NCT06373289

Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Month – 5 Months
• Healthy volunteers: Accepted

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.

Detailed description

Infants born between 22.0 to 31.6 weeks' gestational age with bronchopulmonary dysplasia associated pulmonary hypertension, are receiving supplemental oxygen, and have mature retinas will be randomized to SpO2 targets of either (1) 92-95% (control) or (2) 95-98% (intervention). Using a cross over design with a 1:1 parallel allocation of infants randomized using a stratified permuted block design. Following 1week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period. Bedside providers will follow pre-specified algorithms to maintain oxygen targets during the randomization period. Reports of oxygen saturation performance will also be provided to bedside providers through oxygen saturation histograms.

Conditions

• Bronchopulmonary Dysplasia
• Pulmonary Hypertension

Interventions

Type	Name	Description
DEVICE	higher oxygen saturation target using Nellcor pulse oximetry sensors	The intervention will be a cross over exposure to the higher oxygen saturation target.
DEVICE	lower oxygen saturation target using Nellcor pulse oximetry sensors	The intervention will be a cross over exposure to the lower oxygen saturation target.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-07-01
• Completion: 2030-07-01
• First posted: 2024-04-18
• Last updated: 2026-03-27

Locations

2 sites across 1 country: United States