
IRCT2013090814594N1 {published data only}
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- IRCT2013090814594N1. A comparison between the effects of swaddled bathing and conventional bathing on physiological and behavioral parameters among the preterm neonates. en.irct.ir/trial/14191 (first received 3 January 2014).
IRCT2016111530903N {published data only}
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- IRCT2016111530903N. The efficacy of Chamomile oil on infantile colic. www.who.int/trialsearch/Trial2.aspx?TrialID=IRCT2016111530903N1 (first received 4 April 2017).
IRCT20170911036118N1 {published data only}
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- IRCT20170911036118N1. Effect of massage and washing in physiological jaundice. en.irct.ir/trial/27093 (first received 17 January 2018).
ISRCTN71423189 {published data only}
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- ISRCTN71423189. Multi-centre randomised controlled trial of ion-exchange water softeners for the treatment of atopic eczema in children (Softened Water Eczema Trial). www.isrctn.com/ISRCTN71423189 (first received 8 January 2007). [DOI: 10.1186/ISRCTN71423189] - DOI
ISRCTN89579779 {published data only}
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- ISRCTN89579779. The use of Aquaphor to prevent transepidermal water loss and to maintain electrolyte balance in preterm newborn infants in the first week of life. www.isrctn.com/ISRCTN89579779 (first received 30 September 2004). [DOI: 10.1186/ISRCTN89579779] - DOI
Jabraeile 2016 {published data only}
Jensen 1971 {published data only}
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- Jensen JP. Transcutaneous absorption of boron from a baby ointment used prophylactically against diaper dermatitis. Nordisk Medicin 1971;86(48):1425‐9. - PubMed
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- JPRN-UMIN000005158. Randomized controlled trial to evaluate clinical efficacy of once- or twice-daily skincare with emollient for prevention of atopic dermatitis exacerbation. upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005803 (first received 3 July 2011).
JPRN‐UMIN000018110 {published data only}
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- JPRN-UMIN000018110. Preliminary study on the skin cleaning method without cleaning agent during bathing in the NICU - Comparison with the case of using a skin cleaning agent. www.who.int/trialsearch/Trial2.aspx?TrialID=JPRN-UMIN000018110 (first received 26 June 2015).
JPRN‐UMIN000025302 {published data only}
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- JPRN-UMIN000025302. Open test of skin care products for newborns. www.who.int/trialsearch/Trial2.aspx?TrialID=JPRN-UMIN000025302 (first received 16 November 2017).
JPRN UMIN000032181 {published data only}
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- JPRN-UMIN000032181. Study of neonates on the intestinal bacterial flora and skin conditions. upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036709 (first received 10 April 2018).
JPRN UMIN000032798 {published data only}
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- JPRN-UMIN000032798. Baby diaper study (No.2016-001). upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037416 (first received 31 May 2018).
JPRN UMIN000035357 {published data only}
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- JPRN-UMIN000035357. Effect of moisturizer application on perianal area in neonates; comparison of effects on erythema and skin barrier function at 1-month checkup. upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040287 (first received 25 December 2018).
JPRN UMIN000035412 {published data only}
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- JPRN-UMIN000035412. Effect of change in bathing and skin care in infancy on the incidence of eczema at 6 months of age. rctportal.niph.go.jp/en/detail?trial_id=UMIN000035412 (first received 7 January 2019).
Kadar 1974 {published data only}
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- Kadar V, Osbourn R. The mildness of soaps in the care of infants' skin: a comparative study. Current Therapeutic Research - Clinical and Experimental 1974;16(5):452-6. [PMID: ] - PubMed
Kanti 2014 {published data only}
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- Kanti V, Grande C, Stroux A, Buhrer C, Blume-Peytavi U, Garcia Bartels N. Influence of sunflower seed oil on the skin barrier function of preterm infants: a randomized controlled trial. Dermatology 2014;229(3):230-9. - PubMed
Kanti 2017 {published data only}
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- Kanti V, Gunther M, Stroux A, Sawatzky S, Henrich W, Abou-Dakn M, et al. Influence of sunflower seed oil or baby lotion on the skin barrier function of newborns: a pilot study. Journal of Cosmetic Dermatology 2017;16(4):500-7. - PubMed
Kiechl Kohlendorfer 2008 {published data only}
Konar 2019 {published data only}
Koplin 2019 {published data only}
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- Kottner J, Kanti V, Dobos G, Hahnel E, Lichterfeld-Kottner A, Richter C, et al. The effectiveness of using a bath oil to reduce signs of dry skin: a randomized controlled pragmatic study. International Journal of Nursing Studies 2017;65:17-24. - PubMed
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Lane 1993 {published data only}
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Leung 2015 {published data only}
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- Leung DYM. Prophylactic emollient use beginning at birth prevents atopic dermatitis. Journal of Pediatrics 2015;166(3):777-8. - PubMed
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- Ling L, Bi XY. Swimming and bathing with Chinese herbal medicine in treatment of neonatal jaundice: clinical analysis of 50 cases. Journal of Qilu Nursing 2011;17(1):42‐3.
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- Linnamaa P, Savolainen J, Koulu L, Tuomasjukka S, Kallio H, Yang B, et al. Blackcurrant seed oil for prevention of atopic dermatitis in newborns: a randomized, double-blind, placebo-controlled trial. Clinical and Experimental Allergy 2010;40(8):1247‐55. [DOI: 10.1111/j.1365-2222.2010.03540.x] - DOI - PubMed
Lowe 2012 {published data only}
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Nangia 2015 {published data only}
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- NCT00162747. Topical therapy for prevention of infections in preterm infants. clinicaltrials.gov/ct2/show/NCT00162747 (first received 13 September 2005).
NCT00257569 {published data only}
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- NCT00257569. Study of atopic dermatitis in pediatrics. clinicaltrials.gov/ct2/show/NCT00257569 (first received 23 November 2005).
NCT00806221 {published data only}
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- NCT00806221. An open-label study investigating the effects of early skin barrier protection on the development of atopic dermatitis. clinicaltrials.gov/ct2/show/NCT00806221 (first received 10 December 2008).
NCT00917085 {published data only}
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- NCT00917085. Is skin-to-skin care helpful for preterm infants and their mothers after birth? clinicaltrials.gov/ct2/show/NCT00917085 (first received 10 June 2009).
NCT01131403 {published data only}
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- NCT01131403. Clinical analysis of the influence of using the skin care products on the diaper area in comparison with using a cotton wool cloth, moistened with clear water on the skin physiology of the newborns from the 1st day to the 4th week of life. https://clinicaltrials.gov/ct2/show/NCT01131403 (first received 27 May 2010).
NCT01177111 {published data only}
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- NCT01177111. Impact of sunflower seed oil massage on neonatal mortality and morbidity in Nepal. clinicaltrials.gov/show/NCT01177111 (first received 6 August 2010).
NCT01364948 {published data only}
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- NCT01364948. Effect of coconut oil application in reducing water loss from skin of premature babies in first week of life (TEWL) (TopOilTewl). clinicaltrials.gov/ct2/show/NCT01364948 (first received 3 June 2011).
NCT01396642 {published data only}
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- NCT01396642. Topical emollient therapy. clinicaltrials.gov/ct2/show/NCT01396642 (first received 19 July 2011).
NCT01758068 {published data only}
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- NCT01758068. Effect of twice daily application of coconut oil in reducing water loss from skin of premature babies in first week of life. clinicaltrials.gov/ct2/show/NCT01758068 (first received 31 December 2012).
NCT02120833 {published data only}
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- NCT02120833. A test to determine the usefulness and safety of a cream used on babies with dry itchy skin. www.clinicaltrials.gov/ct2/show/NCT02120833 (first received 7 September 2015).
NCT02403999 {published data only}
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- NCT02403999. A tolerability assessment study of three wash products in infants. clinicaltrials.gov/ct2/show/NCT02403999 (first received 31 March 2015).
NCT02404493 {published data only}
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- NCT02404493. Test to determine the effectiveness of moisturizing balm used on babies with dry, itchy skin. clinicaltrials.gov/ct2/show/NCT02404493 (first received 31 March 2015).
NCT02557698 {published data only}
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- NCT02557698. Effectiveness of using an oil bath additive. clinicaltrials.gov/ct2/show/NCT02557698 (first received 23 September 2015).
NCT02614248 {published data only}
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- NCT02614248. The use of coconut oil for the prevention and treatment of diaper dermatitis in the NICU population. clinicaltrials.gov/ct2/show/NCT02614248 (first received 25 November 2015).
NCT02857062 {published data only}
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- To evaluate the in use tolerance of E45 eczema repair emollient in babies and children with (very(dry/atopic skin. clinicaltrials.gov/ct2/show/NCT02857062 (first received 5 August 2016).
NCT03089476 {published data only}
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- NCT03089476. Evaluating skin barrier dysfunction in infants at high risk of atopy. clinicaltrials.gov/ct2/show/NCT03089476 (first received 24 March 2017).
NCT03112876 {published data only}
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- NCT03112876. Sebum collection and skin barrier function analysis (Sebum). clinicaltrials.gov/ct2/show/NCT03112876 (first received 13 April 2017).
NCT03143504 {published data only}
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- NCT03143504. A longitudinal investigation of skin barrier development from birth and the validation of early predictors of atopic eczema risk: the Skin Testing for Atopic eczema Risk (STAR) Study (STAR). clinicaltrials.gov/ct2/show/NCT03143504 (first received 8 May 2017).
NCT03719742 {published data only}
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- NCT03719742. A clinical study to evaluate the safety and efficacy of a baby cleanser and a moisturizer. clinicaltrials.gov/ct2/show/NCT03719742 (first received 25 October 2018).
NCT03738163 {published data only}
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NCT03742414 {published data only}
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NCT03813472 {published data only}
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- NCT03813472. Hydration sensor for atopic dermatitis. clinicaltrials.gov/ct2/show/results/NCT03813472 (first received 23 January 2019).
NCT04001855 {published data only}
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- NCT04001855. Evaluating the effect of bathing additives in atopic dermatitis. clinicaltrials.gov/ct2/show/NCT04001855 (first received 28 June 2019).
NCT04099602 {published data only}
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Nesmiyanov 2018 {published data only}
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References to studies awaiting assessment
ISRCTN38965585 {published data only}
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- CTRI/2014/12/005282. Can an intervention involving improvements in community-based newborn massage practice with promotion of cold-pressed sunflower oil as preferred emollient improve newborn survival in rural North India? www.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2014/12/005282 (first received 11 December 2014).
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NCT04398758 {unpublished data only}
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