Pulmonary Hypertension Trial, Recruiting NCT05636397 Sponsor: The Hospital for Sick Children Condition: Pulmonary Hypertension
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Pulmonary Hypertension Trial, Recruiting

NCT05636397
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:

Group 1 – Babies with lung disease and/or high blood pressure in the lungs (BPD±PH):

  • The baby was born at 30 weeks of pregnancy or earlier
  • The baby has reached at least 32 weeks of corrected age (counting from the original due date)
  • For babies who also have high blood pressure in the lungs, an ultrasound of the heart must show evidence of this condition
  • The baby needs breathing support (through a tube or a mask/device) for more than 12 hours a day, for at least 2 days, at a level above a certain threshold (confirm with trial site)
  • A parent or legal guardian has given written consent to participate

Group 2 – Babies recovering from a serious bowel condition requiring surgery (surgical NEC):

  • The baby was born at 30 weeks of pregnancy or earlier
  • The baby is recovering from a severe form of a bowel condition called NEC, which required surgery
  • The baby is able to tolerate a small amount of milk or feeding through the gut each day
  • The baby is considered medically stable by their care team
  • A parent or legal guardian has given written consent to participate

Who may not be able to join:

Group 1:

  • The baby has a significant heart defect present from birth (small holes in the heart or a small open vessel near the heart may be allowed — confirm with trial site)
  • The baby has a narrowing of the veins that carry blood from the lungs to the heart
  • The baby currently has a serious infection that is affecting their blood pressure and circulation
  • The baby is not expected to survive the next 7 days
  • The baby has any other condition that the doctor feels could put them at risk or affect their ability to take part in the study

Group 2:

  • The baby has a significant heart defect present from birth (small holes in the heart may be allowed — confirm with trial site)
  • The baby has a narrowing of the veins that carry blood from the lungs to the heart
  • The baby currently has a serious infection that is affecting their blood pressure and circulation
  • The baby is not expected to survive the next 7 days
  • The baby has another condition (unrelated to being born early or the bowel condition) that is significantly affecting how their lungs work

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 27 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: Estelle Gauda, MD, Division Head, Division of Neonatology

Phone: +1(416)-813-7654

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
The Hospital for Sick Children
Registry
ClinicalTrials.gov
Start date
1 November 2023
Est. completion
1 December 2027

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Safety of oral L-Citrulline administration

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: 27 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