Recruiting

Erythromycin

Sponsor:

University of Virginia

Code:

NCT01825473

Conditions

Gastroesophageal Reflux

Apnea

Bradycardia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Erythromycin

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

Placebo (D5W)

Study Details

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.

Conditions

Gastroesophageal Reflux

Apnea

Bradycardia

Study ID

NCT01825473

Start date

Sep, 2012

Status verified date

Apr, 2013

Completion date

Jun, 2014

Anticipated

Primary completion date

Mar, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Erythromycin

50 mg/kg/day divided every 6 hours oral for 7 days

placebo comparator: Placebo

Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days

Interventions

Erythromycin

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

Placebo (D5W)

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Fara Davalian, MD

434-924-5428Fara.Davalian@virginia.edu

Locations

University of Virginia Children's Hospital

Recruiting

Charlottesville, Virginia, United States, 22903

Principal Investigator:

Fara Davalian, MD

More Information

Sponsor

University of Virginia

Last update posted

Apr 5, 2013

Last verified

Apr, 2013

Keywords

  • neonate
  • apnea
  • preterm
  • reflux
  • gastroesophageal reflux
  • impedance
  • erythromycin
  • desaturation
  • bradycardia
  • hypoxia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2013-04-05.