Use of Orotracheal Continuous Positive Airway Pressure (CPAP) in Newborns With Respiratory Failure
Use of Orotracheal CPAP ( Gregory System) for Treatment of Respiratory Failure in Newborns
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
Nasal CPAP is a excellent ventilation modality for newborns, but the incidence of pneumothorax is high (65.% - 9%) our hypothesis is when the baby open the mouth or crie the pressure in the airway is variable, the investigators evaluate a closed system with a intubated baby with a orotracheal system but with a elastic reservoir , the reservoir distend and the pressure in the airway is constant ,with this system the investigators protect the lungs for damage . The investigators want compare the use of nasal CPAP, mechanical ventilation and orotracheal CPAP with a compensation bag (gregory system) in newborns with respiratory failure .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 22, 2011
CompletedFirst Posted
Study publicly available on registry
June 23, 2011
CompletedJune 23, 2011
June 1, 2011
Same day
June 22, 2011
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mortality. pneumothorax , oxygen at 36 weeks of gestational age
we compare mortality. pneumothorax , oxygen at 36 weeks of gestational age in all the groups , mechanical ventilation , Nasal CPAP and orotracheal CPAP
at 36 weeks of gestational age
Secondary Outcomes (1)
infections rate, failure to treatment , other complications.
36 weeks of gestational age
Interventions
USE OF OROTRACHEAL CPAP FOR RESPIRATORY DISTRESS SYNDROME IN NEWBORNS .
Eligibility Criteria
You may qualify if:
- newborns with respiratory disease preterm less 32 week of gestational age.
You may not qualify if:
- newborns without respiratory disease or 33 week of gestational age or more.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 22, 2011
First Posted
June 23, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 23, 2011
Record last verified: 2011-06