Status:
TERMINATED
Extubation Readiness Study in Very Low Birthweight Infants
Lead Sponsor:
University of Pennsylvania
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
48-14 years
Phase:
NA
Brief Summary
The objective of this study is to determine whether use of the spontaneous breathing trial allows for earlier successful extubation of very low birth weight (VLBW) infants who are intubated for \>48 h...
Eligibility Criteria
Inclusion
- Birthweight \>500g and\<1500g.
- Postmenstrual age \<34 weeks
- Mechanically ventilated \>48 hours
- Never successfully extubated
Exclusion
- Congenital heart disease (other than patent ductus arteriosus (PDA), patent foramen ovale (PFO), and restrictive ventricular septal defect (VSD)
- Known or suspected airway anomalies
- Severe congenital malformations
- Need to remain intubated for other reasons (i.e. having surgery)
- Has met SBT criteria on previous calendar day (after 48 hrs of ventilation, PIP≤18, PEEP≤6, FiO2≤40%, Rate≤30, PS≤8)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01471431
Start Date
August 1 2011
End Date
April 1 2016
Last Update
June 7 2016
Active Locations (2)
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1
The Hospital of the University of Pennsylvania
Phialdelphia, Pennsylvania, United States, 19104
2
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107