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Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial

NCT02486263 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2020-07-29

Study results available
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Summary

The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Many infants have GERD and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. Some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most GERD treatments are done based on experience, but there is no scientific proof that these methods work for infants. GERD and feeding difficulties can lead to longer hospitalization and more stress for the family.

In this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving GERD and GERD complications.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

OTHER

Study Arm - acid suppression plus feeding bundle

* Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID) * Total fluid volume restriction (120-140 milliliters/kilogram/day) * Feeding duration over 30 minutes * Infant feeds with right side down * Infant is placed on back following feeds

OTHER

Conventional arm - acid suppression only

-Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Ohio State University

    collaborator OTHER

  • Sudarshan Jadcherla

    lead OTHER

Principal Investigators

  • Sudarshan R Jadcherla, MD · The Research Institute at Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
34 Weeks
Max Age
60 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02486263 on ClinicalTrials.gov