The Feasibility of Cream for Treatment of Neonatal Hypoglycemia

Conditions

• Neonatal Hypoglycemia

Eligibility Criteria

Sex

ALL

Age

N/A - 24 Hours

Healthy Volunteers

Not accepted

Interventions

• Prolact CR for hypoglycemia — DIETARY_SUPPLEMENT
  Utilizing Prolact CR instead of dextrose gel for management of newborn hypoglycemia

Study Details

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?

Key Dates

Start date

Oct 14, 2024

Status verified

Oct 2025

Primary completion

Jun 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

75 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Prolact CR
  One arm receiving Prolact CR for hypoglycemia

Primary Outcome Measure

NICU admission [ Time Frame: Birth to hospital discharge at 2 to 5 days of life ]

Central Contacts

• Karen Stanzo, PhD
  469-764-6282
  [email protected]
• Arpitha Chiruvolu, MD
  [email protected]

Locations (1)

Find similar trials in McKinney, TX

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