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A Pilot Single-Site Randomized Control Trial: Investigating the Use of Donor Milk in Late Preterm and Term Infants in the Neonatal Intensive Care UnitFunding Research was supported by the UCLA Children's Discovery and Innovation Institute (CDI) Resident Research Grant (CDI-RRG-100119). Statistical analyses for this project were supported by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health under the UCLA Clinical and Translational Science Institute (UL1TR001881).
Objective We aimed to study donor milk (DM) supplementation when mother's own milk (MOM) was unavailable in term and late preterm infants (LPIs) admitted to the neonatal intensive care unit (NICU). We hypothesized that this study would be feasible, defined by the rate of consent, diet adherence, and study completion. We further hypothesized that compared with formula supplementation, DM supplementation, for no longer than 7 days from birth, would be associated with an increase in breastfeeding attempts and the percentage of MOM (MOM%) without adversely affecting growth. Breastfeeding attempts and MOM% were assessed over 48 hours at the end of the intervention, which was defined as NICU discharge or at the end of supplementation, whichever came sooner.
Study Design This was a pilot study (n = 32). Infants with a gestational age > 34 weeks admitted to the NICU were included. Infants were randomized to one of two groups: human milk (MOM + DM) or formula (MOM + F).
Results The consent rate was 52%. Adherence to the study diet was 97%, and completion was 100%. When the MOM + DM group was compared with the MOM + F group, there was no difference in breastfeeding attempts (median [interquartile range]: 3.5 [1.5–6] vs. 1.5 [0.5–4] times, p = 0.1) or MOM% (60 vs. 59%, p = 0.9). Weight and length at multiple time points were similar when the groups were compared.
Conclusion A study randomizing term and LPIs in the NICU to DM or formula when MOM was unavailable is feasible. It remains unclear if DM improves breastfeeding success in this population.
A study that randomizes term and late preterm infants in the NICU to DM or formula supplementation when mother's own milk is not available is feasible.
It remains unclear if DM compared to formula supplementation improves direct breastfeeding.
In general, growth was similar in infants who received DM or formula as a supplement.
All authors contributed to the study and approved the final manuscript. Contributions included: Conceptualization, N.P., K.L.C., K.K., M.G.; methodology, N.P., K.L.C., K.K., M.G.; statistical analysis, N.P., T.G.; writing-original draft preparation, N.P., T.G., K.L.C.; writing-review and editing, N.P., T.G., K.K., M.G., K.L.C.; funding acquisition, N.P., T.G., K.L.C.
Received: 13 March 2023
Accepted: 19 June 2023
Article published online:
30 August 2023
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