Respiratory Transition Without Continuous Positive Airway Pressure

Hackensack Meridian Health

Status and phase: Enrolling; Early Phase 1

Conditions: Mild Respiratory Distress

Treatments: Other: Transition without Continuous Positive Airway Pressure (CPAP); Other: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT07390812

Pro2022-0654

Details and patient eligibility

About

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).

Enrollment: 35 estimated patients

Sex: All

Ages: 37 to 41 weeks old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

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

Treatment:

Other: CPAP

Watchful waiting

Experimental group

Description:

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

Treatment:

Other: Transition without Continuous Positive Airway Pressure (CPAP)