Respiratory Transition Without Continuous Positive Airway Pressure

Conditions

• Mild Respiratory Distress

Eligibility Criteria

Sex

ALL

Age

37 Weeks - 41 Weeks

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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 Dates

Start date

Jan 11, 2023

Status verified

Feb 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

22 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard of care
  Continuous positive airway pressure (CPAP) is administered for mild respiratory distress
• 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

Primary Outcome Measure

Need for CPAP use at 25 minutes of life [ Time Frame: At 25 minutes post birth (after 20 minutes of observation) ]

Locations (1)

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