377 - Extended donor human milk access for infants with congenital gastrointestinal pathologies: a pilot randomized clinical trial

Publication Number: 3364.377

Katie M.. Strobel, University of Washington School of Medicine, Seattle, WA, United States; Rebecca Hoban, Seattle Children's, Seattle, WA, United States; Reece Alstat, Seattle Children's Hospital, Seattle, WA, United States; Gregory C. Valentine, University of Washington School of Medicine, Tacoma, WA, United States; D. Taylor Hendrixson, University of Washington School of Medicine, Seattle, WA, United States; Krystle Perez, University of Washington School of Medicine, Snohomish, WA, United States; Heather B.. Jaspan, Seattle Children's, Seattle, WA, United States; Danielle Wendel, University of Washington, Seattle, WA, United States; Patrick J.. Javid, University of Washington School of Medicine, Seattle, WA, United States

Background: Infants with congenital gastrointestinal (GI) pathologies experience lengthy hospitalization due to surgical needs, prolonged parenteral nutrition (PN) requirements, and complications, including infection, cholestasis, and poor growth. Emerging data support the benefits of extended donor human milk (eDHM) use when mother's own milk (MOM) is unavailable or insufficient.

Objective: The objective of this pilot randomized clinical trial (RCT) is to evaluate if eDHM lessens time to full feeds and improves provision of MOM in infants with GI pathologies.

Design/Methods: In this pilot RCT, infants born 34+ weeks of gestation with a diagnosis of a congenital GI pathology (gastroschisis, omphalocele, intestinal atresia, volvulus, or Hirschsprung's disease) and < 7 days old were eligible for inclusion. Enrolled infants received MOM as available and were randomized to: 1) eDHM (DHM until minimum 120mL/k/d of enteral feeds), or 2) standard hospital policy (72 hours DHM bridge followed by formula) if MOM was unavailable. The primary outcome was time to full feeds (defined as 120 ml/kg/d enteral); secondary outcomes included PN and central line days, proportion of MOM received, any MOM feeding at discharge, and growth (measured in anthropometric z-scores) from birth to discharge. We utilized multivariable linear regression or logistic regression, adjusting for GI pathology.

Results: 24 infants (85% of those eligible) were enrolled, and 13 were randomized to the extended DHM arm and 11 to the hospital policy arm. Cohort characteristics were similar between arms (Table 1). Proportion of MOM was high in both groups, with a trend towards a higher proportion of MOM feeds over time in the eDHM group compared to the hospital policy arm (Figure 1, p=0.06). After adjusting for GI pathology, there were no significant differences in time to full feeds, central line days, PN days, or changes in z-scores from birth to discharge (Figure 2). However, the extended DHM group had a higher median cumulative proportion of MOM than the hospital policy group (100% [95-100%] vs. 85% [73-100%], p=0.04). There were no differences in direct breastfeeding/chestfeeding at hospital discharge (46% vs. 46%).

Conclusion(s): Although there were no differences in feeding outcomes in this unpowered study, prolonged access to DHM showed potential benefit to the provision of MOM and no harm to in-hospital growth. Given ongoing practice shifts to increase donor milk availability, a larger multisite study is required to investigate our findings and explore post-discharge outcomes related to increased milk bioactive exposure.

Table 1.
Cohort characteristics. Continuous variables are presented as median (IQR) and nominal variables as percent (N). Parenteral nutrition days are the number of days dextrose and amino acids were ordered. Z-scores were calculated from the Fenton growth curve if <37 weeks and WHO growth curve if 37 weeks or older.

Figure 1.
Proportion of MOM to other enteral feeds during each week of hospitalization.

Figure 2.
Median (IQR) time to full feeds defined as 120 ml/kg/day of enteral feeds.