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Dextrose Gel Does Not Prevent Neonatal Hypoglycemia

NCT02523222 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2025-01-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Jeffrey R Kaiser, MD, MA, FAAP · Milton S. Hershey Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Hours
Max Age
1 Hour
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2018-03-01
Completion
2018-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02523222 on ClinicalTrials.gov