Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia

Hypoglycemia Clinical Trial

Official title:

Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523222
• Other study ID #: H-36132
• Status: Completed
• Phase: N/A
• First received: August 12, 2015
• Last updated: November 16, 2016
• Start date: July 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Baylor University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Hour

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Ben Taub Harris Health Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No