Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

Conditions

• Bronchopulmonary Dysplasia
• Pulmonary Hypertension

Eligibility Criteria

Sex

ALL

Age

1 Month - 5 Months

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

Mar 2026

Primary completion

Jul 1, 2029

Completion

Jul 1, 2030

Study Design

Enrollment

39 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

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.

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

• Samuel Gentle, MD
  205-541-2247
  [email protected]
• Colm Travers
  [email protected]

Locations (2)

Find similar trials in Birmingham, AL

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