Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Oct 1;179(10):1065-1073.
doi: 10.1001/jamapediatrics.2025.2365.

Supplemental Donor Milk vs Infant Formula in Moderate to Late Preterm Infants: A Randomized Clinical Trial

Alice R Rumbold  1   2   3 , Melissa M Lai  4   5 , Deanne August  4 , Pieter Koorts  4 , Tim Donovan  4 , Lisa Yelland  1   6 , Maria Makrides  1 , Alana R Cuthbert  1   3 , Laura D Klein  7 , Teresa Ginis  2 , Aya Al Gharram  1   2 , Susie Jones  2 , Laura Summers  2 , Andrew McPhee  1 , Amy Keir  1   2
Affiliations
Randomized Controlled Trial

Supplemental Donor Milk vs Infant Formula in Moderate to Late Preterm Infants: A Randomized Clinical Trial

Alice R Rumbold et al. JAMA Pediatr. .

Abstract

Importance: High-quality evidence supports the use of pasteurized donor human milk (donor milk) in very preterm infants with insufficient maternal milk available. However, evidence to guide the use of donor milk in more mature preterm infants is lacking.

Objective: To compare the effect of donor milk vs term infant formula, used to supplement insufficient maternal milk, on the time to establish full enteral feeds in moderate to late preterm infants.

Design, setting, and participants: This multisite, blinded randomized clinical trial was conducted from July 6, 2021, to April 5, 2023, at 2 Australian neonatal units. Infants 4 days old or younger, born between 32 + 0 and 36 + 6 weeks' gestation, with a birth weight of 1500 g or higher, and admitted to a neonatal unit were eligible if they were clinically stable, ready to commence or had commenced enteral feeds, and had insufficient maternal milk available. Infants were followed up until 6-month corrected age (CA). Follow-up assessments until 6-month CA were completed by December 4, 2023, and data analyses were completed by January 23, 2025.

Intervention: Infants were randomly assigned to receive supplemental donor milk or term formula for up to 8 days, stratified by site and gestational age at birth.

Main outcomes and measures: The primary outcome was time to full enteral feeds (defined as 150 mL/kg/day). Secondary outcomes included feed intolerance, growth, body composition, breast milk feeding, and hospital readmissions to 6-month CA.

Results: Of 201 infants randomized (99 to donor milk, 102 to formula), the mean (SD) birth gestational age was 34.6 (1.2) weeks, mean (SD) birth weight was 2267.1 (450.8) g, 88 infants (43.8%) were female, and 75 infants (37.3%) were a twin or triplet. Mean (SD) time to reach full enteral feeds did not differ between groups (donor milk group: 5.7 [2.6] days; formula group: 5.8 [3.4] days; adjusted mean difference, -0.07; 95% CI, -0.90 to 0.76). Secondary outcomes were similar between groups, except that infants in the donor milk group had a lower rate of birth weight regain compared with the formula group (mean [SD] time to regain in donor milk group: 10.7 [5.7] days; formula group: 8.4 [4.4] days; hazard ratio, 0.65; 95% CI, 0.47-0.88).

Conclusions and relevance: In this multisite randomized clinical trial, supplemental donor milk did not reduce time to full enteral feeds in moderate to late preterm infants compared with term formula for up to 8 days.

Trial registration: anzctr.org.au Identifier: ACTRN12621000529842.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Rumbold reported grants from the Australian National Health and Medical Research Council and the Clive and Vera Ramaciotti Foundation and nonfinancial support from Australian Red Cross Lifeblood in the form of donor milk provided free of charge to hospitals during the conduct of the study. Dr Lai reported grants from the South Australian Health and Medical Research Institute (SAHMRI) in the form of per-participant payments for recruits at Royal Brisbane and Women’s Hospital during the conduct of the study. Dr August reported consultancy fees from Navi Technologies outside the submitted work. Dr Koorts reported grants from SAHMRI in the form of per-participant payments for recruits during the conduct of the study. Dr Yelland reported grants from the Australian National Health and Medical Research Council and the Clive and Vera Ramaciotti Foundation during the conduct of the study and a research grant from the Fonterra Co-operative Group outside the submitted work. Dr Makrides reported grants from the Australian National Health and Medical Research Council during the conduct of the study and grants from Fonterra Co-operative Group outside the submitted work. Dr Klein reported grants from the Baxter International Foundation and the Commonwealth Department of Health during the conduct of the study and employment by Australian Red Cross Lifeblood, a nonprofit organization that provides pasteurized donor human milk from voluntary, nonremunerated donors to hospitals in Australia. Ms Summers reported work as a lactation consultant in the Milk Bank Portfolio at the Women’s and Children’s Hospital outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Enrollment, Randomization, and Participant Flow Diagram
See this image and copyright information in PMC

References

    1. Ohuma EO, Moller AB, Bradley E, et al. National, regional, and global estimates of preterm birth in 2020, with trends from 2010: a systematic analysis. Lancet. 2023;402(10409):1261-1271. doi: 10.1016/S0140-6736(23)00878-4 - DOI - PubMed
    1. Boyle EM, Johnson S, Manktelow B, et al. Neonatal outcomes and delivery of care for infants born late preterm or moderately preterm: a prospective population-based study. Arch Dis Child Fetal Neonatal Ed. 2015;100(6):F479-F485. doi: 10.1136/archdischild-2014-307347 - DOI - PMC - PubMed
    1. Khan KA, Petrou S, Dritsaki M, et al. Economic costs associated with moderate and late preterm birth: a prospective population-based study. BJOG. 2015;122(11):1495-1505. doi: 10.1111/1471-0528.13515 - DOI - PubMed
    1. Blencowe H, Lee AC, Cousens S, et al. Preterm birth-associated neurodevelopmental impairment estimates at regional and global levels for 2010. Pediatr Res. 2013;74(suppl 1):17-34. doi: 10.1038/pr.2013.204 - DOI - PMC - PubMed
    1. Johnson S, Evans TA, Draper ES, et al. Neurodevelopmental outcomes following late and moderate prematurity: a population-based cohort study. Arch Dis Child Fetal Neonatal Ed. 2015;100(4):F301-F308. doi: 10.1136/archdischild-2014-307684 - DOI - PMC - PubMed

Publication types