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Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension

NCT04938167 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-08

No results posted yet for this study

Summary

The purpose of this research is to evaluate two oxygen saturation goals for newborns with pulmonary hypertension. Participation in this research will involve random assignment to one of two oxygen saturation goals, review of the medical record and targeted echocardiograms.

Conditions

  • Persistent Pulmonary Hypertension of the Newborn
  • Hypoxemic Respiratory Failure

Interventions

OTHER

95% - 99% SpO2 target

If the infant is randomized to the intervention arm, the oxygen saturation goal will be changed from the standard goal of 91% - 95% to the experimental goal of 95%-99%. The treating medical team will then adjust the oxygen and respiratory support to maintain these goals (SpO2 alarm levels will be set at 93% and 100%).

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2024-12-31
Completion
2026-12-31

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 NCT04938167 on ClinicalTrials.gov