Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia

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

Intervention / Treatment
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* Dietary Supplement: 40% Dextrose gel


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Hour

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL<br>Infants at risk for transient neonatal hypoglycemia following standard-of-care. | |
| Active Comparator: Dextrose Gel<br>Infants given 40% Dextrose gel (0.5ml/kg) in the buccal mucosa after their first feed, within the first hour of life. | Dietary Supplement: 40% Dextrose gel<br>* 40% dextrose gel will be rubbed into the hypoglycemic infant's buccal mucosa at a dose of 0.5ml/kg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prophylactic administration of dextrose gel | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small for gestational age, prophylactic, neonatal hypoglycemia, late preterm infant, large for gestational age, dextrose gel, newborn hypoglycemia