Dextrose Gel Does Not Prevent Neonatal Hypoglycemia

Baylor College of Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypoglycemia; Complication of Prematurity; Neonatal Hypoglycemia; Intrauterine Growth Restriction; Infant, Small for Gestational Age; Premature Birth of Newborn; Fetal Macrosomia

Treatments: Dietary Supplement: 40% Dextrose gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02523222

H-36132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 patients

Sex: All

Ages: Under 1 hour old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

CONTROL

No Intervention group

Description:

Infants at risk for transient neonatal hypoglycemia following standard-of-care.

Dextrose Gel

Active Comparator group

Description:

Infants given 40% Dextrose gel (0.5ml/kg) in the buccal mucosa after their first feed, within the first hour of life.

Treatment:

Dietary Supplement: 40% Dextrose gel