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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
University of Virginia Children's Hospital
Charlottesville, Virginia, United States
RECRUITINGReflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance
Time frame: during day 6 to 7 of study treatment
ABD events per Physiologic Monitoring Database
Number of apnea, bradycardia, and/or desaturation events (ABD) per computer algorithm developed at University of Virginia
Time frame: during the entire 7 days of treatment
ABD events recorded by nursing
Number of apnea, bradycardia, and/or desaturations (ABD) recorded by bedside nurse
Time frame: during the entire 7 days of treatment
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