Pulmonary Hypertension Trial, Recruiting NCT06832163 Sponsor: Children's Hospital of Fudan University Condition: Pulmonary Hypertension
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Pulmonary Hypertension Trial, Recruiting

NCT06832163
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:

  • The baby has been given inhaled nitric oxide (a gas used to help with breathing) or is expected to receive it for at least 24 hours, based on a diagnosis of a newborn lung condition called persistent pulmonary hypertension of the newborn (PPHN).
  • The baby has shown a positive response to the inhaled nitric oxide treatment.
  • The device being used to deliver the inhaled nitric oxide meets specific technical requirements set by the trial, including a particular automatic control feature (confirm with trial site).
  • The baby's parent or legal guardian has been fully informed of the possible benefits and risks of the trial and has agreed to take part by signing a consent form.

Who may not be able to join:

  • The baby has certain serious heart conditions, such as severe underdevelopment of the left side of the heart, a heart defect that depends on a specific blood vessel remaining open, life-threatening birth defects affecting the heart, or heart failure.
  • The baby has a rare inherited blood condition called congenital methemoglobinemia, which affects how the blood carries oxygen.
  • The baby has experienced serious bleeding, such as bleeding in or around the brain or in the lungs.
  • The baby has a long-term lung condition or another hard-to-treat illness that would make it unsuitable to begin reducing the inhaled nitric oxide within seven days of starting it.
  • The baby has not shown any response to the inhaled nitric oxide, or has only received it for less than 30 minutes.
  • The starting dose of inhaled nitric oxide was above 20 parts per million, or the planned starting point for reducing the dose is below 20 parts per million (confirm with trial site).
  • The baby is already taking part in another clinical trial involving a different medicine or medical device.
  • The trial doctor has determined that participation in this study would not be appropriate for the baby.

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: Lin Yuan, Children's Hospital of Fudan University

Phone: +86 13601911685

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 Fudan University
Registry
ClinicalTrials.gov
Start date
1 October 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The occurrence of nitric oxide (NO) rebound hypoxia during the evacuation process; The total duration of inhaled nitric oxide (iNO) evacuation

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