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NCT Number: NCT07390812

Respiratory Transition Without Continuous Positive Airway Pressure

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mild Respiratory Distress

Age range

37 week–41 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hackensack Univeristy Medical Center

Hackensack, New Jersey, 07601, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transition without Continuous Positive Airway Pressure (CPAP)

Other

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

CPAP

Other

CPAP administration as per standard of care

Primary outcomes

  1. Need for CPAP use at 25 minutes of life

    Time frame: At 25 minutes post birth (after 20 minutes of observation)

    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.

Secondary outcomes

  1. Prevalence of pneumothorax in neonates

    Time frame: Within 6 hours of life

    Number of babies with pneumothorax in neonates as assessed by a chest ultrasound.

  2. NICU (Neonatal Intensive Care Unit) admission during hospital stay

    Time frame: Hospital day (from birth to discharge)

    Number of babies admitted to the NICU for respiratory distress during the initial hospital stay (on average, 1-4 days).

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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