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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythromycin | Experimental | 50 mg/kg/day divided every 6 hours oral for 7 days |
|
| Placebo | Placebo Comparator | Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythromycin | Drug |
| ||
| Multi-channel intra-luminal impedance (MII) pH monitoring |
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fara Davalian, MD | Contact | 434-924-5428 | Fara.Davalian@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Fara Davalian, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Children's Hospital | Recruiting | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D001049 | Apnea |
| D001919 | Bradycardia |
| D047928 | Premature Birth |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D004917 | Erythromycin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Device |
|
|
| Placebo (D5W) | Drug |
|
Number of apnea, bradycardia, and/or desaturations (ABD) recorded by bedside nurse
| during the entire 7 days of treatment |
| D004066 | Digestive System Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |