Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia

November 16, 2016 updated by: Jeffrey Radin Kaiser, MD, MA, Baylor University
This will be a quasi-experimental study comparing blood glucose values 30 minutes after feeding alone or feeding + 40% dextrose gel in newborns at risk for transient neonatal hypoglycemia.

Study Overview

Detailed Description

BACKGROUND: Low blood sugar in newborns affects about 10% of all deliveries and about 50% of newborns with identified risk factors and is associated with poor long-term neurodevelopmental outcomes. Risk factors for transient neonatal hypoglycemia include infants of diabetic mothers, infants who are large or small for gestational age, infants with intrauterine growth restriction, and late-preterm infants.

GAP: Current standard of care recommends asymptomatic infants to receive intravenous dextrose after becoming hypoglycemic. International studies using dextrose gel have shown that the buccal mucosa is a promising alternative route, normalizes hypoglycemia, and decreases NICU admission. So far, no studies have published results about the efficacy of prophylactic dextrose gel.

HYPOTHESIS: We hypothesize that the prophylactic treatment of newborns at-risk for transient neonatal hypoglycemia with 40% dextrose gel will raise blood sugar levels by 15% compared to untreated controls. We hypothesize that 40% dextrose gel will prevent up to 50% of NICU admissions in this at-risk population compared to matched controls.

METHODS: This will be a quasi-experimental study. The study population will include babies born at Harris Health Ben Taub Hospital and have risk factors for transient neonatal hypoglycemia. After the baby completes its first feed, he or she will be given a dose of oral dextrose gel. A blood sugar level will be checked after 30 minutes, per standard of care. One hundred at-risk infants will be identified and have written parental consent prior to delivery and receiving the prophylactic treatment. Five hundred additional matched controls with similar risk factors will be analyzed for comparison and will not receive treatment.

RESULTS: Pending

IMPACT: If the study proves the hypotheses are correct, prophylactic dextrose gel could be implemented in newborn nurseries around the country to prevent transient hypoglycemia, decrease NICU admission (and its associated costs, painful procedures, and separation from family), improve feeding quality, and potentially optimize neurodevelopmental outcomes.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 hour (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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
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 hours
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.
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeffrey R Kaiser, MD, MS, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

August 12, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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