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Randomized Controlled Trial
. 2024 May;41(S 01):e2427-e2435.
doi: 10.1055/s-0043-1771261. Epub 2023 Aug 30.

A Pilot Single-Site Randomized Control Trial: Investigating the Use of Donor Milk in Late Preterm and Term Infants in the Neonatal Intensive Care Unit

Neema Pithia  1 , Tristan Grogan  2 , Meena Garg  1 , Kalpashri Kesavan  1 , Kara L Calkins  1
Affiliations
Randomized Controlled Trial

A Pilot Single-Site Randomized Control Trial: Investigating the Use of Donor Milk in Late Preterm and Term Infants in the Neonatal Intensive Care Unit

Neema Pithia et al. Am J Perinatol. 2024 May.

Abstract

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.

Key points: · 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..

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Conflict of interest statement

K.L.C. has received research support from Fresenius Kabi. K.L.C. has served as an advisor for Fresenius Kabi, Mead Johnson, Baxter, and Prolacta. K.L.C. serves as an institutional principal investigator, with no salary funding, for a consortium database sponsored by Mead Johnson.

Figures

Figure 1.
Figure 1.. Study consent and completion rate.
MOM; mother’s own milk. DM; donor milk. F; formula. *Infant fed with formula for one feed in MOM+DM group was not excluded from the study given the limited deviation.
Figure 2.
Figure 2.. Weight, Length, and Head Circumference (HC) measured at birth, 7 days of life, and follow-up (6–8 weeks of age) for each group. n=16.
MOM; mother’s own milk. DM; donor milk. F; formula. Error bars represent one standard error. Z-scores were obtained using PediTools Fenton 2013 data. P-values from the mixed effects models were: Weight; Group p=0.47, Time p=0.99, Group*time p=0.84. Length; Group p=0.81, Time p=0.16, Group*time p=0.09. Head Circumference; Group p=0.63, Time p=0.42, Group*time p=0.04. *p=0.04 using Student’s t test.
Figure 3.
Figure 3.. Number of feeds at breast and percentage of mother’s own milk consumed over time. n=16.
MOM; mother’s own milk. DM; donor milk. F; formula. a) Number of feeds at breast for each day of life in the MOM+DM and MOM+F groups. Error bars represent one standard error. P-values from mixed effects models are: Group p=0.41, Time p=0.02, Group*time p=0.01, *p=0.03 using Student’s t-test. b) Percentage of MOM as a percent of the total feeds for each day of life. Group p=0.23, Time p<0.001, Group*time p=0.16.
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