Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants (PHOX)

The University of Alabama at Birmingham

Status: Begins enrollment in 1 month

Conditions: Bronchopulmonary Dysplasia; Pulmonary Hypertension

Treatments: Device: lower oxygen saturation target using Nellcor pulse oximetry sensors; Device: higher oxygen saturation target using Nellcor pulse oximetry sensors

Study type: Interventional

Funder types: Other

Identifiers

NCT06373289

1K23HD113837-01A1 (Other Identifier)

000539476

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 estimated patients

Sex: All

Ages: 1 to 5 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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39 participants in 2 patient groups

Oxygen saturation target 92-95%

Active Comparator group

Description:

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.

Treatment:

Device: lower oxygen saturation target using Nellcor pulse oximetry sensors

Oxygen saturation target 95-98%

Active Comparator group

Description:

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.

Treatment:

Device: higher oxygen saturation target using Nellcor pulse oximetry sensors