Study of Erythromycin in GER-Associated Apnea of the Newborn

NCT ID: NCT01825473

Last Updated: 2013-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Apnea Bradycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Erythromycin

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

Group Type EXPERIMENTAL

Erythromycin

Intervention Type DRUG

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

Intervention Type DEVICE

Placebo

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type DEVICE

Placebo (D5W)

Intervention Type DRUG

Interventions

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Erythromycin

Intervention Type DRUG

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

Intervention Type DEVICE

Placebo (D5W)

Intervention Type DRUG

Other Intervention Names

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Sandhill 6.5 French, product# ZINBS45E

Eligibility Criteria

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Inclusion Criteria

* Any apnea, bradycardia, or desaturation (ABD) event, or
* Documented symptoms of reflux

Exclusion Criteria

* major central nervous system, gastrointestinal, or complex cardiac anomalies
Minimum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Faranek Davalian, MD

Neonatology Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fara Davalian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia Children's Hospital

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Fara Davalian, MD

Role: CONTACT

434-924-5428

Other Identifiers

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16220

Identifier Type: -

Identifier Source: org_study_id

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