TY - JOUR
T1 - Supplemental Donor Milk vs Infant Formula in Moderate to Late Preterm Infants
T2 - A Randomized Clinical Trial
AU - Rumbold, Alice R.
AU - Lai, Melissa M.
AU - August, Deanne
AU - Koorts, Pieter
AU - Donovan, Tim
AU - Yelland, Lisa
AU - Makrides, Maria
AU - Cuthbert, Alana R.
AU - Klein, Laura D.
AU - Ginis, Teresa
AU - Al Gharram, Aya
AU - Jones, Susie
AU - Summers, Laura
AU - McPhee, Andrew
AU - Keir, Amy
PY - 2025/10
Y1 - 2025/10
N2 - 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.
AB - 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.
KW - preterm infants
KW - nutrition
KW - maternal milk
KW - donor milk
UR - http://www.scopus.com/inward/record.url?scp=105017900957&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/NHMRC/1135155
UR - http://purl.org/au-research/grants/NHMRC/2024589
U2 - 10.1001/jamapediatrics.2025.2365
DO - 10.1001/jamapediatrics.2025.2365
M3 - Article
C2 - 40758360
AN - SCOPUS:105017900957
SN - 2168-6211
VL - 179
SP - 1065
EP - 1073
JO - JAMA pediatrics
JF - JAMA pediatrics
IS - 10
ER -