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Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

NCT06373289 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-03-27

No results posted yet for this study

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

Interventions

DEVICE

higher oxygen saturation target using Nellcor pulse oximetry sensors

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

DEVICE

lower oxygen saturation target using Nellcor pulse oximetry sensors

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

Sponsors & Collaborators

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

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Samuel Gentle · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
1 Month
Max Age
5 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-07-01
Completion
2030-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06373289 on ClinicalTrials.gov