The Feasibility of Prolacta CR for Treatment of Neonatal Hypoglycemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Baylor Research Institute
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- NICU admission
Study Overview
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
- What percentage of newborns receiving cream for treatment of hypoglycemia will need NICU admission for IV dextrose?
- How many median doses of cream are needed?
- What percentage of infants will be discharge exclusively feeding human milk from couplet care unit?
- What percentage of the surveys will show parent/nursing satisfaction with the product?
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 24 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Prolact CR
One arm receiving Prolact CR for hypoglycemia
Intervention: Prolact CR for hypoglycemia (Dietary Supplement)
Outcomes
Primary Outcomes
NICU admission
Time Frame: Birth to hospital discharge at 2 to 5 days of life
Admission to neonatal intensive care unit for intravenous dextrose for treatment of hypoglycemia
Secondary Outcomes
No secondary outcomes reported