Noninvasive Continuous Positive Airway Pressure (CPAP) by a new pediatric helmet in infants with acute respiratory failure: A comparison with standard full face mask CPAP system

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26963869

Enrollment

Registered

2007-07-30

Start date

2007-01-01

Completion date

Unknown

Last updated

2021-11-08

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

Conditions

Acute respiratory failure, hypoxemic Respiratory Acute respiratory failure, hypoxemic

Interventions

Each infant was randomized to treatment with either helmet or mask CPAP (duration: 90 min). Then the infant was treated with the other CPAP (i.e. those who had been treated with helmet CPAP in the ini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Acute respiratory distress including the following: 1. PaO2:FiO2 <300 mmHg 2. Bilateral lung infiltrates on chest x-ray 3. Age <2 years

Exclusion criteria

Exclusion criteria: 1. Underlying chronic lung disease, such as bronchopulmonary dysplasia and cystic fibrosis 2. Inability to clear major tracheal secretions 3. Requirement for emergency intubation including persistent apnea or cardiopulmonary resuscitation 4. Cardiac disease 5. Presence of more than two new organ failures 6. Tracheostomy 7. Coma 8. Tecent orogastric surgery

Design outcomes

Primary

Measure	Time frame
Tolerance	—

Secondary

Measure	Time frame
1. Gas exchange 2. Respiratory effort	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026