635 - Pilot Trial of Pasteurized Donor Human Milk-Derived Fat Supplement for the Treatment of Neonatal Hypoglycemia

Publication Number: 1612.635

Arpitha Chiruvolu, Baylor University Medical Center, Dallas, TX, United States; Karen Stanzo, Baylor Scott & White Health, McKinney, TX, United States; Jordan Reis, Pediatrix, Dallas, TX, United States; Kimberly Miklis, Pediatrix, Allen, TX, United States; Traci Szostek, Baylor Scott and White McKinney, Lipan, TX, United States; Kerry Zihlman, Baylor Scott and White McKinney, Celina, TX, United States; Heather Garner, Baylor Mckinney, McKinney, TX, United States; Melissa Meyers, Baylor Scott and White Mckinney, Melissa, TX, United States; Melanie Campbell, Baylor Scott & White McKinney Hospital, Anna, TX, United States; Kimberly Lumsden, Baylor Scott & White, McKinney, Melissa, TX, United States

Background: Neonatal hypoglycemia (NH) is a common metabolic disturbance in term and late preterm newborns admitted to the couplet care unit. Newborns at risk for NH include those who are born to mothers with diabetes, late preterm, or their birth weight meets criteria for small or large for gestational age. Approximately 30% of newborns have risk factors, and 15% experience at least one episode of NH.

Gluconeogenesis is a crucial process for maintaining glucose homeostasis after birth in newborns at risk for NH. Oral 40% glucose gel (gel) commonly used for the treatment of NH may increase blood glucose levels transiently, but has no effect on gluconeogenesis. Whereas, the fat in the human colostrum plays a vital role in providing energy, substrate, and regulatory signals that stimulate gluconeogenesis.

Objective: To examine the feasibility of utilizing a pasteurized donor human milk-derived fat supplement (Prolact CR, cream) to treat NH in the couplet care unit. We hypothesized that a dose of 3 mL/kg of cream (0.2 g/kg of carbohydrate and 0.75 g/kg of fat) would increase and stabilize the blood glucose levels in the newborns experiencing NH. We also speculated that cream would be tolerated with no adverse effects, and caregivers (nurses and parents) would find its use feasible and acceptable.

Design/Methods: This is a pilot descriptive study of 25 asymptomatic at-risk newborns who were enrolled after parental consent during the time period of October 14, 2024, and April 23, 2025. They were treated for NH with at least one dose of cream instead of 0.5 ml/kg of gel. All the other aspects of postnatal glucose homeostasis protocol remained same. (Figure 1)

Results: One newborn (4%) was admitted to the NICU for intravenous (IV) dextrose infusion. Among the 24 newborns who were discharged from the couplet care unit, 20 (83%) received one dose, and four were given two doses. None of these infants received gel or IV dextrose bolus. The newborns experienced a rise in blood glucose after each dose of cream, with the median increase from 36 to 56 mg/dL. The majority (92%) were discharged home feeding exclusive human milk. Cream was tolerated well with no adverse effects. The median hospital length of stay was 2 days. (Tables 1 & 2) Surveys revealed 100% satisfaction from caregivers indicating feasibility and acceptability.

Conclusion(s): Cream may be a promising natural option for management of transient NH in the asymptomatic newborns in couplet care unit. A larger noninferiority trial comparing cream to gel is currently underway in our institution. clinicaltrials.gov #NCT07217483

Figure 1: Screening and Management of Postnatal Glucose in newborns at-risk for hypoglycemia in Couplet Care Unit Utilizing Cream


Table 1: Maternal & infant characteristics


Table 2: Process variables & outcomes