Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005776
Status:
TERMINATED
Last Update Posted:
2017-09-26
First Post:
2000-06-01
Brief Title:
Inhaled Nitric Oxide Study for Respiratory Failure in Newborns
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
The Randomized Inhaled Nitric Oxide Study NINOS in Full-Term and Nearly Full-Term Infants With Hypoxic Respiratory Failure
Status:
TERMINATED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Results showed statistically significant benefit in the experimental group
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NINOS
Brief Summary:
Respiratory failure in term newborns is associated with increased rates of death and long-term neurodevelopmental problems This large international multicenter trial randomized newborns who had failed to respond to intensive care including high levels of ventilator support to receive either inhaled nitric oxide iNO or 100 percent oxygen to test whether iNO would decrease their risk of dying or requiring temporary lung bypass Infants were followed during their initial hospitalization their outcome was assessed at 18 to 24 mos of age
Detailed Description:
Respiratory failure in term newborns is associated with significant morbidity and mortality despite maximal conventional therapy Neonates with pulmonary hypertension have been treated with iNO a selective pulmonary vasodilator This multicenter double-masked placebo-controlled randomized trial tested whether iNO would reduce the risk of death andor the initiation of extracorporeal membrane oxygenation ECMO in a prospectively defined cohort of term or near-term neonates with hypoxic respiratory failure unresponsive to conventional therapy The sample size was based on a reduction of the primary event death or ECMO from 50 percent to 30 percent 90 percent power and a two-tailed Type I error of 005
Infants were evaluated at baseline for pulmonary cardiac bleeding status and therapies received Those who were greater than 34 wks gestation and 14 days old or less and required assisted ventilation with an OI mean airway pressure x FiO2 divided by the PaO2 x 100 greater than 25 were eligible They were randomly assigned to receive iNO at 20 ppm or 100 percent oxygen as a control Infants whose PaO2 increased by less than 20 mm Hg after 30 minutes were studied at 80ppm iNO or control gas MetHg and NO2 concentrations were monitored regularly Management including surfactant administration included prospectively defined criteria for study gas response escalation reinitiation and weaning The maximum total time on study gas was 336 hrs after 240 hrs the INO concentration was required to be no more than 5 ppm Patients were followed to death discharge or 120 days and evaluated at 18-24 mos by a masked certified examiner
Infants were evaluated at baseline for pulmonary cardiac bleeding status and therapies received Those who were greater than 34 wks gestation and 14 days old or less and required assisted ventilation with an OI mean airway pressure x FiO2 divided by the PaO2 x 100 greater than 25 were eligible They were randomly assigned to receive iNO at 20 ppm or 100 percent oxygen as a control Infants whose PaO2 increased by less than 20 mm Hg after 30 minutes were studied at 80ppm iNO or control gas MetHg and NO2 concentrations were monitored regularly Management including surfactant administration included prospectively defined criteria for study gas response escalation reinitiation and weaning The maximum total time on study gas was 336 hrs after 240 hrs the INO concentration was required to be no more than 5 ppm Patients were followed to death discharge or 120 days and evaluated at 18-24 mos by a masked certified examiner
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 |
|---|---|---|---|
| M01RR008084 | NIH | None | httpsreporternihgovquickSearchM01RR008084 |
| U01HD019897 | NIH | None | None |
| U10HD021364 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD021415 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD027853 | NIH | None | None |
| U10HD027856 | NIH | None | None |
| U10HD027871 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| U10HD027881 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD034167 | NIH | None | None |
| U10HD034216 | NIH | None | None |
| M01RR000070 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| M01RR000997 | NIH | None | None |
| M01RR001032 | NIH | None | None |
| M01RR006022 | NIH | None | None |