Using respiratory oscillometry to predict bronchopulmonary dysplasia in preterm infants
Relationship Between Respiratory System Reactance Assessed by Respiratory Oscillometry and Respiratory Outcomes in Very Preterm Infants
This study is testing if a breathing test can help predict lung problems in preterm babies born before 32 weeks to improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 5 Days to 9 Days |
| Sex | All |
| Sponsor | Fondazione IRCCS San Gerardo dei Tintori Academic / other |
| Locations | 6 sites (Vienna, Wien and 5 other locations) |
| Trial ID | NCT05986032 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between respiratory system reactance, measured through respiratory oscillometry, and respiratory outcomes in preterm infants born before 32 weeks of gestation. The primary focus is to determine if the reactance z-score at 7 postnatal days can enhance the prediction of bronchopulmonary dysplasia when combined with other clinical factors. Participants will undergo respiratory oscillometry assessments at approximately one week after birth to gather relevant data.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born before 32 weeks of gestation.
Not a fit: Patients with congenital abnormalities or inherited metabolic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve early prediction and management of bronchopulmonary dysplasia in vulnerable preterm infants.
How similar studies have performed: While this approach is relatively novel, similar studies have shown promise in using respiratory measurements to predict outcomes in preterm infants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * born before 32 weeks post-menstrual age Exclusion Criteria: * congenital abnormalities * Inherited disorders of metabolism
Where this trial is running
Vienna, Wien and 5 other locations
- Medical University of Vienna — Vienna, Wien, Austria (Enrolling_by_invitation)
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Monza E Brianza, Italy (Recruiting)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milano, Italy (Enrolling_by_invitation)
- Amsterdam UMC — Amsterdam, Netherlands (Enrolling_by_invitation)
- Uppsala University Children's Hospital — Uppsala, Sweden (Enrolling_by_invitation)
- Universitäts-Kinderspital beider Basel — Basel, Switzerland (Enrolling_by_invitation)
Study contacts
- Principal investigator: Camilla Rigotti, PhD — Fondazione IRCCS San Gerardo dei Tintori
- Study coordinator: Camilla Rigotti, PhD
- Email: dr.camilla.rigotti@gmail.com
- Phone: +39039233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.