EFFICACY AND COMPARISON OF TWO COMMONLY USED DOSES OF BETHANECHOL IN THE MANAGEMENT OF INFANT GASTROESOPHAGEAL REFLUX IN NEONATAL INTENSIVE CARE UNIT
EFFICACY AND COMPARISON OF TWO COMMONLY USED DOSES OF BETHANECHOL IN THE MANAGEMENT OF INFANT GASTROESOPHAGEAL REFLUX IN NEONATAL INTENSIVE CARE UNIT
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Clinical Trial Information
Trial Contact: Winbigler, Holly M; Roppo, Emily; Wills, Caitlin C
Trial Phone: 321.841.3938 ; 321.842.7567 ; 3218419560
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IRB No: 23.125.06
Protocol Abbrev: NICU Bethanechol
Principal Investigator: Devendra I Mehta, MD
Age Group: Neonate
Treatment: Bethanechol
Therapies Involved: Medication
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Objective
To identify which of the currently used dose options of bethanechol is optimal by assessing its efficacy on the MII-pH parameters (acid reflux index, number of acid refluxes, total acidic reflux time, long refluxes; number of non-acid refluxes, liquid refluxes, mixed refluxes, extent of refluxes in the 6 impedance probes, esophageal acid clearance time and symptom scores)
To monitor if lower dose of bethanechol had to be increased during follow up after 2 weeks of treatment and to monitor potential side effects of bethanechol -
Key Eligibility
• Patients aged between postnatal age of 4 weeks to <1 year old in the Neonatal Intensive Care Unit.
• Patients who have never been on Bethanechol or who have been off Bethanechol for at least 2 weeks prior will be included in the study.
• Patients with total number of refluxes > 71 at 24 hours study analysis
