Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187447
Status:
COMPLETED
Last Update Posted:
2008-06-04
First Post:
2005-09-10
Brief Title:
Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at 28 Weeks Gestation With a Persistent Patent Ductus Arteriosus
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at 28 Weeks Gestation With a Persistent Patent Ductus Arteriosus
Status:
COMPLETED
Status Verified Date:
2005-09
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:
None
Brief Summary:
The purpose of this study is to examine if a higher dose of indomethacin will increase the rate of ductus arteriosus closure in extremely premature infants without increasing the side effects The long term objective is to find the optimal dosing of indomethacin for permanent closure of the Ductus and prevent the morbidity related to PDA and the complications of surgical ligation
Detailed Description:
This study is a Phase II randomized masked controlled trial that compares the current standard dose of indomethacin to a higher dose for the closure of PDA in premature infants less than 28 weeks of gestation
Neonates 28 weeks gestation who are started on indomethacin treatment with an initial 3-dose course 02 01 and 01 mgkg of indomethacin within the first 96 hr after birth will be eligible for this trial if they continue to have Doppler evidence of ductus patency before the third dose of indomethacin This group of infants have greater than 65 chance of developing symptomatic PDA and surgical ligation even after our standard extended course of indomethacin Those infants who do not fit the exclusion criteria will be randomized to either a Standard Dose group or to a Higher Dose group after obtaining consent The infants randomized to the standard group will receive a 4th 5th and 6th dose of indomethacin 01 mgkg at 24 hr intervals starting at 24 hr after the 3rd dose The Higher Dose group infants delivered between 26-27 weeks gestation will receive a 4th 5th 6th 7th 8th and 9th dose of indomethacin 01mgkg at 12 hr intervals starting 12 hr after the 3rd dose The Higher Dose group infants between 24-25 weeks gestation will receive a 4th 5th 6th 7th 8th and 9th dose of indomethacin 025mgkg at 12 hour intervals starting 12 hr after the 3rd dose To keep the study blinded the standard group will receive 3 extra doses of saline to match the 3 additional doses given to the higher dose group
Neonates 28 weeks gestation who are started on indomethacin treatment with an initial 3-dose course 02 01 and 01 mgkg of indomethacin within the first 96 hr after birth will be eligible for this trial if they continue to have Doppler evidence of ductus patency before the third dose of indomethacin This group of infants have greater than 65 chance of developing symptomatic PDA and surgical ligation even after our standard extended course of indomethacin Those infants who do not fit the exclusion criteria will be randomized to either a Standard Dose group or to a Higher Dose group after obtaining consent The infants randomized to the standard group will receive a 4th 5th and 6th dose of indomethacin 01 mgkg at 24 hr intervals starting at 24 hr after the 3rd dose The Higher Dose group infants delivered between 26-27 weeks gestation will receive a 4th 5th 6th 7th 8th and 9th dose of indomethacin 01mgkg at 12 hr intervals starting 12 hr after the 3rd dose The Higher Dose group infants between 24-25 weeks gestation will receive a 4th 5th 6th 7th 8th and 9th dose of indomethacin 025mgkg at 12 hour intervals starting 12 hr after the 3rd dose To keep the study blinded the standard group will receive 3 extra doses of saline to match the 3 additional doses given to the higher dose group
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