Study of Erythromycin in GER-Associated Apnea of the Newborn

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2014

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Erythromycin
    • 50 mg/kg/day divided every 6 hours oral for 7 days
  • Placebo Comparator: Placebo
    • Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • ABD events per Physiologic Monitoring Database
    • Time Frame: 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
    • Time Frame: during the entire 7 days of treatment
    • Number of apnea, bradycardia, and/or desaturations (ABD) recorded by bedside nurse

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Virginia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Faranek Davalian, MD, Neonatology Fellow – University of Virginia
  • Overall Official(s)
    • Fara Davalian, MD, Principal Investigator, University of Virginia
  • Overall Contact(s)
    • Fara Davalian, MD, 434-924-5428, Fara.Davalian@virginia.edu

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