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

University of Virginia

Status: Unknown

Conditions: Bradycardia; Apnea; Gastroesophageal Reflux

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01825473

16220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 14+ days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Erythromycin

Experimental group

Description:

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

Treatment:

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

Drug: Erythromycin

Placebo

Placebo Comparator group

Description:

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

Treatment:

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

Drug: Placebo (D5W)