Study of Erythromycin in GER-Associated Apnea of the Newborn

Gastroesophageal Reflux Clinical Trial

— SEGAN  

Official title:

Study of Erythromycin in GER-Associated Apnea of the Newborn

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01825473
• Other study ID #: 16220
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2013
• Last updated: April 2, 2013
• Start date: September 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2013
• Source: University of Virginia
• Contact: Fara Davalian, MD
• Phone: 434-924-5428
• Email: Fara.Davalian[@]virginia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Intervention

Drug:
• Erythromycin

Device:
• Multi-channel intra-luminal impedance (MII) pH monitoring

Drug:
• Placebo (D5W)

Locations

Country	Name	City	State
United States	University of Virginia Children's Hospital	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance		during day 6 to 7 of study treatment	No
Secondary	ABD events per Physiologic Monitoring Database	Number of apnea, bradycardia, and/or desaturation events (ABD) per computer algorithm developed at University of Virginia	during the entire 7 days of treatment	No
Secondary	ABD events recorded by nursing	Number of apnea, bradycardia, and/or desaturations (ABD) recorded by bedside nurse	during the entire 7 days of treatment	No