Dextrose Gel Does Not Prevent Neonatal Hypoglycemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2018-07-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Pilot Study

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CONTROL

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Dextrose Gel

Infants given 40% Dextrose gel (0.5ml/kg) in the buccal mucosa after their first feed, within the first hour of life.

Group Type ACTIVE_COMPARATOR

40% Dextrose gel

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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40% Dextrose gel

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

0 Hours

Maximum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

No