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

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ClinicalTrials.gov Identifier: NCT01825473
Recruitment Status : Unknown
Verified April 2013 by Faranek Davalian, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : April 5, 2013
Last Update Posted : April 5, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Apnea Bradycardia Drug: Erythromycin Device: Multi-channel intra-luminal impedance (MII) pH monitoring 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Erythromycin in GER-Associated Apnea of the Newborn
Study Start Date : September 2012
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Faranek Davalian, MD, Neonatology Fellow, University of Virginia
ClinicalTrials.gov Identifier: NCT01825473     History of Changes
Other Study ID Numbers: 16220
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Apnea
Gastroesophageal Reflux
Bradycardia
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
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action