Status:
NOT_YET_RECRUITING
Prevention of Chronic Lung Disease (CLD - Prevention Study)
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Azienda Ospedaliero-Universitaria di Parma
Conditions:
Chronic Lung Disease
Eligibility:
All Genders
1-24 years
Phase:
NA
Brief Summary
Primary endpoint: \- prospectively identify potential biomarkers able to predict the severe course of pulmonary funcion in the first 12 months of life and realize a new profile to early identify hugh...
Detailed Description
Background Chronic Lung Disease (CLD) is one of the most common complications of perinatal lung injury which represents a systemic condition with long term sequelae, such as persistent pulmonary dysfu...
Eligibility Criteria
Inclusion
- Infants with gestational age \< 32 weeks with at least one of the following signs of acute respiratory failure within the first 24 hours of life:
- need for mechanical ventilation;
- need for noninvasive respiratory support;
- need for oxygen administration;
- need for surfactant administration
Exclusion
- Congenital malformations
- Neuromuscular diseases.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06559670
Start Date
September 1 2024
End Date
September 1 2026
Last Update
August 19 2024
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Neonatologia
Rome, RM, Italy, 00168