Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000548
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
1999-10-27
Brief Title:
Inhaled NO in Prevention of Chronic Lung Disease
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-03
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 test the hypothesis that low-dose inhaled nitric oxide administered to preterm infants who continue to require mechanical ventilation at 14 days of age will reduce the incidence of chronic lung disease
Detailed Description:
BACKGROUND
Respiratory morbidity particularly chronic lung disease CLD remains a major cause of long-term morbidity and mortality for preterm infants Although surfactant replacement has decreased acute respiratory morbidity and mortality it has not reduced the incidence of CLD A number of other approaches including antenatal thyrotropin releasing hormone in conjunction with corticosteroids postnatal steroid administration as well as administration of Vitamin E diuretics and bronchodilators have not resulted in clinically important decreases in CLD Infants with the most severe CLD go on to develop findings suggestive of pulmonary hypertension with cor pulmonale There is preliminary evidence in the preterm infant with severe chronic lung disease that low-dose inhaled nitric oxide may significantly attenuate the disease and decrease mortality
DESIGN NARRATIVE
The multi-center controlled and blinded trial investigates the hypothesis that low-dose inhaled nitric oxide administered to preterm infants between 500 and 1250 grams birth weight who continue to require mechanical ventilation at 10 days of age will increase survival without chronic lung disease CLD at 36 weeks post menstrual age Secondary outcomes are duration of ventilation oxygen requirement and duration of hospitalization In addition that there will be expected improvement in infant respiratory status ventilatory support airway resistance and compliance associated with inhaled nitric oxide treatment Indicators of inflammation and oxidant stress will be assessed by measurements of specific cytokines and protein modifications in tracheal aspirate and plasma samples respectively The safety of this therapy will be evaluated by assessing toxicity as measured by clinical bleeding including intraventricular hemorrhage as well as the incidence of other morbidities of the preterm infant necrotizing enterocolitis retinopathy of prematurity and infection and assessing neurodevelopmental outcome through two years of age A total of 480 infants were randomized to either inhaled NO or placebo In summary this clinical trial will assess the efficacy and safety of inhaled nitric oxide for amelioration of a major disease of premature infants
Respiratory morbidity particularly chronic lung disease CLD remains a major cause of long-term morbidity and mortality for preterm infants Although surfactant replacement has decreased acute respiratory morbidity and mortality it has not reduced the incidence of CLD A number of other approaches including antenatal thyrotropin releasing hormone in conjunction with corticosteroids postnatal steroid administration as well as administration of Vitamin E diuretics and bronchodilators have not resulted in clinically important decreases in CLD Infants with the most severe CLD go on to develop findings suggestive of pulmonary hypertension with cor pulmonale There is preliminary evidence in the preterm infant with severe chronic lung disease that low-dose inhaled nitric oxide may significantly attenuate the disease and decrease mortality
DESIGN NARRATIVE
The multi-center controlled and blinded trial investigates the hypothesis that low-dose inhaled nitric oxide administered to preterm infants between 500 and 1250 grams birth weight who continue to require mechanical ventilation at 10 days of age will increase survival without chronic lung disease CLD at 36 weeks post menstrual age Secondary outcomes are duration of ventilation oxygen requirement and duration of hospitalization In addition that there will be expected improvement in infant respiratory status ventilatory support airway resistance and compliance associated with inhaled nitric oxide treatment Indicators of inflammation and oxidant stress will be assessed by measurements of specific cytokines and protein modifications in tracheal aspirate and plasma samples respectively The safety of this therapy will be evaluated by assessing toxicity as measured by clinical bleeding including intraventricular hemorrhage as well as the incidence of other morbidities of the preterm infant necrotizing enterocolitis retinopathy of prematurity and infection and assessing neurodevelopmental outcome through two years of age A total of 480 infants were randomized to either inhaled NO or placebo In summary this clinical trial will assess the efficacy and safety of inhaled nitric oxide for amelioration of a major disease of premature infants
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL062514 | NIH | None | httpsreporternihgovquickSearchU01HL062514 |