Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome
|ClinicalTrials.gov Identifier: NCT01537354|
Recruitment Status : Withdrawn (Sponsor discontinued clinical trial before enrollment of subjects.)
First Posted : February 23, 2012
Last Update Posted : January 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome||Drug: Curosurf® Drug: Survanta®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Comparison of Immediate Changes in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||December 2013|
Active Comparator: Survanta®
Survanta® (Beractant, Abbot Laboratories, Columbus, OH) Surfactant will be administered by respiratory therapist not involved in patient's care.
Initial dose is 4 mL/kg (100 mg/kg phospholipids) administered via endotracheal tube. Subsequent doses if needed are 4 mL/kg (100 mg/kg phospholipids).
Active Comparator: Curosurf®
Curosurf® (Cornerstone Therapeutics, Inc., Cary, NC Surfactant will be administered by respiratory therapist not involved in patient's care.
Initial dose is 2.5ml/kg (200 mg/kg phospholipid) administered via endotracheal tube. Subsequent doses if needed are 1.25 mL/kg (100 mg/kg phospholipids).
- Change in dynamic compliance [ Time Frame: 15 minutes, 30 minutes, 45 minutes and then hourly intervals after administration of surfactant. Subjects' compliance will be monitored hourly after the first 60 minutes while they are being ventilated in the Neonatal Intensive Care Unit. ]Patient's dynamic compliance will be measured immediately after initial dosage, q15 minutes for 60 minutes and hourly for 48 hrs as long as intubated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537354
|United States, Michigan|
|University of Michigan C & W Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109-0245|
|Principal Investigator:||Steven Donn, M.D.||University of Michigan C & W Mott Children's Hospital|