Study of Erythromycin in GER-Associated Apnea of the Newborn

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Erythromycin in GER-Associated Apnea of the Newborn

Conditions
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Gastroesophageal Reflux, Apnea, Bradycardia

Intervention / Treatment
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* Drug: Erythromycin
* Device: Multi-channel intra-luminal impedance (MII) pH monitoring
* Drug: Placebo (D5W)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABD events per Physiologic Monitoring Database | Number of apnea, bradycardia, and/or desaturation events (ABD) per computer algorithm developed at University of Virginia | during the entire 7 days of treatment | 
| ABD events recorded by nursing | Number of apnea, bradycardia, and/or desaturations (ABD) recorded by bedside nurse | during the entire 7 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonate, apnea, preterm, reflux, gastroesophageal reflux, impedance, erythromycin, desaturation, bradycardia, hypoxia