Status:
COMPLETED
Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)
Lead Sponsor:
Clarassance, Inc.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Respiratory Distress Syndrome in Premature Infant
Bronchopulmonary Dysplasia
Eligibility:
All Genders
24-29 years
Phase:
PHASE1
PHASE2
Brief Summary
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and in...
Eligibility Criteria
Inclusion
- Newborn infants were considered for the study if the following criteria were met:
- Age \< 24 hours;
- Birthweight between 700 and 1,300 grams;
- Gestational age greater than or equal to 24 weeks;
- Diagnosis of neonatal RDS based on clinical and radiographic criteria;
- Requiring intubation and mechanical ventilation for treatment of RDS;
- Received at least one dose of surfactant 100 mg/kg (Survanta; Ross Laboratories);
- Written informed consent from the infant's parent or legal guardian prior to enrollment of the patient and agrees to all study-related procedures and evaluations, including those required after hospital discharge.
Exclusion
- • Major congenital abnormalities (chromosomal, genetic, cardiac, pulmonary, or renal);
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01473264
Start Date
January 1 2000
End Date
December 1 2003
Last Update
November 17 2011
Active Locations (4)
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1
Christiana HealthCare Systems
Wilmington, Delaware, United States, 19899
2
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
3
Mercy Medical Center
Baltimore, Maryland, United States, 21202
4
Winthrop-University Hospital, SUNY Stony Brook School of Medicine
Mineola, New York, United States, 11501