Gastro-oesophageal Reflux Disease Trial, Recruiting NCT06534359 Sponsor: Children's Hospital of Philadelphia Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT06534359
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 were born before 32 weeks of pregnancy
  • Babies who are currently between 36 and 65 weeks post-menstrual age (the age calculated from the mother's last period before pregnancy)
  • Babies who have been diagnosed with bronchopulmonary dysplasia (a lung condition affecting premature babies) of a certain severity, or a milder form that has required prolonged breathing support and full tube feeding (confirm with trial site for exact grade details)
  • Babies who are currently receiving breathing support through a high-flow nasal tube, a non-invasive breathing machine, or a ventilator (breathing machine through a tube in the airway)
  • Babies who are receiving all of their nutrition through a stomach feeding tube (at least 100mL per kilogram of body weight per day)
  • A parent or guardian has given consent for the baby to participate

Who may not be able to join:

  • Babies who have received feeding through a tube placed past the stomach (transpyloric feeding) within the last 7 days
  • Babies who have used medications to reduce stomach acid, promote gut movement, or caffeine within the last 7 days
  • Babies who have had a surgical feeding tube placed in the stomach, stomach surgery to prevent reflux, or bowel removal that makes transpyloric feeding unsafe
  • Babies where the medical team plans to reduce or stop breathing support, or remove the breathing tube, within the 2-week study period
  • Babies who are known to have had problems tolerating transpyloric feeding in the past
  • Babies on a breathing tube where more than 20% of the air is leaking around the tube (for ventilated babies only)
  • Babies currently taking part in another clinical trial involving an experimental treatment
  • Babies with a serious birth defect or genetic condition that affects the gut, heart, or lungs

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 28 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

Phone: 267-648-2720

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
Children's Hospital of Philadelphia
Registry
ClinicalTrials.gov
Start date
15 July 2025
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Proportion (%) of time per day with oxygen saturation <80%; Serious adverse events

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: 28 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