Status:
UNKNOWN
ECALMIST Versus InSurE in Preterm Infant < 32 Weeks,Multicenter, Multinational RCT
Lead Sponsor:
University of Manitoba
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
24-31 years
Phase:
NA
Brief Summary
Minimally invasive surfactant therapy via a small vascular catheter - ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) versus InSurE (Intubate, Surfactant Extubate) in preter...
Detailed Description
After meeting all the inclusion criteria, eligible infants will be randomized to receive surfactant either through the ECALMIST or the InSurE methods. The attending neonatologist or neonatal team will...
Eligibility Criteria
Inclusion
- All should apply:
- Newborn less than 32 weeks gestation at birth
- Postnatal age \< 24 hrs of life
- Clinical diagnosis of RDS
- Spontaneously breathing on NCPAP
- Clinical decision to give surfactant.
Exclusion
- Lack of parental consent.
- Need for mechanical ventilation
- Major congenital malformation
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01848262
Start Date
June 1 2013
End Date
June 1 2015
Last Update
February 11 2014
Active Locations (2)
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1
Health sciences Center
Winnipeg, Manitoba, Canada
2
St Boniface Hospital
Winnipeg, Manitoba, Canada