The Feasibility of Cream for Treatment of Neonatal Hypoglycemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2026-12-31

Brief Summary

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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?

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Detailed Description

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Conditions

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Neonatal Hypoglycemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prolact CR

One arm receiving Prolact CR for hypoglycemia

Group Type OTHER

Prolact CR for hypoglycemia

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Prolact CR for hypoglycemia

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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)