Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

NCT06373289 | Recruiting DMC

• 2 other identifiers: 0005394761K23HD113837-01A1
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchopulmonary Dysplasia; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Intermittent hypoxemia event duration

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

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

Secondary Outcomes (6)

• Echocardiographic shunting

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

• Echocardiographic interventricular septal flattening

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

• Echocardiographic tricuspid regurgitation

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

• Intermittent hypoxemia frequency

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

• Cumulative hypoxemia

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

Study Arms (2)

Oxygen saturation target 92-95%

ACTIVE COMPARATOR

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.

Device: lower oxygen saturation target using Nellcor pulse oximetry sensors

Oxygen saturation target 95-98%

ACTIVE COMPARATOR

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.

Device: higher oxygen saturation target using Nellcor pulse oximetry sensors

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.

Oxygen saturation target 95-98%

lower oxygen saturation target using Nellcor pulse oximetry sensors DEVICE

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

Oxygen saturation target 92-95%

Eligibility Criteria

• Age: 1 Month - 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Major congenital anomalies

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Alabama at Birmingham: lead

Study Sites (2)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

• Samuel Gentle

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Gentle, MD

CONTACT

205-541-2247; samjgentle@gmail.com

Colm Travers

CONTACT

samuel.gentle@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The PI will perform bedside echocardiography precluding masking to group allocation. All echocardiograms will be further reviewed by a cardiologist masked to group allocation with additional cardiologist review in instances of disagreement. Inter-rater reliability testing will also be performed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 18, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)