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Study of Erythromycin in GER-Associated Apnea of the Newborn (SEGAN)

Primary Purpose

Gastroesophageal Reflux, Apnea, Bradycardia

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Erythromycin

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

Placebo (D5W)

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring neonate, apnea, preterm, reflux, gastroesophageal reflux, impedance, erythromycin, desaturation, bradycardia, hypoxia

Eligibility Criteria

14 Days - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Virginia Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Erythromycin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ABD events per Physiologic Monitoring Database

Number of apnea, bradycardia, and/or desaturation events (ABD) per computer algorithm developed at University of Virginia

ABD events recorded by nursing

Number of apnea, bradycardia, and/or desaturations (ABD) recorded by bedside nurse

Full Information

NCT ID

NCT01825473

First Posted

March 20, 2013

Last Updated

April 2, 2013

Sponsor

University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT01825473

Brief Title

Study of Erythromycin in GER-Associated Apnea of the Newborn

Acronym

SEGAN

Official Title

Study of Erythromycin in GER-Associated Apnea of the Newborn

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux, Apnea, Bradycardia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Erythromycin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Erythromycin

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

Sandhill 6.5 French, product# ZINBS45E

Intervention Type

Drug

Intervention Name(s)

Placebo (D5W)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

ABD events per Physiologic Monitoring Database

Description

Number of apnea, bradycardia, and/or desaturation events (ABD) per computer algorithm developed at University of Virginia

Time Frame

during the entire 7 days of treatment

Title

ABD events recorded by nursing

Description

Number of apnea, bradycardia, and/or desaturations (ABD) recorded by bedside nurse

Time Frame

during the entire 7 days of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fara Davalian, MD

Phone

434-924-5428

Fara.Davalian@virginia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fara Davalian, MD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia Children's Hospital

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fara Davalian, MD

First Name & Middle Initial & Last Name & Degree

David A Kaufman, MD

12. IPD Sharing Statement

Learn more about this trial

Study of Erythromycin in GER-Associated Apnea of the Newborn

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