The Feasibility of Cream for Treatment of Neonatal Hypoglycemia

NCT07217483 | Recruiting

• 1 other identifier: 023-279
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Neonatal Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• NICU admission

  Admission to neonatal intensive care unit for intravenous dextrose for treatment of hypoglycemia

  Birth to hospital discharge at 2 to 5 days of life

Study Arms (1)

Prolact CR

OTHER

One arm receiving Prolact CR for hypoglycemia

Dietary Supplement: Prolact CR for hypoglycemia

Interventions

Prolact CR for hypoglycemia DIETARY_SUPPLEMENT

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

Prolact CR

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns at risk for hypoglycemia (born to mothers with diabetes, small for gestational age, large for gestational age, late preterm born 35 to 37 weeks gestational age)

You may not qualify if:

• Newborns with major congenital anomalies
• Newborns directly admitted to the NICU form delivery room

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Medical Center - McKinney

McKinney, Texas, 75071, United States

RECRUITING

Study Officials

• Arpitha Chiruvolu, MD

  Baylor Scott & White Medical Center - McKinney

  STUDY CHAIR

Central Study Contacts

Karen Stanzo, PhD

CONTACT

469-764-6282; Karen.Stanzo@bswhealth.org

Arpitha Chiruvolu, MD

CONTACT

Arpitha.Chiruvolu@bswhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study the newborns with low blood glucose, but have no symptoms, will be managed by giving 3 ml/kg of Prolact CR (cream) instead of 0.5 ml/kg of 40% oral dextrose gel. Blood glucose will be monitored one hour after the cream is given. If needed, according to the protocol baby will receive up to three doses of cream. If baby has symptoms with low blood glucose, will receive intravenous dextrose.

Study Record Dates

• First Submitted: October 12, 2025
• First Posted: October 16, 2025
• Study Start: October 14, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)