Respiratory Transition Without Continuous Positive Airway Pressure

NCT07390812 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: Pro2022-0654
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mild respiratory distress; term neonates; continuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

• Need for CPAP use at 25 minutes of life

  Babies with mild respiratory distress will be observed for 20 minutes (randomized at 5 minutes of life) using a pulse oximeter (per institutional post-resuscitation care guidelines) and under the study team's direct observation. The active cohort will not receive CPAP unless respiratory distress worsens.

  At 25 minutes post birth (after 20 minutes of observation)

Secondary Outcomes (2)

• Prevalence of pneumothorax in neonates

  Within 6 hours of life

• NICU (Neonatal Intensive Care Unit) admission during hospital stay

  Hospital day (from birth to discharge)

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Continuous positive airway pressure (CPAP) is administered for mild respiratory distress

Other: CPAP

Watchful waiting

EXPERIMENTAL

Neonates with mild respiratory distress are observed for 20 minutes, and CPAP is administered at 25 minutes of life if respiratory distress continues or earlier if moderate to severe respiratory distress occurs

Other: Transition without Continuous Positive Airway Pressure (CPAP)

Interventions

CPAP OTHER

CPAP administration as per standard of care

Standard of care

Transition without Continuous Positive Airway Pressure (CPAP) OTHER

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

Watchful waiting

Eligibility Criteria

• Age: 37 Weeks - 41 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Full term infants (37 weeks + 0days to 41 weeks +6days gestational age)
• Born via scheduled c-sections without labor
• Who develop mild respiratory distress, defined as nasal flaring or, intermittent grunting, and/or mild retractions and/or +/- mild tachypnea ( respiratory rate 61-90).

You may not qualify if:

• Moderate to severe respiratory distress (continuous grunting, or moderate retractions or respiratory rate greater than 90 breaths per minute),
• need for positive pressure ventilation (PPV) or advanced resuscitation in the first 5 minutes of life,
• meconium stained amniotic fluid,
• major congenital anomalies or chromosomal abnormalities.

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack Univeristy Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Nicole Spillane, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 5, 2026
• Study Start: January 11, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)