Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006401
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2000-10-12
Brief Title:
Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Inhaled NO for the Prevention of Chronic Lung Disease
Status:
COMPLETED
Status Verified Date:
2015-10
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:
To determine whether or not inhaled nitric oxide iNO safely decreases the incidence of chronic lung disease CLD in premature infants
Detailed Description:
BACKGROUND
Despite advances in medical nursing and respiratory care CLD affects up to 50 percent of premature infants As a result nearly 50000 infants in the United States develop CLD It is desirable to investigate therapies that decrease the incidence of CLD because it is associated with failure to thrive developmental delay increased risk of pulmonary infection reactive airway disease pulmonary hypertension and death
DESIGN NARRATIVE
This is a randomized double-blind placebo-controlled multi-center study Three specific hypotheses will be tested 1 iNO reduces the incidence of CLD 2 iNO reduces serum and lung tracheal aspirate markers of inflammation and 3 iNO does not increase the incidence of intraventricular hemorrhage in premature neonates The primary endpoint is survival without CLD defined as continued oxygen requirement at 36 weeks post conceptional age
A total of 793 premature newborns will be enrolled from 14 centers within 48 hours of birth They will be randomly assigned to receive either placebo or iNO at 5 ppm until the breathing tube can be safely removed or after 21 days The iNO will be delivered by an INOvent delivery system in such a way that physicians and nurses will not know which treatment each participant is receiving Management strategies for aspects of patient care including mechanical ventilation surfactant administration fluid administration and steroid use will be determined by physicians at each center Serial cranial ultrasounds and methemoglobin levels will be monitored to determine adverse events The first 200 patients will have serial blood samples and tracheal aspirates obtained for measurements of inflammatory mediators including interleukin-6 IL-6 interleukin-8 IL-8 interleukin-10 IL-10 endothelin-1 myeloperoxidase neutrophil counts tracheal aspirates and endothelin-1 blood Participants will be seen at 12 and 24 months of age to monitor the long-term effects on the cardiopulmonary or neurologic systems At these visits a health questionnaire will be administered and Bayley II scales of infant development will be completed
Despite advances in medical nursing and respiratory care CLD affects up to 50 percent of premature infants As a result nearly 50000 infants in the United States develop CLD It is desirable to investigate therapies that decrease the incidence of CLD because it is associated with failure to thrive developmental delay increased risk of pulmonary infection reactive airway disease pulmonary hypertension and death
DESIGN NARRATIVE
This is a randomized double-blind placebo-controlled multi-center study Three specific hypotheses will be tested 1 iNO reduces the incidence of CLD 2 iNO reduces serum and lung tracheal aspirate markers of inflammation and 3 iNO does not increase the incidence of intraventricular hemorrhage in premature neonates The primary endpoint is survival without CLD defined as continued oxygen requirement at 36 weeks post conceptional age
A total of 793 premature newborns will be enrolled from 14 centers within 48 hours of birth They will be randomly assigned to receive either placebo or iNO at 5 ppm until the breathing tube can be safely removed or after 21 days The iNO will be delivered by an INOvent delivery system in such a way that physicians and nurses will not know which treatment each participant is receiving Management strategies for aspects of patient care including mechanical ventilation surfactant administration fluid administration and steroid use will be determined by physicians at each center Serial cranial ultrasounds and methemoglobin levels will be monitored to determine adverse events The first 200 patients will have serial blood samples and tracheal aspirates obtained for measurements of inflammatory mediators including interleukin-6 IL-6 interleukin-8 IL-8 interleukin-10 IL-10 endothelin-1 myeloperoxidase neutrophil counts tracheal aspirates and endothelin-1 blood Participants will be seen at 12 and 24 months of age to monitor the long-term effects on the cardiopulmonary or neurologic systems At these visits a health questionnaire will be administered and Bayley II scales of infant development will be completed
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 |
|---|---|---|---|
| U01HL064857 | NIH | None | httpsreporternihgovquickSearchU01HL064857 |