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Search / Trial NCT06373289

Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Apr 17, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how different levels of oxygen can help improve the health of very premature infants who have a condition called bronchopulmonary dysplasia. This condition affects their lungs and can lead to a serious problem known as pulmonary hypertension, which can be life-threatening. The goal of the study is to find out if adjusting the amount of oxygen these babies receive can lead to better outcomes, helping to reduce the risks associated with these conditions.

To participate in this trial, infants need to be born extremely premature, between 22 weeks and 31 weeks of gestation, and have a diagnosis of pulmonary hypertension based on specific heart tests. They also need to be receiving extra oxygen and have certain eye conditions related to their prematurity. The trial is not yet recruiting participants, but once it begins, families of eligible infants can expect to have their baby's oxygen levels carefully monitored and adjusted as part of the study. This research is important because it may help doctors understand the best ways to care for these vulnerable infants and improve their chances for a healthier future.

Gender

ALL

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

About University Of Alabama At Birmingham

The University of Alabama at Birmingham (UAB) is a prominent academic institution and research hub dedicated to advancing healthcare through innovative clinical trials. Renowned for its commitment to medical discovery and education, UAB conducts cutting-edge research across a wide array of disciplines, including oncology, cardiology, neurology, and public health. With a robust infrastructure for clinical research, UAB fosters collaboration among interdisciplinary teams, leveraging state-of-the-art facilities and resources to enhance the translation of scientific findings into effective treatments and interventions. As a leader in clinical research, UAB aims to improve patient outcomes and contribute to the broader medical community through rigorous trial design and implementation.

Locations

Birmingham, Alabama, United States

New Haven, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Samuel Gentle

Principal Investigator

University of Alabama at Birmingham

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported