Status:
COMPLETED
Noninvasive Continuous Positive Airway Pressure (NCPAP) in Children
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Acute Respiratory Failure
Eligibility:
All Genders
1-24 years
Phase:
PHASE3
Brief Summary
In critically ill pediatric patients with Acute Respiratory Failure (ARF), Noninvasive Continuous Positive Airway Pressure (NCPAP) is applied to avoid intubation and all related complications such as ...
Detailed Description
Prospective, randomized, multicenter clinical study on parallel groups involving all consecutive infants ageing \>1 month \<2 yrs, admitted to PICU at Fondazione IRCCS Ca'Granda Ospedale Maggiore Poli...
Eligibility Criteria
Inclusion
- PaO2/FiO2 ratio \<300
- Respiratory rate \>50 breaths/min
- Chest x-ray compatible with pulmonary infection
- No clinical improvement after breathing oxygen at 8 l/min or more for at least 15 min
Exclusion
- Presence of an endotracheal tube or a tracheostomy before PICU admission
- Facial deformities
- Upper airway obstruction
- Cyanotic congenital heart disease
- Facial trauma
- Recurrent apnea
- Neuromuscular weakness
- Pulmonary hypoplasia
- Pulmonary vascular anomalies
- Imminent respiratory or cardiac arrest
- COPD and/or chronic CO2 retention
- Status asthmaticus
- Pneumothorax
- Hemodynamic instability
- Alteration in consciousness with a Glasgow coma score (GCS) \<10
- Aspiration or excessive bronchial secretions
- Enrollment in other research protocol
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01242150
Start Date
December 1 2008
End Date
December 1 2013
Last Update
January 22 2014
Active Locations (4)
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1
Department of Anesthesia and Intensive Care, Vittore Buzzi Children's Hospital
Milan, Italy
2
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
3
Department of Anesthesia and Intensive Care, Policlinico Gemelli
Rome, Italy
4
Department of the Environment, Healthy and Safety, University of Insubria
Varese, Italy