Study of Erythromycin in GER-Associated Apnea of the Newborn

Not Applicable

• Conditions: Gastroesophageal Reflux; Apnea; Bradycardia
• Interventions: Drug: Erythromycin; Device: Multi-channel intra-luminal impedance (MII) pH monitoring; Drug: Placebo (D5W)

• Registration Number: NCT01825473
• Lead Sponsor: University of Virginia

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 events in a prospective randomized controlled trial.

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 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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-20
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-02
• Last Update Submitted: 2013-04-02
• Study First Posted: 2013-04-05
• Last Update Posted: 2013-04-05
• Primary Completion: 2014-03
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erythromycin	Erythromycin	50 mg/kg/day divided every 6 hours oral for 7 days
Erythromycin	Multi-channel intra-luminal impedance (MII) pH monitoring	50 mg/kg/day divided every 6 hours oral for 7 days
Placebo	Multi-channel intra-luminal impedance (MII) pH monitoring	Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days
Placebo	Placebo (D5W)	Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days

Primary Outcome Measures

Name	Time	Method
Reflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance	during day 6 to 7 of study treatment

Secondary Outcome Measures

Name	Time	Method
ABD events per Physiologic Monitoring Database	during the entire 7 days of treatment	Number of apnea, bradycardia, and/or desaturation events (ABD) per computer algorithm developed at University of Virginia
ABD events recorded by nursing	during the entire 7 days of treatment	Number of apnea, bradycardia, and/or desaturations (ABD) recorded by bedside nurse

Trial Locations

Locations (1)

University of Virginia Children's Hospital; 🇺🇸 Charlottesville, Virginia, United States