Clinical trial NCT05986032: Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia
Official title: Relationship Between Respiratory System Reactance Assessed by Respiratory Oscillometry and Respiratory Outcomes in Very Preterm Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchopulmonary Dysplasia
Keywords: Respiratory oscillometry
Respiratory system reactance
Lung mechanics
Infant lung function testing
Lead sponsor: Fondazione IRCCS San Gerardo dei Tintori
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: University Children's Hospital Basel
name: Uppsala University Hospital
name: Medical University of Vienna
name: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
First posted: 2023-08-14
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants will be recruited from those admitted to tertiary-level neonatal intensive care units.

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.


Eligibility criteria: Inclusion Criteria:

* born before 32 weeks post-menstrual age

Exclusion Criteria:

* congenital abnormalities
* Inherited disorders of metabolism

Primary outcomes:
measure: Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure
timeFrame: Xrs will be measured at 7 days of life
Secondary outcomes:
measure: Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O
timeFrame: Xrs will be measured at 7 days of life
Other outcomes:
measure: Respiratory support mode
timeFrame: 7 postnatal days
measure: Fraction of inspired oxygen
timeFrame: 7 days of life
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
state: Wien
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
state: Monza E Brianza
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Uppsala
country: Sweden
facility: Uppsala University Children's Hospital
city: Basel
country: Switzerland
facility: Universitäts-Kinderspital beider Basel
Study officials:
affiliation: Fondazione IRCCS San Gerardo dei Tintori
name: Camilla Rigotti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zannin E, Neumann RP, Dellaca R, Schulzke SM. Forced oscillation measurements in the first week of life and pulmonary outcome in very preterm infants on noninvasive respiratory support. Pediatr Res. 2019 Sep;86(3):382-388. doi: 10.1038/s41390-019-0432-6. Epub 2019 May 20.
citation: Veneroni C, Wallstrom L, Sindelar R, Dellaca' RL. Oscillatory respiratory mechanics on the first day of life improves prediction of respiratory outcomes in extremely preterm newborns. Pediatr Res. 2019 Feb;85(3):312-317. doi: 10.1038/s41390-018-0133-6. Epub 2018 Aug 4.