Study of Erythromycin in GER-Associated Apnea of the Newborn

Condition(s) targeted: Gastroesophageal Reflux; Apnea; Bradycardia

Intervention: Erythromycin (Drug); Multi-channel intra-luminal impedance (MII) pH monitoring (Device); Placebo (D5W) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Virginia

Official(s) and/or principal investigator(s):
Fara Davalian, MD, Principal Investigator, Affiliation: University of Virginia

Overall contact:
Fara Davalian, MD, Phone: 434-924-5428, Email: Fara.Davalian@virginia.edu

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.

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

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

Primary outcome: Reflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance

Secondary outcome:

ABD events per Physiologic Monitoring Database

ABD events recorded by nursing

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Fara Davalian, MD, Phone: 434-924-5428, Email: Fara.Davalian@virginia.edu

University of Virginia Children's Hospital, Charlottesville, Virginia 22903, United States; Recruiting
Fara Davalian, MD, Principal Investigator
David A Kaufman, MD, Sub-Investigator

Starting date: September 2012
Last updated: April 2, 2013