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Macrolide Antibiotic

Study of Erythromycin in GER-Associated Apnea of the Newborn (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 the entire 7 days of treatment
Awards & highlights
All Individual Drugs Already Approved
Approved for 70 Other Conditions

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
  • Gastroesophageal Reflux Disease
  • Home Sleep Apnea Test
  • Slow Heart Rate
  • Apnea
  • Acid Reflux

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the entire 7 days of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the entire 7 days of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
ABD events per Physiologic Monitoring Database
ABD events recorded by nursing

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 70 Other Conditions
This treatment demonstrated efficacy for 70 other conditions.

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
785 Previous Clinical Trials
1,316,406 Total Patients Enrolled
Fara Davalian, MDPrincipal InvestigatorUniversity of Virginia
~3 spots leftby Jan 2026
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