Dextrose Gel Does Not Prevent Neonatal Hypoglycemia

Prophylactic Dextrose Gel Does Not Prevent Neonatal Hypoglycemia: a Quasi-experimental Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Hypoglycemia; Premature Birth of Newborn; Intrauterine Growth Restriction; Fetal Macrosomia; Infant, Small for Gestational Age; Neonatal Hypoglycemia; Complication of Prematurity
• Intervention / Treatment: Dietary supplement: 40% Dextrose gel

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.

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub Harris Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 hour (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONTROL; Infants at risk for transient neonatal hypoglycemia following standard-of-care.
Active Comparator: Dextrose Gel; Infants given 40% Dextrose gel (0.5ml/kg) in the buccal mucosa after their first feed, within the first hour of life.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 days

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Jeffrey R Kaiser, MD, MA, FAAP, Milton S. Hershey Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: August 12, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimated): August 14, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: prophylactic; late preterm infant; large for gestational age; neonatal hypoglycemia; dextrose gel; newborn hypoglycemia; small for gestational age
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Body Weight; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Fetal Diseases; Growth Disorders; Diabetes Complications; Diabetes, Gestational; Pregnancy in Diabetics; Birth Weight; Premature Birth; Fetal Growth Retardation; Hypoglycemia; Fetal Macrosomia
• Other Study ID Numbers: H-36132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No