Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS

NACompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Respiratory Distress Syndrome
Interventions
DEVICE

ECALMIST

Labelled catheter at level of the lips (6 cm plus weight) will inserted through the vocal cords under direct vision using a standard laryngoscope without premedication while maintaining CPAP. 5 ml/kg surfactant syringe will be connected to the catheter hub and 0.25-0.5 ml was administered; then the syringe will be disconnected from the catheter to observe the surfactant moving up and down or coming back as indication of accurate intubation of the trachea. The surfactant the slowly administer by boluses of 0.25-0.5 ml over 20-30 seconds with 10 seconds apart. At the end of the procedure, the operator flushed the catheter with 0.5 ml of air before removing the catheter while maintaining CPAP

DEVICE

ECALMIST

Vascular catheter of 1.6 French size of 133 mm length 16 gauge used to deliver the BLES; a large volume surfactant while maintain CPAP

Trial Locations (3)

R3C0L8

Children hospital of health Sciences Center, Winnipeg

Women's Hospital Health Science Center, Winnipeg

Unknown

St. Boniface Hospital, Winnipeg

All Listed Sponsors
lead

University of Manitoba

OTHER

NCT01553292 - Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS | Biotech Hunter | Biotech Hunter