Respiratory Transition Without Continuous Positive Airway Pressure

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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07390812

Enrollment

Registered

2026-02-05

Start date

2023-01-11

Completion date

2026-12-01

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Respiratory Distress

Keywords

mild respiratory distress, term neonates, continuous positive airway pressure

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).

Interventions

OTHERTransition without Continuous Positive Airway Pressure (CPAP)

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

OTHERCPAP

CPAP administration as per standard of care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

37 Weeks to 41 Weeks

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Need for CPAP use at 25 minutes of life	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

Measure	Time frame	Description
Prevalence of pneumothorax in neonates	Within 6 hours of life	Number of babies with pneumothorax in neonates as assessed by a chest ultrasound.
NICU (Neonatal Intensive Care Unit) admission during hospital stay	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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNicole Spillane, MD

Hackensack Meridian Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026