Overview
Study of Erythromycin in GER-Associated Apnea of the Newborn
Status:
Unknown status
Unknown status
Trial end date:
2014-06-01
2014-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To evaluate the relationship of reflux and apnea and to determine whether the administration of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or desaturation events in a prospective randomized controlled trial.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
University of VirginiaTreatments:
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Phenobarbital
Criteria
Inclusion Criteria:Infants admitted to neonatal intensive care unit who are <37 weeks atbirth and >14 days of age, non-intubated, on full feeds for 3 days with one of the
following:
- Any apnea, bradycardia, or desaturation (ABD) event, or
- Documented symptoms of reflux
Exclusion Criteria:
- major central nervous system, gastrointestinal, or complex cardiac anomalies