Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005683
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2000-05-25
Brief Title:
Clinical Interventions in Respiratory Distress Syndrome and Neonatal Lung Injury - SCOR in Lung Biology and Diseases in Infants and Children
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-01
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 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
Detailed 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 trialsstudies 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 andor 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
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 trialsstudies 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 andor 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
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 |
|---|---|---|---|
| P50HL036543 | NIH | None | httpsreporternihgovquickSearchP50HL036543 |