P0340 - Use of a Novel Human Milk-Based Fortifier in Term Infants with Surgical Congenital Gastrointestinal Disorders Improves Growth at Discharge

Background/Purpose: Human milk (HM) is the ideal source of nutrition for all infants, but alone is insufficient in protein and calories for infants with surgical congenital gastrointestinal disorders (S-CGD) and critically ill infants. Currently, the only option for term infants is fortification with formulas which have been associated with increased risk of necrotizing enterocolitis (NEC) in the preterm population and may contribute to the high rates of NEC in those infants with congenital gastrointestinal disorders. Therefore, a human milk-based fortifier (HMBF) formulated for term infants with S-CGD is needed to provide optimal nutrition during critical illness and recovery from surgery. The purpose of this study is to demonstrate the safety and efficacy of a novel HMBF designed for term infants with S-CGD.


Methods: This is a cohort of an ongoing multi-center, prospective, case-control, open-label comparative effectiveness trial of approximately 150 infants with qualifying surgical intestinal disorders (gastroschisis, omphalocele and intestinal atresias). Patients were fed an exclusive human milk diet consisting of mother’s own milk (MOM), and pasteurized donor human milk (PDHM, Prolacta Bioscience) fortified with a novel HMBF (PBCLN-002, Prolacta Bioscience) specifically formulated for the term infant. The first 26 term infants enrolled in this trial were evaluated for safety and efficacy of PBCLN-002 compared to a recent cohort of patients fed diets containing MOM and formula. The retrospective cohort was matched based on diagnosis, sex, birthweight and gestational age.


Results: Baseline characteristics were well matched between the groups (Table 1). There were no adverse events in the PBCLN group and no significant effect on feeding tolerance, interruptions or maximum direct bilirubin. Babies receiving PBCLN-002 grew faster in terms of weight velocity, length velocity and comparative head circumference velocity; however, these were not statistically significant. Discharge weight and length were significantly higher for the PBCLN group as compared to the retrospective cohort (Table 2). Adjusting for baseline using a basic analysis of covariance model, these differences remained significant for discharge weight (p=0.02) and discharge length (p=0.003), and marginally for discharge head circumference (p=0.13).

Conclusions: In this small cohort of patients with surgical congenital gastrointestinal disorders including gastroschisis, omphalocele and intestinal atresia, PBCLN-002 demonstrates safety and efficacy by increased growth at the time of discharge. The non-significant differences in daily weight gain and growth velocities between these two groups may reflect the small sample size and differences in parenteral nutrition support during the early phases of surgical recovery.