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Respiratory Transition Without Continuous Positive Airway Pressure

NCT07390812 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-02-27

No results posted yet for this study

Summary

The primary aim of this research project is to determine if term neonates (37:0 to 41:6 weeks' gestational age) with mild respiratory distress can safely transition without continuous positive airway pressure (CPAP). The secondary aim is to determine the incidence of pneumothorax (PTX) for all term neonates assessed to have mild respiratory distress in the delivery room (DR).

Conditions

  • Mild Respiratory Distress

Interventions

OTHER

Transition without Continuous Positive Airway Pressure (CPAP)

Allowing transition without CPAP administration was assessed at 25 minutes of life

OTHER

CPAP

CPAP administration as per standard of care

Sponsors & Collaborators

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Nicole Spillane, MD · Hackensack Meridian Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
37 Weeks
Max Age
41 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2026-12-31
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 NCT07390812 on ClinicalTrials.gov