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Meta-Analysis
. 2024 Feb 13;2(2):CD005495.
doi: 10.1002/14651858.CD005495.pub5.

Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants

Jane Orton  1   2 , Lex W Doyle  3 , Tanya Tripathi  2 , Roslyn Boyd  4 , Peter J Anderson  5   6 , Alicia Spittle  2   7
Affiliations
Meta-Analysis

Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants

Jane Orton et al. Cochrane Database Syst Rev. .

Abstract

Background: Infants born preterm are at increased risk of cognitive and motor impairments compared with infants born at term. Early developmental interventions for preterm infants are targeted at the infant or the parent-infant relationship, or both, and may focus on different aspects of early development. They aim to improve developmental outcomes for these infants, but the long-term benefits remain unclear. This is an update of a Cochrane review first published in 2007 and updated in 2012 and 2015.

Objectives: Primary objective To assess the effect of early developmental interventions compared with standard care in prevention of motor or cognitive impairment for preterm infants in infancy (zero to < three years), preschool age (three to < five years), and school age (five to < 18 years). Secondary objective To assess the effect of early developmental interventions compared with standard care on motor or cognitive impairment for subgroups of preterm infants, including groups based on gestational age, birthweight, brain injury, timing or focus of intervention and study quality.

Search methods: We searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO and trial registries in July 2023. We cross-referenced relevant literature, including identified trials and existing review articles.

Selection criteria: Studies included randomised, quasi-randomised controlled trials (RCTs) or cluster-randomised trials of early developmental intervention programmes that began within the first 12 months of life for infants born before 37 weeks' gestational age (GA). Interventions could commence as an inpatient but had to include a post discharge component for inclusion in this review. Outcome measures were not prespecified, other than that they had to assess cognitive outcomes, motor outcomes or both. The control groups in the studies could receive standard care that would normally be provided.

Data collection and analysis: Data were extracted from the included studies regarding study and participant characteristics, timing and focus of interventions and cognitive and motor outcomes. Meta-analysis using RevMan was carried out to determine the effects of early developmental interventions at each age range: infancy (zero to < three years), preschool age (three to < five years) and school age (five to < 18 years) on cognitive and motor outcomes. Subgroup analyses focused on GA, birthweight, brain injury, time of commencement of the intervention, focus of the intervention and study quality. We used standard methodological procedures expected by Cochrane to collect data and evaluate bias. We used the GRADE approach to assess the certainty of evidence.

Main results: Forty-four studies met the inclusion criteria (5051 randomly assigned participants). There were 19 new studies identified in this update (600 participants) and a further 17 studies awaiting outcomes. Three previously included studies had new data. There was variability in the focus and intensity of the interventions, participant characteristics, and length of follow-up. All included studies were either single or multicentre trials and the number of participants varied from fewer than 20 to up to 915 in one study. The trials included in this review were mainly undertaken in middle- or high-income countries. The majority of studies commenced in the hospital, with fewer commencing once the infant was home. The focus of the intervention programmes for new included studies was increasingly targeted at both the infant and the parent-infant relationship. The intensity and dosages of interventions varied between studies, which is important when considering the applicability of any programme in a clinical setting. Meta-analysis demonstrated that early developmental intervention may improve cognitive outcomes in infancy (developmental quotient (DQ): standardised mean difference (SMD) 0.27 standard deviations (SDs), 95% confidence interval (CI) 0.15 to 0.40; P < 0.001; 25 studies; 3132 participants, low-certainty evidence), and improves cognitive outcomes at preschool age (intelligence quotient (IQ); SMD 0.39 SD, 95% CI 0.29 to 0.50; P < 0.001; 9 studies; 1524 participants, high-certainty evidence). However, early developmental intervention may not improve cognitive outcomes at school age (IQ: SMD 0.16 SD, 95% CI -0.06 to 0.38; P = 0.15; 6 studies; 1453 participants, low-certainty evidence). Heterogeneity between studies for cognitive outcomes in infancy and preschool age was moderate and at school age was substantial. Regarding motor function, meta-analysis of 23 studies showed that early developmental interventions may improve motor outcomes in infancy (motor scale DQ: SMD 0.12 SD, 95% CI 0.04 to 0.19; P = 0.003; 23 studies; 2737 participants, low-certainty evidence). At preschool age, the intervention probably did not improve motor outcomes (motor scale: SMD 0.08 SD, 95% CI -0.16 to 0.32; P = 0.53; 3 studies; 264 participants, moderate-certainty evidence). The evidence at school age for both continuous (motor scale: SMD -0.06 SD, 95% CI -0.31 to 0.18; P = 0.61; three studies; 265 participants, low-certainty evidence) and dichotomous outcome measures (low score on Movement Assessment Battery for Children (ABC) : RR 1.04, 95% CI 0.82 to 1.32; P = 0.74; 3 studies; 413 participants, low-certainty evidence) suggests that intervention may not improve motor outcome. The main source of bias was performance bias, where there was a lack of blinding of participants and personnel, which was unavoidable in this type of intervention study. Other biases in some studies included attrition bias where the outcome data were incomplete, and inadequate allocation concealment or selection bias. The GRADE assessment identified a lower certainty of evidence in the cognitive and motor outcomes at school age. Cognitive outcomes at preschool age demonstrated a high certainty due to more consistency and a larger treatment effect.

Authors' conclusions: Early developmental intervention programmes for preterm infants probably improve cognitive and motor outcomes during infancy (low-certainty evidence) while, at preschool age, intervention is shown to improve cognitive outcomes (high-certainty evidence). Considerable heterogeneity exists between studies due to variations in aspects of the intervention programmes, the population and outcome measures utilised. Further research is needed to determine which types of early developmental interventions are most effective in improving cognitive and motor outcomes, and in particular to discern whether there is a longer-term benefit from these programmes.

Trial registration: ClinicalTrials.gov NCT01089296.

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Conflict of interest statement

AS: Is an author on three trials included in this review (Finlayson 2020; Spittle 2009; Treyvaud 2022) and works as a health professional (Physiotherapist at the Royal Women's Hospital, Melbourne, Australia). She received a grant from the National Health and Medical Research Council of Australia. She has also published opinions in medical journals on topics related to this review.

RB: Is an author on two trials included in this review (Colditz 2019; Spittle 2009).

JO: Is an author on one trial included in this review (Spittle 2009); works as a health professional (Physiotherapist at the Royal Women's Hospital, Melbourne, Australia). She has also published opinions in medical journals on topics related to this review.

PJA: Is an author on two trials included in this review (Spittle 2009; Treyvaud 2022). He has received funding as an independent contractor/consultant for Pearson Australia and Pearson Clinical Assessment. He received a grant from the National Health and Medical Research Council of Australia. He has also published opinions in medical journals on topics related to this review.

LWD: Is an author on two trials included in this review (Spittle 2009; Treyvaud 2022). He received a grant from the National Health and Medical Research Council of Australia. He has also published opinions in medical journals on topics related to this review.

TT: Is an author on one trial included in this review (Dusing 2018).

None of the authors of the included studies were involved in determining the overall study inclusion and exclusion criteria; and did not make study eligibility decisions about, extract data from, carry out the risk of bias assessment for, or perform GRADE assessments for those studies. TT extracted the data and checked interpretation for Spittle 2009. AS and JO extracted data and checked interpretation for Dusing 2015. TT and JO extracted data and checked interpretation for Finlayson 2020.

Figures

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Screen4Me 2021
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Screen4Me 2023
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Funnel plot for cognitive outcomes in infancy
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Funnel plot cognitive outcome at preschool age
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Funnel plot cognitive outcome at school age
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Funnel plot motor outcome in infancy
1.1
1.1. Analysis
Comparison 1: Early developmental intervention versus standard follow‐up (all studies), Outcome 1: Cognitive outcome in infancy ‐ Developmental Quotient
1.2
1.2. Analysis
Comparison 1: Early developmental intervention versus standard follow‐up (all studies), Outcome 2: Cognitive outcome at preschool age ‐ Intelligence Quotient
1.3
1.3. Analysis
Comparison 1: Early developmental intervention versus standard follow‐up (all studies), Outcome 3: Cognitive outcome at school age ‐ Intelligence Quotient
1.4
1.4. Analysis
Comparison 1: Early developmental intervention versus standard follow‐up (all studies), Outcome 4: Motor outcome in infancy ‐ Developmental Quotient
1.5
1.5. Analysis
Comparison 1: Early developmental intervention versus standard follow‐up (all studies), Outcome 5: Motor outcome at preschool age
1.6
1.6. Analysis
Comparison 1: Early developmental intervention versus standard follow‐up (all studies), Outcome 6: Motor outcome at school age
1.7
1.7. Analysis
Comparison 1: Early developmental intervention versus standard follow‐up (all studies), Outcome 7: Motor outcome at school age
1.8
1.8. Analysis
Comparison 1: Early developmental intervention versus standard follow‐up (all studies), Outcome 8: Rate of cerebral palsy
2.1
2.1. Analysis
Comparison 2: Early developmental intervention versus standard follow‐up (subgroup analysis: gestational age), Outcome 1: Cognitive outcome in infancy ‐ Developmental Quotient
2.2
2.2. Analysis
Comparison 2: Early developmental intervention versus standard follow‐up (subgroup analysis: gestational age), Outcome 2: Rate of cerebral palsy
3.1
3.1. Analysis
Comparison 3: Early developmental intervention versus standard follow‐up (subgroup analysis: birth weight), Outcome 1: Cognitive outcome in infancy ‐ Developmental Quotient
3.2
3.2. Analysis
Comparison 3: Early developmental intervention versus standard follow‐up (subgroup analysis: birth weight), Outcome 2: Cognitive outcome at preschool age ‐ Intelligence Quotient
4.1
4.1. Analysis
Comparison 4: Early developmental intervention versus standard follow‐up (subgroup analysis: brain injury), Outcome 1: Cognitive outcome in infancy ‐ Developmental Quotient
4.2
4.2. Analysis
Comparison 4: Early developmental intervention versus standard follow‐up (subgroup analysis: brain injury), Outcome 2: Motor outcome in infancy ‐ Developmental Quotient
5.1
5.1. Analysis
Comparison 5: Early developmental intervention versus standard follow‐up (subgroup analysis: commencement of intervention), Outcome 1: Cognitive outcome in infancy ‐ Developmental Quotient
5.2
5.2. Analysis
Comparison 5: Early developmental intervention versus standard follow‐up (subgroup analysis: commencement of intervention), Outcome 2: Cognitive outcome at preschool age ‐ Intelligence Quotient
5.3
5.3. Analysis
Comparison 5: Early developmental intervention versus standard follow‐up (subgroup analysis: commencement of intervention), Outcome 3: Cognitive outcome at school age ‐ Intelligence Quotient
5.4
5.4. Analysis
Comparison 5: Early developmental intervention versus standard follow‐up (subgroup analysis: commencement of intervention), Outcome 4: Motor outcome in infancy ‐ Developmental Quotient
5.5
5.5. Analysis
Comparison 5: Early developmental intervention versus standard follow‐up (subgroup analysis: commencement of intervention), Outcome 5: Motor outcome at preschool age
5.6
5.6. Analysis
Comparison 5: Early developmental intervention versus standard follow‐up (subgroup analysis: commencement of intervention), Outcome 6: Motor outcome at school age
5.7
5.7. Analysis
Comparison 5: Early developmental intervention versus standard follow‐up (subgroup analysis: commencement of intervention), Outcome 7: Motor outcome at school age (low score on MABC)
5.8
5.8. Analysis
Comparison 5: Early developmental intervention versus standard follow‐up (subgroup analysis: commencement of intervention), Outcome 8: Rate of cerebral palsy
6.1
6.1. Analysis
Comparison 6: Early developmental intervention versus standard follow‐up (subgroup analysis: focus of intervention), Outcome 1: Cognitive outcome in infancy ‐ Developmental Quotient
6.2
6.2. Analysis
Comparison 6: Early developmental intervention versus standard follow‐up (subgroup analysis: focus of intervention), Outcome 2: Cognitive outcome at preschool age ‐ Intelligence Quotient
6.3
6.3. Analysis
Comparison 6: Early developmental intervention versus standard follow‐up (subgroup analysis: focus of intervention), Outcome 3: Cognitive outcome at school age ‐ Intelligence Quotient
6.4
6.4. Analysis
Comparison 6: Early developmental intervention versus standard follow‐up (subgroup analysis: focus of intervention), Outcome 4: Motor outcome in infancy
6.5
6.5. Analysis
Comparison 6: Early developmental intervention versus standard follow‐up (subgroup analysis: focus of intervention), Outcome 5: Motor outcome at preschool age
6.6
6.6. Analysis
Comparison 6: Early developmental intervention versus standard follow‐up (subgroup analysis: focus of intervention), Outcome 6: Motor outcome at school age
6.7
6.7. Analysis
Comparison 6: Early developmental intervention versus standard follow‐up (subgroup analysis: focus of intervention), Outcome 7: Motor outcome at school age (low score on MABC)
6.8
6.8. Analysis
Comparison 6: Early developmental intervention versus standard follow‐up (subgroup analysis: focus of intervention), Outcome 8: Rate of cerebral palsy
7.1
7.1. Analysis
Comparison 7: Early developmental intervention versus standard follow‐up (sensitivity analysis: risk of bias), Outcome 1: Cognitive outcome in infancy ‐ Developmental Quotient
7.2
7.2. Analysis
Comparison 7: Early developmental intervention versus standard follow‐up (sensitivity analysis: risk of bias), Outcome 2: Cognitive outcome at preschool age ‐ Intelligence Quotient
7.3
7.3. Analysis
Comparison 7: Early developmental intervention versus standard follow‐up (sensitivity analysis: risk of bias), Outcome 3: Cognitive outcome at school age ‐ Intelligence Quotient
7.4
7.4. Analysis
Comparison 7: Early developmental intervention versus standard follow‐up (sensitivity analysis: risk of bias), Outcome 4: Motor outcome in infancy ‐ Developmental Quotient
7.5
7.5. Analysis
Comparison 7: Early developmental intervention versus standard follow‐up (sensitivity analysis: risk of bias), Outcome 5: Motor outcome at preschool age
7.6
7.6. Analysis
Comparison 7: Early developmental intervention versus standard follow‐up (sensitivity analysis: risk of bias), Outcome 6: Motor outcome at school age
7.7
7.7. Analysis
Comparison 7: Early developmental intervention versus standard follow‐up (sensitivity analysis: risk of bias), Outcome 7: Motor outcome at school age (low score on MABC)
7.8
7.8. Analysis
Comparison 7: Early developmental intervention versus standard follow‐up (sensitivity analysis: risk of bias), Outcome 8: Rate of cerebral palsy
See this image and copyright information in PMC

Update of

References

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    1. Ohgi S, Fukuda M, Akiyama T, Gima H. Effect of an early intervention programme on low birthweight infants with cerebral injuries. Journal of Paediatrics and Child Health 2004;40(12):689-95. [PMID: ] - PubMed
Pascoali Rodovanski 2021 {published data only}
    1. Pascoali Rodovanski G, Bez Reus BA, Cechinel Damiani AV, Franco Mattos K, Moreira RS, Neves Dos Santos A. Home-based early stimulation program targeting visual and motor functions for preterm infants with delayed tracking: feasibility of a randomized clinical trial. Research in Developmental Disabilities 2021;116:104037. [DOI: 10.1016/j.ridd.2021.104037] [PMID: ] - DOI - PubMed
Resnick 1988 {published data only}
    1. Resnick MB, Armstrong S, Carter RL. Developmental intervention program for high-risk premature infants: effects on development and parent infant interactions. Journal of Developmental and Behavioral Pediatrics 1988;9(2):73-8. [PMID: ] - PubMed
Rice 1979 {published data only}
    1. Rice RD. The effects of the Rice infants sensorimotor stimulation treatment on the development of high-risk infants. Birth Defects Original Article Series 1979;15(7):7-26. [PMID: ] - PubMed
Sajaniemi 2001 {published data only}
    1. Sajaniemi N, Makela J, Salokorpi T, Wendt L, Hamalainen T, Hakamies-Blomqvist L. Cognitive performance and attachment patterns at four years of age in extremely low birth weight infants after early intervention. European Child & Adolescent Psychiatry 2001;10(2):122-9. [PMID: ] - PubMed
    1. Salokorpi T, Rauito T, Kajantie E, Wednt L. Is early occupational therapy in extremely preterm infants of benefit in the long run? Pediatric Rehabilitation 2002;5(2):91-8. [PMID: ] - PubMed
    1. Salokorpi T, Sajaniemi N, Rajantie I, Hallback H, Hamalainen T, Rita H, et al. Neurodevelopment until the adjusted age of 2 years in extremely low birth weight infants after early intervention - a case-control study. Pediatric Rehabilitation 1998;2(4):157-63. [PMID: ] - PubMed
Sgandurra 2017 {published data only}
    1. Sgandurra G, Bartalena L, Giovanni C, Greisen G, Herskind A, Inguaggiato E, et al. Home-based, early intervention with mechatronic toys for preterm infants at risk of neurodevelopmental disorders (CARETOY): a RCT protocol. BMC Pediatrics 2014;14:268. [PMID: ] - PMC - PubMed
    1. Sgandurra G, Lorentzen J, Inguaggiato E, Bartalena L, Beani E, Cecchi et al. A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the ’CareToy System’. PLoS One 2017;12(3):e1073521. [DOI: 10.1371/journal.pone.0173521] [PMID: ] - DOI - PMC - PubMed
Shafaroodi 2022 {published data only}
    1. Shafaroodi N, Askary Kachoosangy R, Heidarzadeh M, Qorbani M, Shojaei S H, Beheshti SZ. Promoting developmental outcomes of premature infants by creating opportunities for parent empowerment (COPE). Iranian Rehabilitation Journal 2022;20(1):11-7. [CINAHL: 161431021] [DOI: 10.32598/irj.20.1.125.4] - DOI
Spittle 2009 {published data only}
    1. Spencer-Smith MM, Spittle AJ, Doyle LW, Lee KJ, Lorefice L, Suetin A, et al. Long-term benefits of home-based preventive care for preterm infants: a randomized trial. Pediatrics 2012;130(6):1094-101. [PMID: ] - PubMed
    1. Spittle AJ, Anderson PJ, Lee KJ, Ferretti C, Eeles A, Orton J, et al. Preventive care at home for very preterm infants improves infant and caregiver outcomes at 2 years. Pediatrics 2010;126(1):e171-8. [PMID: ] - PubMed
    1. Spittle AJ, Barton S, Treyvaud K, Molloy CS, Doyle LW, Anderson PJ. School-age outcomes of early intervention for preterm infants and their parents: a randomized trial. Pediatrics 2016;138(6):e20161363. [PMID: ] - PubMed
    1. Spittle AJ, Ferretti C, Anderson PJ, Orton J, Eeles A, Bates L, et al. Improving the outcome of infants born at <30 weeks gestation - a randomized controlled trial of preventative care at home. BMC Pediatrics 2009;9(73):no pagination. [PMID: ] - PMC - PubMed
    1. Spittle AJ, Treyvaud K, Lee KJ, Anderson PJ, Doyle LW. The role of social risk in an early preventative care programme for infants born very preterm: a randomized controlled trial. Developmental Medicine and Child Neurology 2018;60(1):54-62. [PMID: ] - PubMed
Teti 2009 {published data only}
    1. Teti DM, Black M, Viscardi R, Glass P, O'Connell, Baker L, et al. Intervention with African American premature infants: four-month results of an early intervention program. Journal of Early Intervention 2009;31(2):146-66. [CINAHL: 105501262] [DOI: 10.1177/1053815109331864] - DOI
Treyvaud 2022 {published data only}
    1. Treyvaud K, Eeles AL, Spittle AJ, Lee KJ, Cheong JL, Shah P, et al. Preterm infant outcomes at 24 months after clinician-supported web-based intervention. Journal of Pediatrics 2022;150(4):e2021055398. [DOI: 10.1542/peds.2021-055398] [PMID: ] - DOI - PubMed
Wu 2014 {published data only}
    1. Wu YC, Leng CH, Hsieh WS, Hsu CH, Chen WJ, Gau SS, et al. A randomized controlled trial of clinic-based and home-based interventions in comparison with usual care for preterm infants: effects and mediators. Research in Developmental Disabilities 2014;35(10):2384-93. [PMID: ] - PubMed
Yigit 2002 {published data only}
    1. Yigit S, Kerem M, Livanelioglu A, Oran O, Erdem G, Mutlu A, et al. Early physiotherapy intervention in premature infants. Turkish Journal of Pediatrics 2002;44(3):224-9. [PMID: ] - PubMed
Youn 2021 {published data only}
    1. Youn YA, Shin SH, Kim EK, Jin HJ, Jung YH, Heo JS, et al. Preventive intervention program on the outcomes of very preterm infants and caregivers: a multicenter randomized controlled trial. Brain Science 2021;11(5):575. [DOI: 10.3390/brainsci11050575] [PMID: ] - DOI - PMC - PubMed
Zhang 2023 {published data only}
    1. Zhang J, Cao M, Yue S, Yan J, Shang Y. Exploring effect of postdischarge developmental support program on preterm infant neurodevelopment and BDNF gene DNA methylation. Advances in Neonatal Care 2023;23(2):E50-8. [DOI: 10.1097/ANC.0000000000001046] [PMID: ] - DOI - PubMed
Ziegler 2021 {published data only}
    1. Ziegler SA, Rhein S, Meichtry M, Wirz A, Hielkema T, Hadders-Algra M, Swiss Neonatal Network and Follow-Up Group. The Coping with and Caring for Infants with Special Needs intervention was associated with improved motor development in preterm infants. Acta Paediatrica 2021;110(4):1189-1200. [PMID: ] - PMC - PubMed

References to studies excluded from this review

Adiguzel 2023 {published data only}
    1. Adiguzel H, Sarikabadayi YU, Elbasan B. Investigation of the effectiveness of family collaborative physiotherapy programs applied to high-risk infants. Physiotherapy Theory and Practice 2023;39(9):1871-87. [PMID: ] - PubMed
Badr 2006 {published data only}
    1. Badr LK, Garg M, Kamath MK. Intervention for infants with brain injury: results of a randomized controlled study. Infant Behaviour & Development 2006;29(1):80-90. - PMC - PubMed
Barbu‐Roth 2022 {published data only}
    1. Barbu-Roth M, Dumuids MV, Forma V, Anderson DI, Provasi J, Biran V. Effects of early crawling training on the motor development of very premature infants. Developmental Medicine and Child Neurology 2022;64(S3):37.
Beckwith 1988 {published data only}
    1. Beckwith L. Intervention with disadvantaged parents of sick preterm infants. Psychiatry 1988;51(3):242-7. - PubMed
Beeghly 1995 {published data only}
    1. Beeghly M, Brazelton TB, Flannery KA, Nugent JK, Barrett DE, Tronick EZ. Specificity of preventative pediatric intervention effects in early infancy. Journal Developmental and Behavioural Pediatrics 1995;16(3):158-66. - PubMed
Benzies 2017 {published data only}
    1. Benzies KM, Shah V, Aziz K, Isaranuwatchai W, Palacio-Derflingher L, Scotland J, et al. Family Integrated Care (FICare) in level II neonatal intensive care units: study protocol for a cluster randomized controlled trial. Trials 2017;18(1):467. - PMC - PubMed
Britain 1995 {published data only}
    1. Britain LA, Holmes GE, Hassanein RS. High-risk children referred to an early-intervention developmental program. Clinical Pediatrics 1995;34(12):635-41. - PubMed
Chen 2001 {published data only}
    1. Chen D, Zhang J, Chen Y. Early intervention on intelligent development of premature infant. Chinese Mental Health Journal 2001;15:55-7.
Culp 1989 {published data only}
    1. Culp RE, Culp AM, Harmon RJ. A tool for educating parents about their premature infants. Birth 1989;16(1):23-6. - PubMed
Dumuids‐Vernet 2023 {published data only}
    1. Dumuids-Vernet M V, Forma V, Provasi J, Anderson DI, Hinnekens E, Soyez E, et al. Stimulating the motor development of very premature infants: effects of early crawling training on a mini-skateboard. Frontiers in Pediatrics 2023;11:1198016. [DOI: 10.3389/fped.2023.1198016] [PMID: ] - DOI - PMC - PubMed
Fjortoft 2017 {published data only}
    1. Fjørtoft T, Ustad T, Follestad T, Kaaresen PI, Øberg GK. Does a parent-administrated early motor intervention influence general movements and movement character at 3 months of age in infants born preterm? Early Human Development 2017;112:20-24. - PubMed
Flierman 2016 {published data only}
    1. Flierman M, Koldewijn K, Meijssen D, Wassenaer-Leemhuis A, Aarnoudse-Moens C, Schie P, et al. Feasibility of a preventive parenting intervention for very preterm children at 18 months corrected age: a randomized pilot trial.. The Journal of Pediatrics 2016;176:79-85. - PubMed
Fucile 2012 {published data only}
    1. Fucile S, McFarland DH, Gisel EG, Lau C. Oral and nonoral sensorimotor interventions facilitate suck-swallow-respiration functions and their coordination in preterm infants. Early Human Development 2012;88(6):345-50. - PMC - PubMed
Ghetti 2019 {published data only}
    1. Ghetti C, Bieleninik Ł, Hysing M, Kvestad I, Assmus J, Romeo R, et al. Longitudinal study of music therapy's effectiveness for premature infants and their caregivers (LongSTEP): protocol for an international randomised trial. BMJ Open 2019;9(8):e025062. - PMC - PubMed
Girolami 1994 {published data only}
    1. Girolami JL, Campbell SK. Efficacy of a neuro-developmental treatment program to improve motor control in infants born prematurely. Pediatric Physical Therapy 1994;6:175-84.
Guimarães 2015 {published data only}
    1. Guimarães EL, Tudella E. Immediate effect of training at the onset of reaching in preterm infants:randomized clinical trial. Journal of Motor Behavior 2015;47(6):535-549. - PubMed
Guzzetta 2011 {published data only}
    1. Guzzetta A, D'Acunto MG, Carotenuto M, Berardi N, Bancale A, Biagioni E, et al. The effects of preterm infant massage on brain electrical activity. Developmental Medicine and Child Neurology 2011;53(Suppl 4):46-51. - PubMed
Hane 2015 {published data only}
    1. Hane AA, Myers MM, Hofer, MA, Ludwig RJ, Halperin MS, Austin J, et al. Family nurture intervention improves the quality of maternal caregiving in the neonatal intensive care unit: evidence from a randomized controlled trial. Journal of Developmental and Behavioral Pediatrics. 2015;36(3):188-96. - PubMed
Hielkema 2010 {published data only}
    1. Hielkema T, Blauw-Hospers CH, Dirks T, Drijver-Messelink M, Bos AF, Hadders-Algra M. Does physiotherapeutic intervention affect motor outcome in high-risk infants? An approach combining a randomized controlled trial and process evaluation. Developmental Medicine and Child Neurology 2011;53(3):e8-15. - PubMed
    1. Hielkema T, Hamer EG, Boxum AG, La Bastide-Van Gemert S, Dirks T, Reinders-Messelink HA, et al. LEARN2MOVE 0-2 years, a randomized early intervention trial for infants at very high risk of cerebral palsy: neuromotor, cognitive, and behavioral outcome. Disability Rehabilitation 2020;42(26):3752-3761. - PubMed
    1. Hielkema T, Hamer EG, Boxum AG, La Bastide-Van Gemert S, Maathuis CGB, Reinders-Messelink HA, et al. LEARN 2 MOVE 0-2 years: Outcome of a randomized controlled trial on early intervention in infants at very high risk for cerebral palsy including process analysis. Developmental Medicine and Child Neurology 2017;59(S2):38.
    1. Hielkema T, Hamer EG, Reinders-Messelink HA, Maathuis CG, Bos AF, Dirks T, et al. LEARN 2 MOVE 0-2 years: effects of a new intervention program in infants at very high risk for cerebral palsy; a randomized controlled trial. BMC Pediatrics 2010;10:76. - PMC - PubMed
Jeba 2022 {published data only}
    1. Jeba A, Suganthirababu P, Sosale S, Alagesan J, Srinivasan V, Sebastian N. Neurodevelopmental outcome of very preterm and moderate to late preterm babies at the corrected age of first year. European journal of molecular and clinical medicine 2022;9(8):280-290.
Kaaresen 2006b {published data only}
    1. Kaaresen PI, Rønning JA, Ulvund SE, Dahl LB. A randomized, controlled trial of the effectiveness of an early-intervention program in reducing parenting stress after preterm birth. Pediatrics 2006;118(1):e9-19. - PubMed
    1. Olafsen KS, Rønning JA, Handegård BH, Ulvund SE, Dahl LB, Kaaresen PI. Regulatory competence and social communication in term and preterm infants at 12 months corrected age. Results from a randomized controlled trial. Infant Behavior and Development 2012;35(1):140-9. [PMID: ] - PubMed
Kachoosangy 2020 {published data only}
    1. Askary Kachoosangy R, Shafaroodi N, Heidarzadeh M, Qorbani M, Bordbbr A, Hejazi Shirmard M, et al. Increasing mothers' confidence and ability by Creating Opportunities for Parent Empowerment (COPE): a randomized, controlled trial. Iran Journal of Child Neurology 2020;14(1):77-83. - PMC - PubMed
Kanda 2004 {published data only}
    1. Kanda T, Pidcock FS, Hayakawa K, Yamori Y, Shikata Y. Motor outcome differences between two groups of children with spastic diplegia who received different intensities of early onset physiotherapy followed for 5 years. Brain and Development 2004;26(2):118-26. - PubMed
Kang 1995 {published data only}
    1. Kang R, Barnard K, Hammond M, Oshio S, Spencer C, Thibodeaux B, et al. Preterm infant follow-up project: a multi-site field experiment of hospital and home intervention programs for mothers and preterm infants. Public Health Nursing 1995;12(3):171-80. - PubMed
Kendrick 2000 {published data only}
    1. Kendrick D, Elkan R, Hewitt M, Dewey M, Blair M, Robinson J, et al. Does home visiting improve parenting and the quality of the home environment? A systematic review and meta analysis. Archives of Disease in Childhood 2000;82(6):443-51. - PMC - PubMed
Kiechl‐Kohlendoefer 2015 {published data only}
    1. Kiechl-Kohlendorfer U, Merkle U, Deufert D, Neubauer V, Peglow UP, Griesmaier E. Effect of developmental care for very premature infants on neurodevelopmental outcome at 2 years of age. Infant Behavioral Development 2015;39:166-72. - PubMed
Kleberg 2000 {published data only}
    1. Kleberg A, Westrup B, Stjernqvist K. Developmental outcome, child behavior and mother-child interaction at 3 years of age following Newborn Individualized Developmental Care and Intervention Program (NIDCAP) intervention. Early Human Development 2000;60(2):123-35. - PubMed
Kleberg 2002 {published data only}
    1. Kleberg A, Westrup B, Stjernqvist K, Lagercrantz H. Indications of improved cognitive development at one year of age among infants born very prematurely who received care based on the Newborn Individualized Developmental Care and Assessment Program (NIDCAP). Early Human Development 2002;68(2):83-91. - PubMed
Lai 2016 {published data only}
    1. Lai MM, D'Acunto G, Guzzetta A, Boyd RN, Rose SE, Fripp J, et al. PREMM: preterm early massage by the mother: protocol of a randomised controlled trial of massage therapy in very preterm infants. BMC Pediatrics 2016;16(1):146. - PMC - PubMed
Landsem 2014 {published data only}
    1. Landsem IP, Handegard BH, Tunby J, Ulvund SE, Ronning JA. Early intervention program reduces stress in parents of preterms during childhood, a randomized controlled trial. Trials 2014;15:387. - PMC - PubMed
    1. Landsem IP, Handegård BH, Ulvund SE, Kaaresen PI, Rønning JA. Early intervention influences positively quality of life as reported by prematurely born children at age nine and their parents; a randomized clinical trial. Health Quality Life Outcomes Feb 2015;feb:13-25. - PMC - PubMed
Leyener 2021 {published data only}
    1. Leyener. Promotion of motor development and movement quality in preterm infants through the early application of "Movement Imitation Therapy for Preterm Babies (MIT-PB)" in the first three months of life. International Clinical Trials Registry Platform 2021. [ICTRP MAIN ID DRKS00022899: DRKS00022899]
Liu 2015 {published data only}
    1. Liu FC, Hsieh WS, Hsu CH, Lin YJ, Chen WJ, Lin CH, et al. Effectiveness of a family-centered intervention program in very low birth weight preterm infants at term age: a randomized controlled trial. Physiotherapy 2015;101:401-403.
Ma 2015 {published data only}
    1. Ma L, Yang B, Meng L, Wang B, Zheng C, Cao A. Effect of early intervention on premature infants' general movements.. Brain Development 2015;37(4):387-393. - PubMed
Matsuishi 1998 {published data only}
    1. Matsuishi T, Ishibashi S, Kamiya Y, Shoju J, Yamashita Y, Fukuda S, et al. Early intervention for very-low-birth-weight infants. Brain and Development 1998;20(1):18-21. - PubMed
McCarton 2006 {published data only}
    1. McCarton C. Behavioral outcomes in low birth weight infants. Pediatrics 1998;102(5 Supp E):1293-7. - PubMed
Meijssen 2010 {published data only}
    1. Meijssen D, Wolf MJ, Koldewijn K, Houtzager BA, Wassenaer A, Tronick E, et al. The effect of the Infant Behavioral Assessment and Intervention Program on mother-infant interaction after very preterm birth. Journal of Child Psychology and Psychiatry and Allied Disciplines 2010;51(11):1287-1295. - PubMed
    1. Meijssen D, Wolf MJ, Bakel H, Koldewijn K, Kok J, Baar A. Maternal attachment representations after very preterm birth and the effect of early intervention. Infant Behavior and Development 2011;34(1):72-80. - PubMed
    1. Meijssen DE, Wolf MJ, Koldewijn K, Wassenaer AG, Kok JH, Baar AL. Parenting stress in mothers after very preterm birth and the effect of the Infant Behavioural Assessment and Intervention Program. Child: Care, Health and Development 2011;37(2):195-202. - PubMed
Nair 2009 {published data only}
    1. Nair MK, Philip E, Jeyaseelan L, George B, Mathews S, Padma K. Effect of Child Development Centre model early stimulation among at risk babies: a randomized controlled trial. Indian Pediatrics 2009;46(Suppl):S20-6. - PubMed
Nascimento 2019 {published data only}
    1. Nascimento AL, Toledo AM, Merey LF, Tudella E, Soares-Marangoni DA. Brief reaching training with "sticky mittens" in preterm infants: Randomized controlled trial. Human Movement Science 2019;63:138-47. - PubMed
Neel 2019 {published data only}
    1. Neel ML, Yoder P, Matusz PJ, Murray MM, Miller A, Burkhardt S, et al. Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants. BMC Pediatrics 2019;19(1):1-10. - PMC - PubMed
Newnham 2009 {published data only}
    1. Newnham CA, Milgrom J, Skouteris H. Effectiveness of a modified Mother-Infant Transaction Program on outcomes for preterm infants from 3 to 24 months of age. Infant Behaviour and Development 2009;32(1):17-26. - PubMed
Oberg 2012 {published data only}
    1. Oberg GK, Campbell SK, Girolami GL, Ustad T, Jørgensen L, Kaaresen PI. Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences. BMC Pediatrics 2012;12:15. [PMID: ] - PMC - PubMed
Pelc 2017 {published data only}
    1. Pelc K, Daniel I, Wenderickx B, Dan B, Primebrain group. Multicentre prospective randomised single-blind controlled study protocol of the effect of an additional parent-administered sensorimotor stimulation on neurological development of preterm infants: Primebrain. BMJ Open 2017;7(12):e018084. [PMID: 10.1136/bmjopen-2017-018084] - DOI - PMC - PubMed
Piper 1986 {published data only}
    1. Piper MC, Kunos VI, Willis DM, Mazer BL, Ramsay M, Silver KM. Early physical therapy effects on the high-risk infant: a randomized controlled trial. Pediatrics 1986;78(2):216-24. - PubMed
Romera‐Galisteo 2019 {published data only}
    1. Romero-Galisteo RP, Blanco-Villaseñor Á, Moreno-Morales N, Gálvez-Ruiz P. Early intervention and perceived quality: refinement of the inventory of quality in early intervention centers. Medicine (Baltimore) 2019;98(15):e15173. - PMC - PubMed
Ross 1984 {published data only}
    1. Ross GS. Home intervention for premature infants of low-income families. American Journal of Orthopsychiatry 1984;54(2):263-70. - PubMed
Scott 1989 {published data only}
    1. Scott DT, Spiker D. Research on the sequelae of prematurity: early learning, early interventions and later outcomes. Seminars in Perinatology 1989;13(6):495-505. - PubMed
Sgandurra 2014 {published data only}
    1. Sgandurra G, Bartalena L, Cecchi F, Cioni G, Giampietri M, Greisen G et al. A pilot study on early home-based intervention through an intelligent baby gym (CareToy) in preterm infants. Research in Developmental Disabilities 2016;53-54:32-42. - PubMed
    1. Sgandurra G, Beani E, Inguaggiato E, Lorentzen J, Bo Nielsen J, Cioni, G. Effects on parental stress of early home-based CareToy intervention in low-risk preterm infants. Neural Plasticity 2019;2019:Article ID 7517351. - PMC - PubMed
    1. Sgandurra, G, Bartalena, L, Cioni, G et al. Home-based, early intervention with mechatronic toys for preterm infants at risk of neurodevelopmental disorders (CARETOY): a RCT protocol. BMC Pediatrics 2014;14:268. [DOI: 10.1186/1471-2431-14-268] - DOI - PMC - PubMed
Sgandurra 2018 {published data only}
    1. Sgandurra G, Beani E, Giampietri M, Rizzi R, Cioni G, CareToy-R Consortium. Early intervention at home in infants with congenital brain lesion with CareToy revised: a RCT protocol. BMC Pediatrics 2018;18(1):295. - PMC - PubMed
Silveira 2018 {published data only}
    1. Silveira RC, Mendes EW, Fuentefria RN, Valentini NC, Procianoy RS. Early intervention program for very low birth weight preterm infants and their parents: a study protocol.. BMC Pediatrics 2018;18(1):268. - PMC - PubMed
Slater 1987 {published data only}
    1. Slater MA, Naqvi M, Andrew L, Haynes K. Neurodevelopment of monitored versus non-monitored very low birth weight infants: the importance of family influences. Journal of Developmental and Behavioral Pediatrics 1987;8(5):278-85. - PubMed
Van Hus 2016 {published data only}
    1. Van Hus J, Jeukens-Visser M, Koldewijn K, Holman R, Kok JH, Nollet F, et al. Early intervention leads to long-term developmental improvements in very preterm infants, especially infants with bronchopulmonary dysplasia. Acta Paediatrica 2016;105(7):773-781. - PubMed
Walker 2010 {published data only}
    1. Walker SP, Chang SM, Younger N, Grantham-McGregor SM. The effect of psychosocial stimulation on cognition and behaviour at 6 years in a cohort of term, low-birthweight Jamaican children. Developmental Medicine and Child Neurology 2010;52(7):e148-54. - PubMed
Wasik 1990 {published data only}
    1. Wasik BH, Ramey CT, Bryant DM, Sparling JM. A longitudinal study of two early intervention strategies: Project CARE. Child Development 1990;61(6):1682-96. - PubMed
Weerasinghe 2023 {published data only}
    1. Weerasinghe Y, Sumanasena SP. Family- centered, early intervention package for infants at high risk for Neuro- Developmental Disabilities to promote language development during early infancy; a randomized controlled trial. International Clinical Trials Registry Platform 2023. [ICTRP ID: SLCTR/2022/001]
Welch 2015 {published data only}
    1. Welch MG, Firestein MR, Austin J, Hane AA, Stark RI, Hofer MA, et al. Family Nurture Intervention in the neonatal intensive care unit improves social-relatedness, attention, and neurodevelopment of preterm infants at 18 months in a randomized controlled trial. Journal of Child Psychology and Psychiatry 2015;56(11):1202-1211. - PubMed
Welch 2016 {published data only}
    1. Welch MG, Halperin MS, Austin J, Stark RI, Hofer MA, Hane AA, et al. Depression and anxiety symptoms of mothers of preterm infants are decreased at 4 months corrected age with Family Nurture Intervention in the NICU.. Archives Womens Mental Health 2016;19(1):51-61. - PubMed
Widmayer 1981 {published data only}
    1. Widmayer SM, Field TM. Effects of Brazelton demonstrations for mothers on the development of preterm infants. Pediatrics 1981;67(5):711-4. - PubMed
Williams 2015 {published data only}
    1. Williams JL, Corbetta D, Guan Y. Learning to reach with "sticky" or "non-sticky" mittens: a tale of developmental trajectories. Infant Behavior and Development 2015;38:82-96. - PubMed
Winter 2018 {published data only}
    1. Winter L, Sanders MR, N Boyd R, Pritchard M, Gray PH, Whittingham K, et al. Predicting attendance of a preventive parenting intervention for very preterm infants. Infant Mental Health Journal 2018;39(6):699-706. - PubMed
Wu 2016 {published data only}
    1. Wu YC, Hsieh WS, Hsu CH, Chang JH, Chou HC, Hsu HC, et al. Intervention effects on emotion regulation in preterm infants with very low birth weight: a randomized controlled trial. Research in Developmental Disabilities 2016;48:1-12. - PubMed
Yu 2017 {published data only}
    1. NCT01807533. A family-centered intervention program for preterm infants: effects and their biosocial pathways. clinicaltrials.gov/study/NCT01807533 (first received 29 January 2013). [CENTRAL: CN-01540934]
    1. Yu YT, Hsieh WS, Hsu CH, Lin YJ, Lin CH, Hsieh S, et al. Family-centered care improved neonatal medical and neurobehavioral outcomes in preterm infants: randomized controlled trial. Physical Therapy 2017;97(12):1158-1168. - PubMed
Zanelli 2019 {published data only}
    1. Zanelli S. NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy. ClinicalTrials.gov 2019. [CLINICALTRIALS.GOV ID: NCT04330859]

References to ongoing studies

ACTRN12621000364875 {published data only}
    1. ACTRN12621000364875. The effect of telehealth for early intervention on neurodevelopmental outcomes of infants born very preterm and their parent’s well-being: a randomised controlled trial (TEDI-Prem) [TEDI-prem: telehealth for early developmental Intervention in babies born very preterm]. trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12621000364875 (first received 31 March 2021). [CENTRAL: CN-02256202]
Baraldi 2020 {published data only}
    1. Baraldi E, Allodi Mara W, Lowing K, Smedler AC, Westrup B, Aden U. Stockholm preterm interaction-based intervention (SPIBI) - study protocol for an RCT of a 12-month parallel-group post-discharge program for extremely preterm infants and their parents. BMC Pediatrics 2020;20(1):49. [DOI: 10.1186/s12887-020-1934-4.] [PMID: ] - DOI - PMC - PubMed
CTRI/2022/03/040781 {published data only}
    1. CTRI/2022/03/040781. A randomised controlled trial to assess the effectiveness of nurse led developmental intervention packages on neurodevelopmental outcome of preterm babies in AIIMS, Jodhpur [Effect of nurse led developmental intervention packages on neurodevelopmental outcome of preterm babies in AIIMS, Jodhpur]. trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2022/03/040781 (first received 3 March 2022). [CENTRAL: CN-02408965]
Dusing 2020 {published data only}
    1. Dusing SC, Burnsed JC, Brown SE, Harper AD, Hendricks-Munoz KD, Stevenson RD, et al. Efficacy of supporting play exploration and early development intervention in the first months of life for infants born very preterm: 3-arm randomized clinical trial protocol. Physical Therapy 2020;100(8):1343-52. [PMID: 10.1093/ptj/pzaa077] [PMID: ] - DOI - PMC - PubMed
IRCT20220725055554N1 {published data only}
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References to other published versions of this review

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