Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005773
Status:
TERMINATED
Last Update Posted:
2017-09-26
First Post:
2000-06-01
Brief Title:
Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Early Inhaled Nitric Oxide Therapy in Term and Near Term Infants With Respiratory Failure
Status:
TERMINATED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Halted after 3 years because of a persistent decline in enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Early iNO
Brief Summary:
This prospective randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of extracorporeal membrane oxygenation ECMO -- temporary lung bypass -- therapy compared with the standard recommendation threshold Infants who were born at 34 weeks gestation were enrolled when they required assisted ventilation and had an oxygenation index OI 15 and 25 on any 2 measurements in a 12-hour interval Infants were randomized to receive either early iNO or to simulated initiation of iNO control Infants who had an increase in OI to 25 or more were given iNO as standard therapy The neurodevelopment of the subjects were evaluated at 18-22 months corrected age
Detailed Description:
Respiratory failure occurs in near term and term infants as a complication of perinatal aspiration syndromes pneumonia sepsis respiratory distress syndrome and primary pulmonary hypertension Recently a collaborative trial of the NICHD Neonatal Research Network and the Canadian Inhaled Nitric Oxide Study Group the NINOS trial demonstrated that inhaled nitric oxide iNO reduced the number of deaths and the need for extracorporeal membrane oxygenation ECMO therapy -- a lung bypass mechanism -- from 64 percent to 46 percent The standard recommended threshold for initiation of iNO therapy based on this trial was an oxygenation index OI 25
The purpose of this study is to determine if administration of inhaled nitric oxide earlier in the course of respiratory failure and to infants with less severe respiratory failure decreases the incidence of ECMO or death as suggested by the sub-group analysis of the original NINOS trial This prospective randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of ECMO therapy compared with the standard recommendation threshold
Infants who were born at 34 weeks gestation near- or full-term were enrolled when they required assisted ventilation and had an oxygenation index OI 15 and 25 on any 2 measurements in a 12-hour interval Infants were randomized to receive either early iNO or to simulated initiation of iNO control Infants who had an increase in OI to 25 or more were given iNO as standard therapy The neurodevelopment of the subjects were evaluated at 18-22 months corrected age
The study compared the outcome of infants received iNO at OI 15 and 25 with a control group that received a simulated early procedure with iNO actually given based on the standard recommendation iNO was delivered at 20 ppm during the initial dose-response evaluation Infants in either group who showed subsequent deterioration with OI 25 on two consecutive measurements at least one hour apart or a rapid deterioration with OI 30 on two consecutive measurements 15 minutes apart received iNO therapy as part of standard medical management Specific guidelines were followed for the use of high frequency ventilation and surfactant during study gas administration to prevent them from confounding the results of the study
Study recruitment was discontinued after 3 years due to a persistent decline in enrollment
Infants were given neurodevelopmental exams at 18-22 months corrected age
The purpose of this study is to determine if administration of inhaled nitric oxide earlier in the course of respiratory failure and to infants with less severe respiratory failure decreases the incidence of ECMO or death as suggested by the sub-group analysis of the original NINOS trial This prospective randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of ECMO therapy compared with the standard recommendation threshold
Infants who were born at 34 weeks gestation near- or full-term were enrolled when they required assisted ventilation and had an oxygenation index OI 15 and 25 on any 2 measurements in a 12-hour interval Infants were randomized to receive either early iNO or to simulated initiation of iNO control Infants who had an increase in OI to 25 or more were given iNO as standard therapy The neurodevelopment of the subjects were evaluated at 18-22 months corrected age
The study compared the outcome of infants received iNO at OI 15 and 25 with a control group that received a simulated early procedure with iNO actually given based on the standard recommendation iNO was delivered at 20 ppm during the initial dose-response evaluation Infants in either group who showed subsequent deterioration with OI 25 on two consecutive measurements at least one hour apart or a rapid deterioration with OI 30 on two consecutive measurements 15 minutes apart received iNO therapy as part of standard medical management Specific guidelines were followed for the use of high frequency ventilation and surfactant during study gas administration to prevent them from confounding the results of the study
Study recruitment was discontinued after 3 years due to a persistent decline in enrollment
Infants were given neurodevelopmental exams at 18-22 months corrected age
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 |
|---|---|---|---|
| M01RR016587 | NIH | None | httpsreporternihgovquickSearchM01RR016587 |
| U01HD019897 | NIH | None | None |
| U10HD021364 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD021415 | 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 |
| U10HD040689 | NIH | None | None |
| M01RR000070 | NIH | None | None |
| M01RR000633 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| M01RR000997 | NIH | None | None |
| M01RR001032 | NIH | None | None |
| M01RR006022 | NIH | None | None |
| M01RR008084 | NIH | None | None |