Trials / Completed
CompletedNCT02523222
Dextrose Gel Does Not Prevent Neonatal Hypoglycemia
Prophylactic Dextrose Gel Does Not Prevent Neonatal Hypoglycemia: a Quasi-experimental Pilot Study
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 236 (actual)
- Sponsor
- Baylor College of Medicine · Academic / Other
- Sex
- All
- Age
- 0 Hours – 1 Hour
- Healthy volunteers
- Not accepted
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.
Conditions
- Hypoglycemia
- Infant, Small for Gestational Age
- Premature Birth of Newborn
- Fetal Macrosomia
- Intrauterine Growth Restriction
- Complication of Prematurity
- Neonatal Hypoglycemia
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 40% Dextrose gel | 40% dextrose gel will be rubbed into the hypoglycemic infant's buccal mucosa at a dose of 0.5ml/kg. |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2018-03-01
- Completion
- 2018-07-30
- First posted
- 2015-08-14
- Last updated
- 2025-01-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02523222. Inclusion in this directory is not an endorsement.