Gastroesophageal Reflux, Apnea, Bradycardia
Conditions
Keywords
neonate, apnea, preterm, reflux, gastroesophageal reflux, impedance, erythromycin, desaturation, bradycardia, hypoxia
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.
Interventions
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Days to No maximum
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: * Any apnea, bradycardia, or desaturation (ABD) event, or * Documented symptoms of reflux
Exclusion criteria
* major central nervous system, gastrointestinal, or complex cardiac anomalies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactFara Davalian, MD
Outcome results
None listed