Dextrose Gel Does Not Prevent Neonatal Hypoglycemia

NCT02523222 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: H-36132
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

CONTROL

NO INTERVENTION

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

Dextrose Gel

ACTIVE COMPARATOR

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

Interventions

40% Dextrose gel DIETARY_SUPPLEMENT

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

Dextrose Gel

Eligibility Criteria

• Age: 0 Hours - 1 Hour
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Ben Taub Harris Health Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 29605395 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Premature Birth; Fetal Macrosomia; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes, Gestational; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Growth Disorders; Pathologic Processes

Study Officials

• Jeffrey R Kaiser, MD, MA, FAAP

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pilot Study

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 14, 2015
• Study Start: July 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: July 30, 2018
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)