Clinical trial NCT06373289: Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
Official title: Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Pulmonary Hypertension
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 39
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single center, randomized cross-over pilot study with a 1:1 parallel allocation of infants to SpO2 targets of 92-95% (control) and 95-98% (intervention) using a stratified permuted block design. Following 1 week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Intermittent hypoxemia event duration
timeFrame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Secondary outcomes:
measure: Echocardiographic shunting
timeFrame: through study completion, 3 weeks from date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
measure: Echocardiographic interventricular septal flattening
timeFrame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
measure: Echocardiographic tricuspid regurgitation
timeFrame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
measure: Intermittent hypoxemia frequency
timeFrame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
measure: Cumulative hypoxemia
timeFrame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
measure: Brain natriuretic peptide
timeFrame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Samuel Gentle
role: PRINCIPAL_INVESTIGATOR
References: