Recruiting

Oxygen Targets

Sponsor:

University of Alabama at Birmingham

Code:

NCT06373289

Conditions

Bronchopulmonary Dysplasia

Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

higher oxygen saturation target using Nellcor pulse oximetry sensors

lower oxygen saturation target using Nellcor pulse oximetry sensors

Study Details

Brief 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.

Conditions

Bronchopulmonary Dysplasia

Pulmonary Hypertension

Study ID

NCT06373289

Start date

Sep 15, 2026

Status verified date

Aug, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Jul 6, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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 Design

Enrollment

39 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

higher oxygen saturation target using Nellcor pulse oximetry sensors

The intervention will be a cross over exposure to the higher oxygen saturation target.

lower oxygen saturation target using Nellcor pulse oximetry sensors

The intervention will be a cross over exposure to the lower oxygen saturation target.

Primary outcome measure

  • Intermittent hypoxemia event duration [ Time Frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first ]

Central Contacts and Locations

Central contacts

Samuel Gentle, MD

205-541-2247samjgentle@gmail.com

Colm Travers

samuel.gentle@yale.edu

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Colm Travers

205-934-4011cptravers@uabmc.edu

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Samuel Gentle

205-541-2247samuel.gentle@yale.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-26.