Clinical trial NCT02523222: Dextrose Gel Does Not Prevent Neonatal Hypoglycemia
Official title: Prophylactic Dextrose Gel Does Not Prevent Neonatal Hypoglycemia: a Quasi-experimental Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypoglycemia
Infant, Small for Gestational Age
Premature Birth of Newborn
Fetal Macrosomia
Intrauterine Growth Restriction
Complication of Prematurity
Neonatal Hypoglycemia
Keywords: dextrose gel
newborn hypoglycemia
late preterm infant
large for gestational age
small for gestational age
prophylactic
neonatal hypoglycemia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 236
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Study
Primary purpose: PREVENTION

Brief summary: This was a quasi-experimental pilot study comparing blood glucose values 30 minutes after feeding alone or feeding + dextrose gel in newborns at risk for transient neonatal hypoglycemia.

Detailed description: OBJECTIVE: To test the hypothesis that prophylactic dextrose gel administered to newborns at risk for hypoglycemia will increase the initial blood glucose (BG) concentration after the first feeding and subsequently decrease NICU admissions for treatment of asymptomatic transient neonatal hypoglycemia (TNH) vs those given feedings alone.

STUDY DESIGN: This quasi-experimental pilot study allocated asymptomatic at-risk newborns (late preterm, birth weight \<2500 or \>4000 g, and infants of diabetic mothers) to receive prophylactic dextrose gel (Insta-Glucose®); other at-risk newborns served as controls. After the initial feeding, the prophylactic group received dextrose gel (0.5 ml/kg) rubbed into the buccal mucosa, and BG was checked 30 min later. Initial BG concentrations and rate of NICU admissions (for treatment of hypoglycemia) were compared between the prophylactic group and controls using the Wilcoxon rank-sum test and Fisher's exact test, where appropriate. A multivariable linear regression compared first BG between groups after adjusting for at-risk categories and age at first BG concentration.

Eligibility criteria: Inclusion Criteria:

* Gestational age above 35 weeks
* Infants less than 1 hour of age
* Infants with informed parental consent
* Infants who are born at the Harris Health Ben Taub Hospital in Houston, TX

Exclusion Criteria:

* Infants with known metabolic, genetic, or congenital anomalies
* Infants not expected to survive the neonatal period
* Infants determined later to have a metabolic, genetic, or congenital anomaly that was not immediately obvious in the newborn period
* Hypoglycemic infants with symptoms
* Infants transferred to the Level 3 NICU for other reasons

Primary outcomes:
measure: Prophylactic administration of dextrose gel
timeFrame: 2 hours
measure: Treatment failure of at-risk infants
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub Harris Health Hospital
state: Texas
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Jeffrey R Kaiser, MD, MA, FAAP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coors SM, Cousin JJ, Hagan JL, Kaiser JR. Prophylactic Dextrose Gel Does Not Prevent Neonatal Hypoglycemia: A Quasi-Experimental Pilot Study. J Pediatr. 2018 Jul;198:156-161. doi: 10.1016/j.jpeds.2018.02.025. Epub 2018 Mar 28.