Study of Erythromycin in GER-Associated Apnea of the Newborn — SEGAN  

Gastroesophageal Reflux Clinical Trial

Official title: Study of Erythromycin in GER-Associated Apnea of the Newborn

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 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 investigators will study whether erythromycin decreases GER and GER-associated apnea, bradycardia and/or hypoxia in premature infants. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Bradycardia
• Gastroesophageal Reflux

• NCT number: NCT01825473
• Study type: Interventional
• Source: University of Virginia
• Contact: Fara Davalian, MD
• Phone: 434-924-5428
• Email: Fara.Davalian@virginia.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 2012
• Completion date: June 2014