Prophylactic Dextrose Gel for Newborn Hypoglycemia



Status:Not yet recruiting
Conditions:Women's Studies, Endocrine
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:July 2016
Contact:Sarah M Coors, BSN, DO
Email:smcoors@texaschildrens.org
Phone:832-826-1320

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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.

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. Fifty at-risk infants will be identified and have written parental consent prior to
delivery. Fifty additional matched controls with similar risk factors will be analyzed for
comparison.

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.

Inclusion Criteria:

- Gestational age above 34 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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Jeffrey R Kaiser, MD, MA
Phone: 832-826-3702
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mi
from
Houston, TX
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