Comparing treatments for GERD in infants
Official title: Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial
Run by Nationwide Children's Hospital · NCT06114836 · Data updated 2026-11-12
This study is testing three different treatments for GERD in infants in the NICU to see which one helps them feed better and feel more comfortable.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 8 Months |
| Sex | All |
| Enrollment | 369 (estimated) |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | March 14, 2024 |
| Main results expected | November 1, 2028 |
| Study ends | November 1, 2028 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT06114836 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are NICU infants aged 37 to 47 weeks postmenstrual age diagnosed with GERD based on pH-impedance criteria.
✕Probably not a fit
Patients with known lethal chromosomal abnormalities, severe neurologic pathologies, or upper gastrointestinal malformations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to evaluate the effectiveness of three different therapies for treating gastroesophageal reflux disease (GERD) in infants in the NICU. The study involves a randomized controlled design where infants will receive either natural maturation, proton pump inhibitors (PPIs), or added rice formula for four weeks. The primary goal is to assess oral feeding success and the absence of troublesome symptoms, with outcomes measured using pH-impedance testing. A second pH-impedance test will be conducted at the end of the treatment period or before discharge to determine the efficacy of the interventions.
Why it matters
Potential benefit: If successful, this study could provide evidence-based treatment options for managing GERD in infants, improving their feeding success and quality of life.
How similar studies have gone: Other studies have explored treatments for GERD in infants, but this specific comparison of therapies is novel and may provide new insights.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Nationwide Children's Hospita
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Sudarshan R sudarshan.jadcherla@nationwidechildrens.org — Nationwide Children's Hospital
- Study coordinator: Erika K Osborn
- Email: erika.osborn@nationwidechildrens.org
- Phone: 6143556667
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Transauricular Neurostimulation for Abdominal Pain in Teens
We are testing a head- and ear‑based device to see if it helps teens with abdominal pain from gut-brain disorders.
-
MedMemos: helping families stick to medications after pediatric stem cell transplant
MedMemos tests a caregiver-focused program to help families of children who had a bone marrow transplant take medications more consistently.
-
Light therapy for children in the pediatric ICU
This project will try daily bedside light therapy for children aged 4–17 in the pediatric ICU to see how easy it is to deliver and whether patients, families, and staff tolerate it.
-
Food is Medicine program to boost family heart health
The trial tests whether providing healthy food access plus personalized digital tools and coaching can improve heart health for families with a parent on Medicaid and a 6–11 year old child.
-
AI-based personalized health and self-care support for caregivers of children
This pilot will test whether the DAPHNE chatbot helps caregivers of children with unmet social needs connect to community resources, stay engaged, and fit into primary care workflows over six months.
-
Caregiver questionnaire on firearm ownership and safety
We will ask parents and legal guardians of children having surgery at Nationwide Children's Hospital about firearm ownership, storage, access, and safety education to see if common safety practices are followed.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.