716 - Exclusive Human Milk Diet with Prolacta Does Not Prevent Necrotizing Enterocolitis in Extremely Preterm Infants

Publication Number: 716.4667

Randhir S. Yadav, University of Florida- Jacksonville, Jacksonville, FL, United States; P Sireesha. Nandula, University of Florida College of Medicine, Jacksonville, FL, United States; Vasantha HS. Kumar, University of Florida College of Medicine, Jacksonville, Jacksonville, FL, United States; Shiva Gautam, University of Florida College of Medicine, Jacksonville, FL, United States; Shumneva Shrestha, University of Florida College of Medicine, Jacksonville, FL, United States; Sanket D. Shah, University of Florida College of Medicine, Jackonsville, FL, United States

Background: Necrotizing enterocolitis (NEC) is a life-threatening condition with high mortality in extremely premature infants (EPI) < 28 weeks gestation. Human milk fortifier (HMF) is added to preterm human milk to optimize the growth and nutrition of premature infants. Bovine milk HMF (BM-HMF), a cow milk-based fortifier, and Prolacta, a human milk-based fortifier, are the two commonly used fortifiers in NICU. Studies have suggested that an exclusive human milk diet (EHMD) based on fortification with Prolacta had better outcomes, including less NEC than babies fed on BM-HMF. However, recent studies have not supported the routine use of fortification by Prolacta to decrease the incidence of NEC, sepsis, or mortality in premature infants. We compared the effects of EMHD with Prolacta and BM-HMF on NEC, sepsis, and mortality in EPI.

Objective: To study the relationship between human milk fortifiers (Prolacta and BM-HMF) and the development of NEC in extremely premature infants

Design/Methods: We conducted a retrospective analysis of infants who developed NEC (≥ stage 2), admitted to the University of Florida Health (UFH) and Wolfson Children’s Hospital (WCH) NICUs from 01/2017 to 12/2023. Infants with spontaneous intestinal perforation, NEC before HMF addition, who died before 7 days of age or with stage 1 NEC were excluded. A standardized feeding protocol is followed at both NICUs, with UFH using an EHMD with Prolacta and WCH using BM-HMF. Parametric and non-parametric statistical tests were applied as appropriate for data analysis.

Results: Of 749 eligible infants, 61 met study criteria with NEC incidence of 8.1% in the study population. Among the 61 infants, 33 infants (8.9%) on EHMD with Prolacta developed NEC, versus 28 infants (7.3%) in the BM-HMF group (Figure 1). Baseline characteristics were similar between the two groups, although SGA infants were significantly higher in the BM-HMF group (Table 1). NEC incidence and the need for surgical intervention were not different between the groups. Clinical outcomes, such as medical treatment for PDA, PDA surgery, sepsis, severe IVH, and mortality, were similar between the two groups (Table 2). Infants receiving EHMD had a higher rate of bowel perforation, compared to the BM-HMF group.

Conclusion(s): An exclusive human milk diet with Prolacta fortification did not decrease the incidence of medical or surgical NEC, sepsis, or mortality in our study population. The routine use of EHMD with Prolacta does not prevent NEC in EPI. A multicenter randomized controlled trial is needed to investigate the impact of EHMD and the multifactorial etiology of NEC in premature infants.

Table 1: Baseline characteristics among both groups
Data expressed as counts (percentages) in all rows except Gestational Age*; median (quartile range) and Birth weight**; Mean ± SD.
Statistically significant P value < 0.05
BM-HMF; cow milk-based human milk fortifier

Table 2: Primary and secondary outcomes
* Counts (percentage), # median (quartile range). ^ mean ± SD
BM-HMF; cow milk-based human milk fortifier, NEC; necrotizing enterocolitis, PDA; patent ductus arteriosus, PMA; postmenstrual age
Statistically significant P value < 0.05

Figure 1: Flow chart
EPI; extremely premature infants, HMF; human milk fortifier, NEC; necrotizing enterocolitis, UFH; University of Florida Health, WCH; Wolfson Children’s hospital

Table 1: Baseline characteristics among both groups
Data expressed as counts (percentages) in all rows except Gestational Age*; median (quartile range) and Birth weight**; Mean ± SD.
Statistically significant P value < 0.05
BM-HMF; cow milk-based human milk fortifier

Table 2: Primary and secondary outcomes
* Counts (percentage), # median (quartile range). ^ mean ± SD
BM-HMF; cow milk-based human milk fortifier, NEC; necrotizing enterocolitis, PDA; patent ductus arteriosus, PMA; postmenstrual age
Statistically significant P value < 0.05

Figure 1: Flow chart
EPI; extremely premature infants, HMF; human milk fortifier, NEC; necrotizing enterocolitis, UFH; University of Florida Health, WCH; Wolfson Children’s hospital