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Meta-Analysis
. 2024 Sep 6;9(9):CD002971.
doi: 10.1002/14651858.CD002971.pub6.

Donor human milk for preventing necrotising enterocolitis in very preterm or very low-birthweight infants

Maria Quigley  1 , Nicholas D Embleton  2 , Nicholas Meader  3 , William McGuire  4
Affiliations
Meta-Analysis

Donor human milk for preventing necrotising enterocolitis in very preterm or very low-birthweight infants

Maria Quigley et al. Cochrane Database Syst Rev. .

Abstract

Background: When sufficient maternal milk is not available, donor human milk or formula are the alternative forms of enteral nutrition for very preterm or very low-birthweight (VLBW) infants. Donor human milk may retain the non-nutritive benefits of maternal milk and has been proposed as a strategy to reduce the risk of necrotising enterocolitis (NEC) and associated mortality and morbidity in very preterm or VLBW infants.

Objectives: To assess the effectiveness of donor human milk compared with formula for preventing NEC and associated morbidity and mortality in very preterm or VLBW infants when sufficient maternal milk is not available.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Maternity and Infant Care (MIC) database, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), from the earliest records to February 2024. We searched clinical trials registries and examined the reference lists of included studies.

Selection criteria: Randomised or quasi-randomised controlled trials comparing feeding with donor human milk versus formula in very preterm (< 32 weeks' gestation) or VLBW (< 1500 g) infants.

Data collection and analysis: Two review authors evaluated the risk of bias in the trials, extracted data, and synthesised effect estimates using risk ratio, risk difference, and mean difference, with associated 95% confidence intervals. The primary outcomes were NEC, late-onset invasive infection, and all-cause mortality before hospital discharge. The secondary outcomes were growth parameters and neurodevelopment. We used the GRADE approach to assess the certainty of the evidence for our primary outcomes.

Main results: Twelve trials with a total of 2296 infants fulfilled the inclusion criteria. Most trials were small (average sample size was 191 infants). All trials were performed in neonatal units in Europe or North America. Five trials were conducted more than 40 years ago; the remaining seven trials were conducted in the year 2000 or later. Some trials had methodological weaknesses, including concerns regarding masking of investigators and selective reporting. Meta-analysis showed that donor human milk reduces the risk of NEC (risk ratio (RR) 0.53, 95% confidence interval (CI) 0.37 to 0.76; I² = 4%; risk difference (RD) -0.03, 95% CI -0.05 to -0.01; 11 trials, 2261 infants; high certainty evidence). Donor human milk probably has little or no effect on late-onset invasive infection (RR 1.12, 0.95 to 1.31; I² = 27%; RD 0.03, 95% CI -0.01 to -0.07; 7 trials, 1611 infants; moderate certainty evidence) or all-cause mortality (RR 1.00, 95% CI 0.76 to 1.31; I² = 0%; RD -0.00, 95% CI -0.02 to 0.02; 9 trials, 2116 infants; moderate certainty evidence).

Authors' conclusions: The evidence shows that donor human milk reduces the risk of NEC by about half in very preterm or VLBW infants. There is probably little or no effect on late-onset invasive infection or all-cause mortality before hospital discharge.

Trial registration: ClinicalTrials.gov NCT00506584 NCT01686477 NCT01232725 NCT01390753.

PubMed Disclaimer

Conflict of interest statement

MQ was a deputy Co‐ordinating Editor for Cochrane Common Mental Disorders; she did not participate in the acceptance or editorial processes for this review.

NDE declares research grants paid to his employer for a trial using commercially prepared, human milk derived products from Prolacta Bioscience, 2017; a grant from Danone Early Life Nutrition for a study on feeding in late and moderately preterm infants, 2018; and a grant for a trial of human milk‐derived fortifier from NeoKare, 2022. NDE declares lecture honoraria from Nestle Nutrition Institute donated to charity in 2021 and 2023. NDE declares no financial relationships or benefits. NDE is a member of the UK Association for Milk Banking.

NM has nothing to declare.

WM is a Co‐ordinating Editor for Cochrane Neonatal; he did not participate in the acceptance or editorial processes for this review.

Figures

1
1
Study flow diagram: 2024 review update.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary.
4
4
Funnel plot: donor human milk versus formula ‐ necrotising enterocolitis.
1.1
1.1. Analysis
Comparison 1: Donor human milk versus formula, Outcome 1: Necrotising enterocolitis
1.2
1.2. Analysis
Comparison 1: Donor human milk versus formula, Outcome 2: Late‐onset invasive infection
1.3
1.3. Analysis
Comparison 1: Donor human milk versus formula, Outcome 3: All‐cause mortality
1.4
1.4. Analysis
Comparison 1: Donor human milk versus formula, Outcome 4: In‐hospital rate of weight gain (g/kg/day) until term equivalent
1.5
1.5. Analysis
Comparison 1: Donor human milk versus formula, Outcome 5: In‐hospital rate of head circumference growth (mm/week) until term equivalent
1.6
1.6. Analysis
Comparison 1: Donor human milk versus formula, Outcome 6: Weight (kg) at 18 months post‐term
1.7
1.7. Analysis
Comparison 1: Donor human milk versus formula, Outcome 7: Head circumference (cm) at 18 months post‐term
1.8
1.8. Analysis
Comparison 1: Donor human milk versus formula, Outcome 8: Bayley Mental Development Index at 18 months
1.9
1.9. Analysis
Comparison 1: Donor human milk versus formula, Outcome 9: Bayley Psychomotor Development Index at 18 months
1.10
1.10. Analysis
Comparison 1: Donor human milk versus formula, Outcome 10: Bayley‐III
1.11
1.11. Analysis
Comparison 1: Donor human milk versus formula, Outcome 11: Cerebral palsy
1.12
1.12. Analysis
Comparison 1: Donor human milk versus formula, Outcome 12: Hearing impairment
1.13
1.13. Analysis
Comparison 1: Donor human milk versus formula, Outcome 13: Visual impairment
1.14
1.14. Analysis
Comparison 1: Donor human milk versus formula, Outcome 14: Bayley‐III score < 70
1.15
1.15. Analysis
Comparison 1: Donor human milk versus formula, Outcome 15: Neurodevelopmental disability at 18 months
See this image and copyright information in PMC

Update of

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References to ongoing studies

NCT01232725 {published data only}
    1. NCT01232725. Donor human milk and neurodevelopmental outcomes in very low birthweight (VLBW) infants [Clinical epidemiologic and biologic studies of donor human milk and breastfeeding]. clinicaltrials.gov/study/NCT01232725 (first received 02 November 2010). [CENTRAL: CN-01501660]
NCT01390753 {published data only}
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References to other published versions of this review

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