Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016523
Status:
TERMINATED
Last Update Posted:
2017-09-26
First Post:
2001-05-14
Brief Title:
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
Status:
TERMINATED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Preliminary results showed increased intraventricular hemorrhage IVH in experimental arm
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Preemie iNO
Brief Summary:
This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants less than 34 weeks gestational age with severe lung disease
Detailed Description:
This multicenter randomized double-masked controlled clinical trial evaluated the efficacy of inhaled nitric oxide iNO in the treatment of the preterm infant with respiratory failure secondary to respiratory distress syndrome RDS sepsispneumonia aspiration syndrome idiopathic pulmonary hypertension andor suspected pulmonary hypoplasia
Infants were followed until death or discharge to home The trial compared iNO therapy to mock gas delivery as the control and otherwise incorporated conventional management strategies including treatment with surfactant and high frequency ventilation as adjuncts to iNO therapy
During the initial dosing iNO was started at 5 ppm and could be increased to 10 ppm If the infant did not respond study gas was discontinued For infants who responded to study gas a gradual weaning was initiated The total exposure to study gas did not exceed 336 hours 14 days Infants were monitored for signs of toxicity
Medical and neurodevelopmental outcome of surviving infants were assessed at 18 to 22 months corrected age by masked certified examiners
Infants were followed until death or discharge to home The trial compared iNO therapy to mock gas delivery as the control and otherwise incorporated conventional management strategies including treatment with surfactant and high frequency ventilation as adjuncts to iNO therapy
During the initial dosing iNO was started at 5 ppm and could be increased to 10 ppm If the infant did not respond study gas was discontinued For infants who responded to study gas a gradual weaning was initiated The total exposure to study gas did not exceed 336 hours 14 days Infants were monitored for signs of toxicity
Medical and neurodevelopmental outcome of surviving infants were assessed at 18 to 22 months corrected age by masked certified examiners
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 |
|---|---|---|---|
| U10HD034216 | NIH | None | None |
| M01RR000032 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD027853 | NIH | None | None |
| M01RR008084 | NIH | None | None |
| U10HD027856 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| M01RR016587 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| M01RR000070 | NIH | None | None |
| U10HD040689 | NIH | None | None |
| M01RR000633 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD027871 | NIH | None | None |
| M01RR006022 | NIH | None | None |
| U10HD040498 | NIH | None | None |
| M01RR007122 | NIH | None | None |
| U10HD040461 | NIH | None | None |
| U10HD040521 | NIH | None | None |
| M01RR000044 | NIH | None | httpsreporternihgovquickSearchM01RR000044 |