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Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

University of Alabama at Birmingham · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT06373289

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 1 mo–5 mo · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
39
US sites recruiting
2
Study start
September 22, 2026
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: higher oxygen saturation target using Nellcor pulse oximetry sensors; lower oxygen saturation target using Nellcor pulse oximetry sensors

Conditions: Bronchopulmonary Dysplasia; Pulmonary Hypertension

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • The University of Alabama at Birmingham

    Birmingham, AL 35294

    Site contact: Colm Travers · 205-934-4011 · cptravers@uabmc.edu

  • Yale New Haven Hospital

    New Haven, CT 06510

    Site contact: Samuel Gentle · 205-541-2247 · samuel.gentle@yale.edu

Study contacts (from the official record)

  • Samuel Gentle, MD · 205-541-2247 · samjgentle@gmail.com
  • Colm Travers · samuel.gentle@yale.edu
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