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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: Recruiting NA study of GERD in Infants, sponsored by Nationwide Children's Hospital.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Achievement of the primary outcome will be measured by treatment group to determine efficacy. For subjects on full oral feeds at inception, the primary outcome will be met if there is maintenance of oral feeds AND absence of associated GERD symptoms. For subjects receiving any tube feeding at inception, the primary outcome will be met if there is improvement in oral feeding (ratio of oral to tube feeds) OR absence of troublesome symptoms. The metric for measuring the absence of troublesome sympt
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 |
What NCT06114836 shows while recruiting
NCT06114836 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).
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 a single indexed study location in 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
How this trial's enrollment target compares
Where NCT06114836's enrollment target sits among peer trials
369 281st of 2000 higher than 1,719 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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