Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06114836 · ClinicalTrials.gov registry record · NA
GERD Infant Feeding Therapeutics Trial (GIFT Trial)
A NA study of GERD in Infants, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 369
- Enrollment target
- 1
- Study location
NCT06114836 is a NA study of GERD in Infants that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 369 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06114836, a NA study of GERD in Infants, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 369 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this investigator-initiated, single-center, randomized controlled trial (RCT) is to compare the effects of four weeks of three therapies on clinical and mechanistic outcomes based on pH-Imp testing using a three-arm parallel design in NICU infants with objective GERD diagnosis. The three therapies being compared are natural maturation, proton pump inhibitor (PPI) use, and added rice (AR) formula use. The main goals are: * to evaluate and compare the efficacy of the three commonly used treatment interventions used in the NICU for GERD in a randomized controlled manner with the primary endpoint of oral feeding success and absence of troublesome symptoms (as defined below). * to characterize the mechanisms of primary end point (success or failure) using pH-Impedance metrics.
Conditions Studied
Interventions
- DRUG Omeprazole
- OTHER AR formula
Study Locations (1)
Ohio
- Nationwide Children's Hospita - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2024-03-14 |
| Est. Completion | 2028-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06114836
The ClinicalTrials.gov registry entry for NCT06114836 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 369 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with GERD in Infants appearing as the primary indexed condition, and to 2 interventions - of which Omeprazole is the first listed.
NCT06114836 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06114836 about?
NCT06114836 is a clinical study titled "GERD Infant Feeding Therapeutics Trial (GIFT Trial)". The goal of this investigator-initiated, single-center, randomized controlled trial (RCT) is to compare the effects of four weeks of three therapies on clinical and mechanistic outcomes based on pH-Imp testing using a three-arm parallel design in NICU infants with objective GERD diagnosis. The three...
What is the current status of trial NCT06114836?
This trial is currently recruiting. It is a NA study. The enrollment target is 369 participants. The study started on 2024-03-14. Estimated completion is 2028-11.
What conditions does trial NCT06114836 study?
This clinical trial studies the following conditions: GERD in Infants.
What interventions are being tested in trial NCT06114836?
The interventions under investigation include: Omeprazole (DRUG), AR formula (OTHER).
Who is sponsoring clinical trial NCT06114836?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06114836 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.