Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501982
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2007-07-16
Brief Title:
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room the Curpap Study
Sponsor:
Chiesi Farmaceutici SpA
Organization:
Chiesi Farmaceutici SpA
Study Overview
Official Title:
An International Open Randomized Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Risk of Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Curpap
Brief Summary:
The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications such as BPD in premature babies at high risk of RDS
1 Early stabilization on nCPAP
2 Intubation prophylactic surfactant Curosurf administration shortly after delivery and rapid extubation to nCPAP
The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant nCPAP show less need for MV when compared to infants who receive nCPAP alone
1 Early stabilization on nCPAP
2 Intubation prophylactic surfactant Curosurf administration shortly after delivery and rapid extubation to nCPAP
The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant nCPAP show less need for MV when compared to infants who receive nCPAP alone
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None