Status:
TERMINATED
Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
Lead Sponsor:
Alan Fujii
Collaborating Sponsors:
Dey LP
Conditions:
Prematurity
Respiratory Distress Syndrome
Eligibility:
All Genders
Up to 8 years
Phase:
PHASE4
Brief Summary
Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more...
Detailed Description
Specific Aims: * To determine whether there is a sustained difference in the level of respiratory support during the first 3 days of life in extremely premature infants treated with Curosurf versus S...
Eligibility Criteria
Inclusion
- \<29 6/7 and \>24 0/7 weeks gestational age
- Inborn at the participating institution enrolling the patient
- FIO2 \>25% and Intubated with mean airway pressure \> 5 cm H20
- \<8 hours age at randomization
- Signed informed consent from parent(s)
Exclusion
- \<500 g birth weight
- \<24 0/7 weeks gestational age (best estimate)
- Prolonged Premature Rupture of membranes \>3 weeks (21 days)
- Apgar score \< 3 at 5 minutes
- Impending death anticipated within the first 3 days of life, moribund
- Severe congenital anomalies
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00767039
Start Date
January 1 2005
End Date
January 1 2009
Last Update
October 3 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Boston Medical Center
Boston, Massachusetts, United States, 02118