Gastro-oesophageal Reflux Disease Trial, Recruiting NCT05777512 Sponsor: Boston Children's Hospital Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT05777512
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 born before 32 weeks of pregnancy, assessed between 34 and 44 weeks of corrected age (counting from the original due date)
  • Babies who have been on a breathing machine (either through a tube in the airway, or through a mask or nasal prongs) for at least 48 hours at the time of joining the study, with a minimum level of breathing support as specified by the trial team
  • Babies whose ongoing need for breathing support is caused by underdeveloped lungs due to being born early
  • Babies who are already tolerating a certain amount of milk or formula feeds through a tube into the stomach or small intestine (at least 80 ml per kilogram of body weight per day)

Who may not be able to join:

  • Babies who are on breathing support only temporarily for a reason other than premature lungs — for example, while recovering from surgery
  • Babies who have other significant health conditions that also affect their lungs, such as certain heart defects present from birth, or other genetic, structural, or lung conditions
  • Babies who had a concern about a serious bowel condition called necrotising enterocolitis — including having feeds stopped or paused — in the 7 days before the study would begin
  • Babies with known problems with their digestive tract or airway that would affect how they tolerate tube feeding or how feeds are delivered

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

Principal Investigator: Jonathan Levin, MD, Boston Children's Hospital

Phone: 617-355-1900

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
Boston Children's Hospital
Registry
ClinicalTrials.gov
Start date
26 April 2024
Est. completion
1 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in modified respiratory severity score (mRSS); Tracheal Aspirates

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