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Study of Erythromycin in GER-Associated Apnea of the Newborn

NCT01825473 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-04-05

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux
  • Apnea
  • Bradycardia

Interventions

DRUG

Erythromycin

DEVICE

Multi-channel intra-luminal impedance (MII) pH monitoring

DRUG

Placebo (D5W)

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Fara Davalian, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-03-31
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01825473 on ClinicalTrials.gov