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Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Month to 5 Months
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 week

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Following 1week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether different amounts of extra oxygen improve health in babies born very early. It is for babies with pulmonary hypertension, or high blood pressure in the lungs, who need extra oxygen.

Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Born between 22 weeks, 0 days and 31 weeks, 6 days of pregnancy.
  • Have high blood pressure in the lungs shown by a heart ultrasound. At least one finding is needed: more than 20% of blood flow through a vessel called the PDA goes from the lung artery toward the body; the wall between the heart's lower chambers is flattened (a measurement above 1.3); or estimated pressure in the heart's lower right chamber is at least 35 mm Hg.
  • Are receiving extra oxygen.
  • Have mature retinas, the light-sensing layers at the back of the eyes.

Who can't join

  • Have major birth defects.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Between 22w 0/7d and 31w 6/7d gestation at birth * Diagnosed with echocardiographic pulmonary hypertension (1) \>20% flow of blood across the PDA from the pulmonary to arterial circulation, (2) end-systolic flattening of the interventricular septum (eccentricity index \>1.3), or (3) right ventricular pressure estimates ≥ 35 mm Hg * Receiving supplemental oxygen * Have mature retinas Exclusion Criteria: * Major congenital anomalies

Study sites (2)

AL

CT