Study of Erythromycin in GER-Associated Apnea of the Newborn
| Status: | Completed |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Cardiology, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2012 |
| End Date: | June 2014 |
| Contact: | Fara Davalian, MD |
| Email: | Fara.Davalian@virginia.edu |
| Phone: | 434-924-5428 |
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.
of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or
desaturation events in a prospective randomized controlled trial.
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.
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.
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
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