Comparing treatments for GERD in infants
Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 369 (estimated) |
| Ages | 1 Day to 8 Months |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06114836 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with known lethal chromosomal abnormalities, severe neurologic pathologies, or upper gastrointestinal malformations may not benefit from this study.
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 performed: Other studies have explored treatments for GERD in infants, but this specific comparison of therapies is novel and may provide new insights.
Eligibility criteria
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 this trial is running
Columbus, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.