NCT06114836 GERD Infant Feeding Therapeutics Trial (GIFT Trial)
| NCT ID | NCT06114836 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nationwide Children's Hospital |
| Condition | GERD in Infants |
| Study Type | INTERVENTIONAL |
| Enrollment | 369 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 369 participants in total. It began in 2024-03-14 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * NICU infants of any gestational age who are between 37 - 47 weeks postmenstrual age at inception of the study meeting the following requirements: * GERD diagnosis using pH-impedance criteria (Acid Reflux Index ≥ 3% plus at least one of the following: # GER events \>70 / day, Symptom Associated Probability ≥ 95%, Discal Baseline Impedance \< 900 Ω) * Full enteral feeds * No current GERD therapies Exclusion Criteria: * Known lethal chromosomal abnormalities or complex congenital syndromes * Severe neurologic pathologies requiring neuroactive medications or neurosurgery * Positive airway pressure or oxygen flow \> 4 LPM * Upper gastrointestinal malformations requiring surgery
Contact & Investigator
Sudarshan R sudarshan.jadcherla@nationwidechildrens.org
PRINCIPAL INVESTIGATOR
Nationwide Children's Hospital
Frequently Asked Questions
Who can join the NCT06114836 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 8 Months, studying GERD in Infants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06114836 currently recruiting?
Yes, NCT06114836 is actively recruiting participants. Contact the research team at erika.osborn@nationwidechildrens.org for enrollment information.
Where is the NCT06114836 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06114836 clinical trial?
NCT06114836 is sponsored by Nationwide Children's Hospital. The principal investigator is Sudarshan R sudarshan.jadcherla@nationwidechildrens.org at Nationwide Children's Hospital. The trial plans to enroll 369 participants.