The Feasibility of Cream for Treatment of Neonatal Hypoglycemia

Baylor Scott and White Health (BSWH)

Status: Enrolling

Conditions: Neonatal Hypoglycemia

Treatments: Dietary Supplement: Prolact CR for hypoglycemia

Study type: Interventional

Funder types: Other

Identifiers

NCT07217483

023-279

Details and patient eligibility

About

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?

Enrollment: 75 estimated patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

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)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Prolact CR

Other group

Description:

One arm receiving Prolact CR for hypoglycemia

Treatment:

Dietary Supplement: Prolact CR for hypoglycemia