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Macrolide Antibiotic

Erythromycin for Slow Heart Rate (SEGAN Trial)

N/A
Waitlist Available
Led By Fara Davalian, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any apnea, bradycardia, or desaturation (ABD) event, or Documented symptoms of reflux
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during day 6 to 7 of study treatment
Awards & highlights

SEGAN Trial 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.

Eligible Conditions
  • Slow Heart Rate
  • Acid Reflux
  • Sleep Apnea

SEGAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

SEGAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during day 6 to 7 of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and during day 6 to 7 of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance
Secondary outcome measures
ABD events per Physiologic Monitoring Database
ABD events recorded by nursing

SEGAN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ErythromycinExperimental Treatment2 Interventions
50 mg/kg/day divided every 6 hours oral for 7 days
Group II: PlaceboPlacebo Group2 Interventions
Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erythromycin
FDA approved

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
756 Previous Clinical Trials
1,245,266 Total Patients Enrolled
Fara Davalian, MDPrincipal InvestigatorUniversity of Virginia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Erythromycin in GER-Associated Apnea of the Newborn
Faranek Davalian, MD 2012. "Study of Erythromycin in GER-Associated Apnea of the Newborn". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01825473.
All > Apnea
~3 spots leftby May 2025
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