- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02523222
Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Ben Taub Harris Health Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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40% dextrose gel will be rubbed into the hypoglycemic infant's buccal mucosa at a dose of 0.5ml/kg.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prophylactic administration of dextrose gel
Time Frame: 2 hours
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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.
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2 hours
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Treatment failure of at-risk infants
Time Frame: 4 days
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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.
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4 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffrey R Kaiser, MD, MS, Baylor College of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Body Weight
- Fetal Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Growth Disorders
- Diabetes, Gestational
- Pregnancy in Diabetics
- Birth Weight
- Hypoglycemia
- Premature Birth
- Fetal Growth Retardation
- Fetal Macrosomia
Other Study ID Numbers
- H-36132
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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