Status:
UNKNOWN
Study of Erythromycin in GER-Associated Apnea of the Newborn
Lead Sponsor:
University of Virginia
Conditions:
Gastroesophageal Reflux
Apnea
Eligibility:
All Genders
14+ years
Phase:
NA
Brief 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 eve...
Detailed Description
A randomized placebo-controlled trial to determine whether erythromycin, a drug known to enhance gut motility, will improve the incidence of GER and GER-associated apnea, bradycardiac and/or hypoxic e...
Eligibility Criteria
Inclusion
- Infants admitted to neonatal intensive care unit who are \<37 weeks at birth 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
- major central nervous system, gastrointestinal, or complex cardiac anomalies
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01825473
Start Date
September 1 2012
End Date
June 1 2014
Last Update
April 5 2013
Active Locations (1)
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1
University of Virginia Children's Hospital
Charlottesville, Virginia, United States, 22903