Trial of different methods of stabilizing mature newborns with breathing difficulty at birth

Effect of Continuous Positive Airway Pressure versus Free Flow Oxygen on Treatment Failure during Delivery Room Stabilization in Neonates more than or equal to 35 weeks : A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102015

Enrollment

250

Registered

2026-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: P22- Respiratory distress of newborn Health Condition 2: P221- Transient tachypnea of newborn

Interventions

Intervention1: Continuous positive airway pressure: T piece resuscitator (through Drager resuscitaire infant warmer connected to central gas supply of hospital) will be used for providing DR CPAP via

Laerdel, Stavanger, Norway) will be used to deliver CPAP. Control Intervention1: Free flow oxygen: Free flow oxygen will be provided by oxygen by hood at 10 L/min and FiO2 30% which will be titrated a

Eligibility

Inclusion criteria

Inclusion criteria: Neonates born at or more than 35 weeks of gestation with spontaneous breathing and HR more than 100 per min with RD at birth defined as at least one of the following signs of increased work of breathing such as Tachypnea (respiratory rate more than 60/min), Chest retractions, Not able to maintain minute-specific target saturation or more than 90% after 10 minutes of life, Nasal flaring, and Grunting.

Exclusion criteria

Exclusion criteria: Neonates with major congenital malformations, Neonates requiring PPV or intubation at birth

Design outcomes

Primary

Measure	Time frame
Incidence of treatment failure, defined as any: Need for NICU admission (persistence of RD or not able to maintain SpO2 more than 90% on room air at one hour of life), Escalation of respiratory support (on worsening of RD or FiO2 requirement more than 0.5 despite 30 minutes of intervention), or Need for PPV or intubation in the delivery room after randomization (as decided by treating team)Timepoint: One hour of life	—

Measure

Time frame

Incidence of treatment failure, defined as any: Need for NICU admission (persistence of RD or not able to maintain SpO2 more than 90% on room air at one hour of life), Escalation of respiratory support (on worsening of RD or FiO2 requirement more than 0.5 despite 30 minutes of intervention), or Need for PPV or intubation in the delivery room after randomization (as decided by treating team)Timepoint: One hour of life

—

Secondary

Measure	Time frame
LUS scoreTimepoint: Within 2 hours of life;Incidence of pneumothorax Timepoint: 24 hours of life;Need and duration of invasive and non-invasive respiratory support in NICUTimepoint: At hospital discharge;Length of hospital stay Timepoint: At hospital discharge	—

Countries

India

Contacts

Public ContactDr Mayank Priyadarshi

AIIMS Rishikesh

pragyam614@gmail.com9919427357

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026