An interventional study of Erythromycin and Multi-channel intra-luminal impedance (MII) pH monitoring in Gastroesophageal Reflux, Apnea and Bradycardia, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 14 Days and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-05.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
50 mg/kg/day divided every 6 hours oral for 7 days
Drug: Erythromycin · Device: Multi-channel intra-luminal impedance (MII) pH monitoring
Dextrose 5 Water (D5W) equal amount as experimental every 6 hours oral for 7 days
Device: Multi-channel intra-luminal impedance (MII) pH monitoring · Drug: Placebo (D5W)
Also known as: Sandhill 6.5 French, product# ZINBS45E
Reflux 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
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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University of Virginia