Dextrose Gel Does Not Prevent Neonatal Hypoglycemia

Baylor College of Medicine236 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

236

Conditions

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

Interventions

40% Dextrose gelDIETARY_SUPPLEMENT

40% dextrose gel will be rubbed into the hypoglycemic infant's buccal mucosa at a dose of 0.5ml/kg.

Eligibility

Sex: ALLMin age: 0 HoursMax age: 1 Hour

Medical Language ↔ Plain English

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

Locations (1)

Ben Taub Harris Health Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

Prophylactic administration of dextrose gel

Give infants who meet criteria for high-risk and whose parents have consented one dose of prophylactic 40% dextrose gel (0.5ml/kg) after first feed. Assess glucose level after 1 feed and 1 application of dextrose gel, and admission to the NICU, compared to controls with similar risk factors who are not treated prophylactically.

Time frame: 2 hours

Treatment failure of at-risk infants

Infants at-risk (IDM, late preterm, SGA, LGA, estimated fetal weight below 2.5kg or above 4kg, IUGR, or poor feeding) will be followed until hospital discharge to measure NICU admission data and glucose values during hospitalization.

Time frame: 4 days

Data from ClinicalTrials.gov

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