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NCT02486263 · ClinicalTrials.gov registry record · NA
Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial
A NA study, sponsored by Sudarshan Jadcherla.
- Completed
- Registry status
- NA
- Development phase
- 76
- Enrollment target
NCT02486263: Completed NA study, sponsored by Sudarshan Jadcherla.
NCT02486263 is a NA study that has completed, run by Sudarshan Jadcherla. The registered enrollment target is 76 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02486263, a NA study, has completed, sponsored by Sudarshan Jadcherla.
- COMPLETED
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
Study 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.
Primary Outcome
The primary endpoint is the feeding success defined as achieving full oral feeds (defined as no need for tube feeds to maintain hydration and nutrition) and/or a \>/= 6 point decrease from baseline symptom score as described by the Infant-Gastro-Esophageal Reflux Questionnaire-Revised. The minimum score is 0 (no symptoms) and the maximum score is 42 (maximum symptoms). Any total score greater than or equal to 16 is considered abnormal.
Interventions
- OTHER Study Arm - acid suppression plus feeding bundle
- OTHER Conventional arm - acid suppression only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2012-12 |
| Est. Completion | 2020-03-31 |
| Phase | NA |
What the finished NCT02486263 record still lists
NCT02486263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Study Arm - acid suppression plus feeding bundle is the first listed.
NCT02486263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02486263 about?
NCT02486263 is a clinical study titled "Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial". 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 s...
What is the current status of trial NCT02486263?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2012-12. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT02486263?
The interventions under investigation include: Study Arm - acid suppression plus feeding bundle (OTHER), Conventional arm - acid suppression only (OTHER).
Who is sponsoring clinical trial NCT02486263?
This trial is sponsored by Sudarshan Jadcherla, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02486263's enrollment target sits among peer trials
76 1062nd of 2000 higher than 932 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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