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NCT Number: NCT06373289

Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hypertension Hypertension, Pulmonary Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases Ventilator-Induced Lung Injury

Age range

1 month–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

higher oxygen saturation target using Nellcor pulse oximetry sensors

Device

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

lower oxygen saturation target using Nellcor pulse oximetry sensors

Device

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

Primary outcomes

  1. Intermittent hypoxemia event duration

    Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first

    The average duration of time (in seconds) an infant's oxygen saturation decrease below 80%.

Secondary outcomes

  1. Echocardiographic shunting

    Time frame: through study completion, 3 weeks from date of randomization until 3 weeks have elapsed or date of discharge, whichever came first

    >20% flow of blood across the PDA from the pulmonary to arterial circulation

  2. Echocardiographic interventricular septal flattening

    Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first

    End-systolic flattening of the interventricular septum (eccentricity index >1.3)

  3. Echocardiographic tricuspid regurgitation

    Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first

    Right ventricular pressure estimates

  4. Intermittent hypoxemia frequency

    Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first

    Number of daily events during which an infant's oxygen saturation decreases below 80%

  5. Cumulative hypoxemia

    Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first

    Daily duration during which an infant's oxygen saturation is <80%

  6. Brain natriuretic peptide

    Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first

    A polypeptide released from the cardiac ventricles indicative of right heart strain

Study contacts

Contact information is provided by the study sponsor or research team.

Colm Travers

CONTACT

[email protected]

Samuel Gentle, MD

CONTACT

[email protected]

205-541-2247

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: PHOX

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 18, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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