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

Status: Recruiting

Location: See all (2) locations...

Intervention Type: Device

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 1 month

Maximum Age: 5 months

Healthy Volunteers: t

View:

• 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

Locations

United States

Alabama

The University of Alabama at Birmingham

RECRUITING

Birmingham

Connecticut

Yale New Haven Hospital

RECRUITING

New Haven

Contact Information

Primary

Samuel Gentle, MD

samjgentle@gmail.com

205-541-2247

Backup

Colm Travers

samuel.gentle@yale.edu

Time Frame

Start Date: 2026-04

Estimated Completion Date: 2030-07-01

Participants

Target number of participants: 39

Treatments

Active_comparator: Oxygen saturation target 92-95%

At UAB and Yale oxygen saturation targeting is achieved using systematic oxygen saturation histogram monitoring every 3-4 hours by nurse, respiratory therapists, and physicians. Upon randomization to this arm, infants oxygen saturation alarm limits will be adjusted to 92-95% after which an FiO2 modification algorithm will be employed to maintain targets. Daily compliance reports will be generated to ensure oxygen saturation achievement corresponds with oxygen saturation targets. Infants will be exposed to a 1 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets.

Active_comparator: Oxygen saturation target 95-98%

At UAB and Yale oxygen saturation targeting is achieved using systematic oxygen saturation histogram monitoring every 3-4 hours by nurse, respiratory therapists, and physicians. Upon randomization to this arm, infants oxygen saturation alarm limits will be adjusted to 95-98% after which an FiO2 modification algorithm will be employed to maintain targets. Daily compliance reports will be generated to ensure oxygen saturation achievement corresponds with oxygen saturation targets. Infants will be exposed for a 1 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets.

Related Therapeutic Areas

High Blood Pressure in Infants

Hypertension

Bronchopulmonary Dysplasia

Pulmonary Hypertension