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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Page 1 of 1 (2 locations)

1

Health sciences Center

Winnipeg, Manitoba, Canada

2

St Boniface Hospital

Winnipeg, Manitoba, Canada