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

April 2, 2013 updated by: Faranek Davalian, MD, University of Virginia
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • Sandhill 6.5 French, product# ZINBS45E
PLACEBO_COMPARATOR: Placebo
Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days
Drug: Placebo (D5W)
Device: Multi-channel intra-luminal impedance (MII) pH monitoring
Other Names:
  • Sandhill 6.5 French, product# ZINBS45E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
during day 6 to 7 of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during the entire 7 days of treatment
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
during the entire 7 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Fara Davalian, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ANTICIPATED)

March 1, 2014

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (ESTIMATE)

April 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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