Study of Erythromycin in GER-Associated Apnea of the Newborn
Launched by UNIVERSITY OF VIRGINIA · Apr 2, 2013
Trial Information
Current as of May 13, 2025
Unknown status
Keywords
ClinConnect Summary
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 events. The investigators have two aims: 1) to examine the relationship between GER and apnea, bradycardia, and/or desaturation (ABD) events by simultaneously employing a unique computer algorithm developed at the University of Virginia to measure ABD events and an Multi-channel Intra-luminal Impedance (MII) pH monitoring to measure GER episodes. 2) In a randomized placebo-controlled trial, the ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria: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 Criteria:
- • major central nervous system, gastrointestinal, or complex cardiac anomalies
About University Of Virginia
The University of Virginia (UVA) is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a focus on interdisciplinary collaboration, UVA leverages its extensive resources and expertise in various fields, including medicine, engineering, and public health, to drive cutting-edge studies that address pressing health challenges. The university's clinical trial programs aim to translate scientific discoveries into effective treatments, ensuring the highest standards of ethical practice and participant safety. Through its strong emphasis on community engagement and education, UVA fosters a culture of research that not only contributes to the scientific community but also enhances the well-being of the populations it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charlottesville, Virginia, United States
Patients applied
Trial Officials
Fara Davalian, MD
Principal Investigator
University of Virginia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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