Study of Erythromycin in GER-Associated Apnea of the Newborn (SEGAN)

This study is currently recruiting participants.
Verified April 2013 by University of Virginia
Sponsor:
Information provided by (Responsible Party):
Faranek Davalian, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01825473
First received: March 20, 2013
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux
Apnea
Bradycardia
Drug: Erythromycin
Device: Multi-channel intra-luminal impedance (MII) pH monitoring
Drug: Placebo (D5W)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Erythromycin in GER-Associated Apnea of the Newborn

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ABD events per Physiologic Monitoring Database [ Time Frame: during the entire 7 days of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of apnea, bradycardia, and/or desaturations (ABD) recorded by bedside nurse


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erythromycin
50 mg/kg/day divided every 6 hours oral for 7 days
Drug: Erythromycin Device: Multi-channel intra-luminal impedance (MII) pH monitoring
Other Name: Sandhill 6.5 French, product# ZINBS45E
Placebo Comparator: Placebo
Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days
Device: Multi-channel intra-luminal impedance (MII) pH monitoring
Other Name: Sandhill 6.5 French, product# ZINBS45E
Drug: Placebo (D5W)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01825473

Contacts
Contact: Fara Davalian, MD 434-924-5428 Fara.Davalian@virginia.edu

Locations
United States, Virginia
University of Virginia Children's Hospital Recruiting
Charlottesville, Virginia, United States, 22903
Principal Investigator: Fara Davalian, MD         
Sub-Investigator: David A Kaufman, MD         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Fara Davalian, MD University of Virginia
  More Information

No publications provided

Responsible Party: Faranek Davalian, MD, Neonatology Fellow, University of Virginia
ClinicalTrials.gov Identifier: NCT01825473     History of Changes
Other Study ID Numbers: 16220
Study First Received: March 20, 2013
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
neonate
apnea
preterm
reflux
gastroesophageal reflux
impedance
erythromycin
desaturation
bradycardia
hypoxia

Additional relevant MeSH terms:
Bradycardia
Apnea
Gastroesophageal Reflux
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Erythromycin stearate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 17, 2014