Neonatal Hypoglycemia
Conditions
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. 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?
Interventions
DIETARY_SUPPLEMENTProlact CR for hypoglycemia
Utilizing Prolact CR instead of dextrose gel for management of newborn hypoglycemia
Sponsors
Baylor Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NICU admission | Birth to hospital discharge at 2 to 5 days of life | Admission to neonatal intensive care unit for intravenous dextrose for treatment of hypoglycemia |
Countries
United States
Contacts
Primary ContactKaren Stanzo, PhD
Backup ContactArpitha Chiruvolu, MD
Outcome results
None listed