Study of Erythromycin in GER-Associated Apnea of the Newborn

NCT01825473 | Unknown

• 1 other identifier: 16220
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Reflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance

  during day 6 to 7 of study treatment

Secondary Outcomes (2)

• ABD events per Physiologic Monitoring Database

  during the entire 7 days of treatment

• ABD events recorded by nursing

  during the entire 7 days of treatment

Study Arms (2)

Erythromycin

EXPERIMENTAL

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

Drug: Erythromycin; Device: Multi-channel intra-luminal impedance (MII) pH monitoring

Placebo

PLACEBO COMPARATOR

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

Device: Multi-channel intra-luminal impedance (MII) pH monitoring; Drug: Placebo (D5W)

Interventions

Erythromycin DRUG

Erythromycin

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

Also known as: Sandhill 6.5 French, product# ZINBS45E

Erythromycin; Placebo

Placebo (D5W) DRUG

Placebo

Eligibility Criteria

• Age: 14 Days+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• major central nervous system, gastrointestinal, or complex cardiac anomalies

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Children's Hospital

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Apnea; Bradycardia; Premature Birth; Hypoxia

Interventions

Erythromycin

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Fara Davalian, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fara Davalian, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatology Fellow

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: April 5, 2013
• Study Start: September 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 5, 2013

Record last verified: 2013-04

Locations

US (1)