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Completed

NCT Number: NCT02523222

Dextrose Gel Does Not Prevent Neonatal Hypoglycemia

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.

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Key information

Conditions

Hypoglycemia Birth Weight Body Weight Complication of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Complications Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Fetal Macrosomia Glucose Metabolism Disorders Growth Disorders Infant, Small for Gestational Age Intrauterine Growth Restriction Metabolic Diseases Neonatal Hypoglycemia Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy in Diabetics Premature Birth Premature Birth of Newborn Signs and Symptoms Urogenital Diseases

Age range

0 hour–1 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ben Taub Harris Health Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Prophylactic administration of dextrose gel

    Time frame: 2 hours

    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. Treatment failure of at-risk infants

    Time frame: 4 days

    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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2015
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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