Respiratory Transition Without Continuous Positive Airway Pressure

Respiratory Transition Without Continuous Positive Airway Pressure in Term Infants With Mild Respiratory Distress: A Pilot Study

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Mild Respiratory Distress
• Intervention / Treatment: Other: CPAP; Other: Transition without Continuous Positive Airway Pressure (CPAP)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Univeristy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Continuous positive airway pressure (CPAP) is administered for mild respiratory distress	Other: CPAP; CPAP administration as per standard of care
Experimental: Watchful waiting; 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); Allowing transition without CPAP administration was assessed at 25 minutes of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of pneumothorax in neonates	Number of babies with pneumothorax in neonates as assessed by a chest ultrasound.	Within 6 hours of life
NICU (Neonatal Intensive Care Unit) admission during hospital stay	Number of babies admitted to the NICU for respiratory distress during the initial hospital stay (on average, 1-4 days).	Hospital day (from birth to discharge)

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Investigators: Principal Investigator: Nicole Spillane, MD, Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: continuous positive airway pressure; term neonates; mild respiratory distress
• Additional Relevant MeSH Terms: Therapeutics; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Continuous Positive Airway Pressure
• Other Study ID Numbers: Pro2022-0654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No