Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00000548 |
| Other study ID # |
92 |
| Secondary ID |
U01HL062514 |
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
October 27, 1999 |
| Last updated |
March 3, 2015 |
| Start date |
March 2000 |
| Est. completion date |
February 2006 |
Study information
| Verified date |
March 2015 |
| Source |
University of California, San Francisco |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical Trial 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.
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.
