Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041548
Status:
TERMINATED
Last Update Posted:
2016-10-19
First Post:
2002-07-10
Brief Title:
Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow enrollment
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 pilot study is to evaluate whether administration of nitric oxide NOgas by oxygen hood at 20 ppm significantly increases PaO2 as compared to placebo gas oxygen within one hour of initiation and with no significant adverse effects
Detailed Description:
It is possible that administration of inhaled NO to neonates with abnormal gas exchange earlier rather than later as a rescue therapy in a moribund state might accelerate the transition of the circulation from the fetal to neonatal physiology and improve oxygenation This may in turn decrease the need for mechanical ventilation its associated morbidity and perhaps even ECMO
This study is designed as a pilot study to evaluate the physiologic efficacy rather than effect on clinical outcomes of NO administered by hood in improving oxygenation of neonates with elevated A-a DO2
This study is designed as a pilot study to evaluate the physiologic efficacy rather than effect on clinical outcomes of NO administered by hood in improving oxygenation of neonates with elevated A-a DO2
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