Gastro-oesophageal Reflux Disease Trial, Recruiting NCT06114836 Sponsor: Nationwide Children's Hospital Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT06114836
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Babies who are currently in a neonatal intensive care unit (NICU) and are between 37 and 47 weeks of postmenstrual age (this is the baby's age calculated from the mother's last menstrual period) at the time the study begins
  • Babies who have been diagnosed with gastroesophageal reflux disease (GERD — a condition where stomach contents flow back up into the food pipe) confirmed by a specific monitoring test measuring acid and fluid movement in the food pipe
  • Babies who are receiving all of their nutrition through feeding (no IV nutrition)
  • Babies who are not currently receiving any treatments for GERD

Who may not be able to join:

  • Babies who have a known serious chromosomal condition or complex birth syndrome
  • Babies who have severe brain or nervous system problems that require brain surgery or medications that affect the nervous system
  • Babies who require breathing support through a mask or device, or who need oxygen delivered at more than 4 litres per minute
  • Babies who have malformations of the upper digestive tract that require surgery

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Sudarshan R sudarshan.jadcherla@nationwidechildrens.org, Nationwide Children's Hospital

Phone: 6143556667

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Nationwide Children's Hospital
Registry
ClinicalTrials.gov
Start date
14 March 2024
Est. completion
1 November 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception); Decrease in ARI on treatment; Decreased frequency of GER events on treatment; Improvement (Increase) in distal baseline impedance on treatment; Decrease in symptom associated probability on treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov