NCT05986032
Recruiting
N/A
Relationship Between Respiratory System Reactance Assessed by Respiratory Oscillometry and Respiratory Outcomes in Very Preterm Infants
Fondazione IRCCS San Gerardo dei Tintori6 sites in 5 countries150 target enrollmentJuly 15, 2023
ConditionsBronchopulmonary Dysplasia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bronchopulmonary Dysplasia
- Sponsor
- Fondazione IRCCS San Gerardo dei Tintori
- Enrollment
- 150
- Locations
- 6
- Primary Endpoint
- Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this observational study is to learn about the correlation between respiratory system reactance, as assessed by respiratory oscillometry, and respiratory outcomes in preterm infants born before 32 weeks of gestation. The main question it aims to answer is if the reactance z-score at 7 postnatal days adds to relevant clinical factors in the prediction of bronchopulmonary dysplasia. Participants will receive respiratory oscillometry measurements at 7 ± 2 postnatal days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •born before 32 weeks post-menstrual age
Exclusion Criteria
- •congenital abnormalities
- •Inherited disorders of metabolism
Outcomes
Primary Outcomes
Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure
Time Frame: Xrs will be measured at 7 days of life
Xrs will be expressed in z-score using reference equation for very preterm infants
Secondary Outcomes
- Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O(Xrs will be measured at 7 days of life)
Study Sites (6)
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