Respiratory Transition Without Continuous Positive Airway Pressure

Running, not enrolling · Early Phase 1

Conditions studied: Mild Respiratory Distress

In brief

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).

Key facts

Study ID

NCT07390812

Run by

Hackensack Meridian Health

People needed

22

Starts

2023-01-11

Expected to finish

2026-12-01

Last updated by the study team

2026-02-27

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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