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The Feasibility of Cream for Treatment of Neonatal Hypoglycemia

NCT07217483 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-10-16

No results posted yet for this study

Summary

Prolact CR (cream) is a fat supplement that is derived from pasteurized human donor milk. It has been utilized in babies who are born premature in the neonatal intensive care unit (NICU) setting to improve growth while avoiding cow milk exposure. There is no literature on the use of cream as a treatment for low blood glucose levels in newborns who are at risk. It is known that fat in human colostrum plays a vital role in providing energy, substrate, and stimulates gluconeogenesis. Gluconeogenesis is the process that helps in the sustainment of blood glucose. Dextrose gel that is used to treat low blood glucose levels helps in raising the blood glucose, but does not help in sustainment.

The objective of this pilot study is to evaluate the utility, feasibility, and acceptability of administering cream for the treatment of newborn low blood glucose levels in a couplet care unit. Investigators hypothesized that 3 ml/kg of cream (0.2 g/kg of carbohydrate and 0.75 g/kg of fat), if given in the place of 0.5 ml/kg (0.2 g/kg of carbohydrate) would increase and stabilize the blood glucose levels. Investigators also speculated that newborns would tolerate the cream with no adverse effects, and caregivers (nurses and parents) would find its use feasible and acceptable.

Parents of newborns with risk factors for hypoglycemia \[born to mothers with diabetes, small for gestational age, large for gestational age, or late prematurity (35 to 37 weeks' gestation at birth) who intended to breastfeed exclusively will be approached to consent for the study either before or after delivery of the infant. Newborns with major congenital anomalies or those admitted immediately to the NICU after birth will be excluded.

The main questions hoping to answer

1. What percentage of newborns receiving cream for treatment of hypoglycemia will need NICU admission for IV dextrose?
2. How many median doses of cream are needed?
3. What percentage of infants will be discharge exclusively feeding human milk from couplet care unit?
4. What percentage of the surveys will show parent/nursing satisfaction with the product?

Conditions

  • Neonatal Hypoglycemia

Interventions

DIETARY_SUPPLEMENT

Prolact CR for hypoglycemia

Utilizing Prolact CR instead of dextrose gel for management of newborn hypoglycemia

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Arpitha Chiruvolu, MD · Baylor Scott & White Medical Center - McKinney

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-14
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217483 on ClinicalTrials.gov