Impact of a non-invasive positive pressure ventilation protocol in comparation with non-protocolised strategy of ventilation in children hospitalised with acute respiratory failure

Impact of a non-invasive positive pressure ventilation protocol in children hospitalized with acute respiratory failure: A randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77954355

Enrollment

Registered

2017-01-06

Start date

2013-05-01

Completion date

Unknown

Last updated

2020-02-03

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

Conditions

Acute lower respiratory infection Respiratory Acute lower respiratory infection

Interventions

Patients included in the study are randomized to management of ventilatory support according to usual medical criteria (control group or CG) or to protocolized management of ventilatory support (proto

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hospitalized in Hospital Josefin Martinez 2. Aged between 3 months and 2 years 3. Diagnosis of acute lower respiratory infection 4. Need of NIPPV, according to Modified Wood Scale (MWS) with score = 4 points

Exclusion criteria

Exclusion criteria: 1. Prior use of NIV 2. History of respiratory comorbidities

Design outcomes

Primary

Measure	Time frame
1. Time of connection to Non Invasive Positive Pressure ventilation (NIPPV) measured in hours by a record table (designed for the purpose of this study) at baseline, and follow up until withdrawal occurs 2. Duration of hospitalization measured in hours by a record table (designed for the purpose of this study) at baseline, and follow up until discharge occurs 3. Use of additional oxygen after withdrawal of NIPPV measured in hours by a record table (designed for the purpose of this study) at baseline, and follow up until discontinuation	—

Measure

Time frame

1. Time of connection to Non Invasive Positive Pressure ventilation (NIPPV) measured in hours by a record table (designed for the purpose of this study) at baseline, and follow up until withdrawal occurs 2. Duration of hospitalization measured in hours by a record table (designed for the purpose of this study) at baseline, and follow up until discharge occurs 3. Use of additional oxygen after withdrawal of NIPPV measured in hours by a record table (designed for the purpose of this study) at baseline, and follow up until discontinuation

—

Secondary

Measure	Time frame
1. Severity of respiratory symptoms is measured using the Modified Wood Scale Score (MWS) at baseline and 1 hour after NIPPV start 2. Severity of respiratory symptoms in the protocol group is measured using the Modified Wood Scale Score (MWS) at baseline and 1, 24 hours after NIPPV start and at 4 hours after change of mode to CPAP prior to disconnection 3. Oxygenation in the protocol group after connection to NIPPV measured using the SAFI index at 1 and 24 hours after NIPPV start 4. Proportion of intubation (Need of Invasive ventilator support) measured frequency and % at the end of follow up	—

Measure

Time frame

1. Severity of respiratory symptoms is measured using the Modified Wood Scale Score (MWS) at baseline and 1 hour after NIPPV start 2. Severity of respiratory symptoms in the protocol group is measured using the Modified Wood Scale Score (MWS) at baseline and 1, 24 hours after NIPPV start and at 4 hours after change of mode to CPAP prior to disconnection 3. Oxygenation in the protocol group after connection to NIPPV measured using the SAFI index at 1 and 24 hours after NIPPV start 4. Proportion of intubation (Need of Invasive ventilator support) measured frequency and % at the end of follow up

—

Countries

Chile

Outcome results

None listed

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