NCT01825473

Study of Erythromycin in GER-Associated Apnea of the Newborn

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 14 Days
• Healthy volunteers: Accepted

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.

Conditions

• Gastroesophageal Reflux
• Apnea
• Bradycardia

Interventions

Type	Name	Description
DRUG	Erythromycin
DEVICE	Multi-channel intra-luminal impedance (MII) pH monitoring
DRUG	Placebo (D5W)

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-03-01
• Completion: 2014-06-01
• First posted: 2013-04-05
• Last updated: 2013-04-05

Locations

1 site across 1 country: United States