Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005683 |
| Other study ID # |
4094 |
| Secondary ID |
P50HL036543 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
January 14, 2016 |
| Start date |
December 1986 |
| Est. completion date |
November 1997 |
Study information
| Verified date |
January 2016 |
| Source |
University of Rochester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To conduct clinical interventions directed at neonatal lung disease and injury, with a focus
on infants having surfactant-deficiency or inactivation as a component of pathophysiology. A
major emphasis was on the surfactant-deficient Respiratory Distress Syndrome (RDS) of
premature infants, and on acute neonatal respiratory failure in term infants with pulmonary
edema and potential surfactant inactivation (ARDS-related).
Description:
BACKGROUND:
The study was a subproject within a Specialized Center of Research (SCOR) in Lung Biology
and Diseases in Infants and Children. The clinical interventions studied had significance
for respiratory distress syndrome of the newborn and for bronchopulmonary dysplasia, which
is the chronic lung disorder of fibrosis, alveolar loss and reactive airway disease that
often follows pulmonary disease requiring treatment with oxygen and mechanical ventilation
in the newborn period.
DESIGN NARRATIVE:
A series of randomized, controlled trials/studies were conducted. In the first clinical
study, full term infants with severe respiratory pathology where surfactant inactivation was
important were assigned randomly to exogenous surfactant versus control groups to determine
if surfactant was efficacious and safe in this kind of lung injury. In the second study,
infants of less than 29 weeks gestation received prophylactic exogenous surfactant, but were
assigned randomly to receive it immediately following birth or after initial stabilization
at 10-15 minutes, to address a then critical current issue in surfactant therapy for RDS. In
the third study, infants who had moderate RDS despite exogenous surfactant therapy were
randomly assigned to high frequency jet or conventional ventilation groups to determine if
this mode of ventilation therapy would reduce barotrauma and the incidence and/or severity
of bronchopulmonary dysplasia (BPD). In addition to these three clinical trials, another
study involved therapy using superoxide dismutase (SOD) along with surfactant as a
multi-modal approach treating premature infants with RDS and lung injury secondary to
hyperoxia and mechanical ventilation. This study depended on results of animal studies with
SOD in Project 5. Finally, the study addressed the long term evaluation and surveillance of
survival, rehospitalizations, health status, pulmonary sequelae, and school performance of
those infants enrolled in the randomized clinical trials, as necessary for long-term outcome
assessments.
