Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234247
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2005-10-04
Brief Title:
Prolonged Outcomes After Nitric Oxide PrONOx
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Study of the Long-term Outcomes of Nitric Oxide for Ventilated Premature Babies
Status:
COMPLETED
Status Verified Date:
2016-05
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 look at the long term consequences of prematurity in infants treated with inhaled nitric oxide iNO while in the neonatal intensive care unit
Detailed Description:
Prematurity-associated respiratory failure is a growing public health problem Although mortality has dropped with advances in perinatal care this condition consumes considerable healthcare resources and is increasingly associated with worrisome long-term morbidity developmental delay and family burden Inhaled nitric oxide iNO a selective pulmonary vasodilator that improves short-term outcomes in term neonates with respiratory failure may benefit premature infants Consequently a NHLBI-funded randomized controlled trial iNO RCT- NHLBI U01 HL064857 is assessing the effect of iNO on the combined end-point of mortality or oxygen dependency at 36 weeks post conceptional age in 800 infants with prematurity-associated respiratory failure
However prematurity-associated respiratory failure has a different etiology from respiratory failure in term infants and the wide array of long-term consequences that may be affected by iNO are not captured under the existing study design
We therefore are extending and enhance the follow-up of the NHLBI iNO RCT Specifically we are assessing the effects of INO use on 1 - long-term clinical and childhood developmental outcomes 2 - family burden and 3 - healthcare costs of prematurity-associated respiratory failure Under aim 4 we will use data from aims 1-3 to assess the cost-effectiveness of iNO in ventilated premature infants
We are achieving these aims by augmenting the NHLBI iNO RCT data collection with i survival follow-up for an average of 4 12 years ii comprehensive standardized follow-up clinic visits at 1 2 3 and 4 12 years to assess clinical outcomes childhood development and family burden iii structured telephone interviews with parents every 3 months in year 1 and every 6 months thereafter for an average of 4½ years to assess chronic morbidity and post-discharge healthcare use iv collection of detailed hospital bills for the primary hospitalization and v a comprehensive analysis plan
This study will allow us to determine the long-term consequences of iNO therapy in this condition aiding clinicians families and policymakers and immediately affecting care of critically ill infants By combining with the NHLBI iNO RCT we take advantage of an important opportunity to gather prospective long-term outcome data in a randomized fashion Our proposal will significantly increase the return on investment in the RCT through a greater understanding of the impact of iNO therapy from a societal perspective Neonatal intensive care has changed dramatically in the last ten years This study will also provide contemporary information on the long-term outcomes of prematurity-associated respiratory failure following modern management Finally our data will allow assessment of the robustness of early proxies for subsequent outcomes key for future study design in this area
However prematurity-associated respiratory failure has a different etiology from respiratory failure in term infants and the wide array of long-term consequences that may be affected by iNO are not captured under the existing study design
We therefore are extending and enhance the follow-up of the NHLBI iNO RCT Specifically we are assessing the effects of INO use on 1 - long-term clinical and childhood developmental outcomes 2 - family burden and 3 - healthcare costs of prematurity-associated respiratory failure Under aim 4 we will use data from aims 1-3 to assess the cost-effectiveness of iNO in ventilated premature infants
We are achieving these aims by augmenting the NHLBI iNO RCT data collection with i survival follow-up for an average of 4 12 years ii comprehensive standardized follow-up clinic visits at 1 2 3 and 4 12 years to assess clinical outcomes childhood development and family burden iii structured telephone interviews with parents every 3 months in year 1 and every 6 months thereafter for an average of 4½ years to assess chronic morbidity and post-discharge healthcare use iv collection of detailed hospital bills for the primary hospitalization and v a comprehensive analysis plan
This study will allow us to determine the long-term consequences of iNO therapy in this condition aiding clinicians families and policymakers and immediately affecting care of critically ill infants By combining with the NHLBI iNO RCT we take advantage of an important opportunity to gather prospective long-term outcome data in a randomized fashion Our proposal will significantly increase the return on investment in the RCT through a greater understanding of the impact of iNO therapy from a societal perspective Neonatal intensive care has changed dramatically in the last ten years This study will also provide contemporary information on the long-term outcomes of prematurity-associated respiratory failure following modern management Finally our data will allow assessment of the robustness of early proxies for subsequent outcomes key for future study design in this area
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01HL064857-01A1 | NIH | None | httpsreporternihgovquickSearch1U01HL064857-01A1 |