Pulmonary Hypertension Trial, Recruiting NCT03980717 Sponsor: Michael A Belfort Condition: Pulmonary Hypertension
Back to Pulmonary Hypertension

Pulmonary Hypertension Trial, Recruiting

NCT03980717
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 patient must be a pregnant woman between 18 and 45 years of age
  • The pregnancy must be a single baby (not twins or more)
  • The baby must be between 28 weeks and 31 weeks and 6 days of pregnancy at the time of assessment
  • The baby must have a confirmed severe diagnosis of a condition called congenital diaphragmatic hernia (CDH), where the diaphragm has not developed properly, affecting either the left or right side, with specific measurements showing very small lung volume and a significant portion of the liver pushed into the chest cavity
  • The baby's heart scan must be normal, or show only a minor finding that a specialist heart doctor does not expect to affect the baby's health after birth
  • The baby's chromosome and genetic testing must come back normal
  • The mother must be healthy enough to undergo surgery
  • The patient and the baby's father must sign a consent form that explains the risks of the procedure to both mother and baby
  • The patient must be willing to stay in Houston from the time of the procedure until the baby is born

Who may not be able to join:

  • People for whom abdominal surgery, keyhole surgery on the baby, or general anesthesia is not safe
  • People with a latex allergy
  • People with a known allergy or previous bad reaction to any medication specified in this study
  • People who have preterm labour, a pregnancy-related high blood pressure condition (preeclampsia), or an abnormality of the uterus (such as large fibroid tumours) in this pregnancy
  • Cases where the baby has abnormal chromosomes, known significant genetic variants, other major physical abnormalities that may affect the baby's survival, or a known genetic syndrome
  • Cases where a major recognised syndrome (such as Fryns syndrome) is suspected based on ultrasound or MRI scans
  • People with a body mass index (BMI) over 40
  • Cases where there is a high risk that the baby may have haemophilia

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: Michael Belfort, MD PhD, Baylor College of Medicine

Phone: 832-826-7375

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
Michael A Belfort
Registry
ClinicalTrials.gov
Start date
9 August 2019
Est. completion
1 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Resolution of Pulmonary Hypertension - 6 months; Resolution of Pulmonary Hypertension - 12 months

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