SEGAN: Study of Erythromycin in GER-Associated Apnea of the Newborn

Sponsor

University of Virginia (Other)

Overall Status

Unknown status

CT.gov ID

NCT01825473

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Apnea Bradycardia	Drug: Erythromycin Device: Multi-channel intra-luminal impedance (MII) pH monitoring Drug: Placebo (D5W)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Study of Erythromycin in GER-Associated Apnea of the Newborn

Study Start Date :

Sep 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erythromycin 50 mg/kg/day divided every 6 hours oral for 7 days	Drug: Erythromycin Device: Multi-channel intra-luminal impedance (MII) pH monitoring Other Names: Sandhill 6.5 French, product# ZINBS45E
Placebo Comparator: Placebo Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days	Device: Multi-channel intra-luminal impedance (MII) pH monitoring Other Names: Sandhill 6.5 French, product# ZINBS45E Drug: Placebo (D5W)

Arm

Intervention/Treatment

Experimental: Erythromycin

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

Drug: Erythromycin

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

Other Names:

Sandhill 6.5 French, product# ZINBS45E

Placebo Comparator: Placebo

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

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

Other Names:

Sandhill 6.5 French, product# ZINBS45E

Drug: Placebo (D5W)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

ABD events per Physiologic Monitoring Database [during the entire 7 days of treatment]
Number of apnea, bradycardia, and/or desaturation events (ABD) per computer algorithm developed at University of Virginia
ABD events recorded by nursing [during the entire 7 days of treatment]
Number of apnea, bradycardia, and/or desaturations (ABD) recorded by bedside nurse

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Days and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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: