GERD in InfantsGIFTNCT06114836
GERD Infant Feeding Therapeutics Trial (GIFT Trial)
A study testing Omeprazole and AR formula in people with GERD in Infants, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 8 months
- Conditions the study is for
- GERD in Infants
- What is being tested?
- Omeprazole and AR formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2024to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospita
Columbus, Ohio, 43215
Erika K Osborn, 6143556667, erika.osborn@nationwidechildrens.org
About this study
Official title: Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled 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 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.
Read the detailed description
In consented subjects, eligibility is determined after initial diagnostic 24-hour pH Impedance test. These subjects will be randomized to one of the 3 arms of the study (natural maturation, PPI, AR formula) for 4 weeks of treatment. A second 24-hour pH Impedance test will be done on therapy at 4 weeks or before discharge, whichever occurs first. Primary outcome will also be measured at 4 weeks or at discharge, whichever comes first.
- Conditions
- GERD in Infants
- Being tested
- Omeprazole, AR formula
- Keywords
- Proton Pump Inhibitor, pH Impedance, added rice formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called PPI
Omeprazole will be the PPI prescribed for 4 weeks.
AR formulaOther
Added rice formula will be ordered for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Natural maturation | No intervention | Allows for time for infant maturation without treatment. |
| Proton Pump Inhibitor (PPI) | Active comparator | Omeprazole will be prescribed for 4 weeks using the dose of 1.5mg/kg/dose daily. Receives: Drug: Omeprazole |
| Added Rice (AR) Formula | Active comparator | Added rice formula will be ordered as the infant diet for the 4-week treatment period. Receives: Other: AR formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception)
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 symptoms will be vomiting <2 times/day or coughing <18 times/day.
Measured: At 4 weeks of therapy or discharge, whichever occurs first
Decrease in ARI on treatment
Change in acid reflux index from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Measured: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Decreased frequency of GER events on treatment
Change in number of reflux events from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Measured: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Improvement (Increase) in distal baseline impedance on treatment
Change in distal baseline impedance from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Measured: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Decrease in symptom associated probability on treatment
Change in symptom associated probability from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Measured: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start14 Mar 2024
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GERD in InfantsStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infants will be randomized to one of three arms: Natural maturation, Proton Pump Inhibitor (PPI) treatment, or Added rice (AR) formula. Subjects will be stratified and allocated 1:1:1 based on tube feeds (yes or no) and ARI (3-7% or \>7%).
- Masking
- None (open label)
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudarshan Jadcherla, Nationwide Children's Hospital
- Investigators
- Sudarshan R sudarshan.jadcherla@nationwidechildrens.org, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114836
- Sponsor's protocol ID
- STUDY00003300
- Other IDs
- 1R01DK136762-01
- Acronym
- GIFT
- Status last verified
- Jun 2026
- First submitted
- 26 Oct 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will revisit at a later date
Publications
Jadcherla SR, Osborn EK, Sultana Z, Helmick R, Sanchez JB, Slaughter JL, Wei L, Di Lorenzo C. GERD management in neonatal ICU infants: study protocol for a randomized controlled trial comparing maturation, added rice starch formula and proton pump inhibitors. BMC Pediatr. 2026 Jun 11. doi: 10.1186/s12887-026-07120-x. Online ahead of print.
PubMed 42277732
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06114836
- Acronym / sponsor ID
- GIFT / STUDY00003300
- Conditions
- GERD in Infants
- Keywords
- Proton Pump Inhibitor, pH Impedance, added rice formula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In consented subjects, eligibility is determined after initial diagnostic 24-hour pH Impedance test. These subjects will be randomized to one of the 3 arms of the study (natural maturation, PPI, AR formula) for 4 weeks of treatment. A second 24-hour pH Impedance test will be done on therapy at 4 weeks or before discharge, whichever occurs first. Primary outcome will also be measured at 4 weeks or at discharge, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Infants will be randomized to one of three arms: Natural maturation, Proton Pump Inhibitor (PPI) treatment, or Added rice (AR) formula. Subjects will be stratified and allocated 1:1:1 based on tube feeds (yes or no) and ARI (3-7% or >7%).
| Arm | Type | Receives |
|---|---|---|
| Natural maturation | No intervention | –Allows for time for infant maturation without treatment. |
| Proton Pump Inhibitor (PPI) | Active comparator | Drug: OmeprazoleOmeprazole will be prescribed for 4 weeks using the dose of 1.5mg/kg/dose daily. |
| Added Rice (AR) Formula | Active comparator | Other: AR formulaAdded rice formula will be ordered as the infant diet for the 4-week treatment period. |
Who may qualify
- Ages
- 1 day to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- NICU infants of any gestational age who are between 37 - 47 weeks postmenstrual age at inception of the study meeting the following requirements:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: PPIOmeprazole will be the PPI prescribed for 4 weeks. | Drug | Proton Pump Inhibitor (PPI) |
| AR formulaAdded rice formula will be ordered for 4 weeks. | Other | Added Rice (AR) Formula |
Primary outcome
Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception)
Time frame: At 4 weeks of therapy or discharge, whichever occurs first
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 symptoms will be vomiting <2 times/day or coughing <18 times/day.
Decrease in ARI on treatment
Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Change in acid reflux index from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Decreased frequency of GER events on treatment
Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Change in number of reflux events from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Improvement (Increase) in distal baseline impedance on treatment
Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Change in distal baseline impedance from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Decrease in symptom associated probability on treatment
Time frame: At time 2 study (4 weeks or prior to discharge, whichever is earliest)
Change in symptom associated probability from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 42277732Jadcherla SR, Osborn EK, Sultana Z, Helmick R, Sanchez JB, Slaughter JL, Wei L, Di Lorenzo C. GERD management in neonatal ICU infants: study protocol for a randomized controlled trial comparing maturation, added rice starch formula and proton pump inhibitors. BMC Pediatr. 2026 Jun 11. doi: 10.1186/s12887-026-07120-x. Online ahead of print.
- Individual participant dataSharing planned: No. Will revisit at a later date
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sudarshan R sudarshan.jadcherla@nationwidechildrens.org principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omeprazole and AR formula in people with GERD in Infants, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika K Osborn (6143556667, erika.osborn@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception) (time frame: At 4 weeks of therapy or discharge, whichever occurs first). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06114836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.