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Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia

Relationship Between Respiratory System Reactance Assessed by Respiratory Oscillometry and Respiratory Outcomes in Very Preterm Infants

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05986032
Acronym
REACT
Enrollment
150
Registered
2023-08-14
Start date
2023-07-15
Completion date
2024-09-24
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia

Keywords

Respiratory oscillometry, Respiratory system reactance, Lung mechanics, Infant lung function testing

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.

Interventions

Measurement of respiratory system reactance by respiratory oscillometry

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
CollaboratorOTHER
University Children's Hospital Basel
CollaboratorOTHER
Uppsala University Hospital
CollaboratorOTHER
Medical University of Vienna
CollaboratorOTHER
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
CollaboratorOTHER
Fondazione IRCCS San Gerardo dei Tintori
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Days to 9 Days
Healthy volunteers
No

Inclusion criteria

* born before 32 weeks post-menstrual age

Exclusion criteria

* congenital abnormalities * Inherited disorders of metabolism

Design outcomes

Primary

MeasureTime frameDescription
Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressureXrs will be measured at 7 days of lifeXrs will be expressed in z-score using reference equation for very preterm infants

Secondary

MeasureTime frameDescription
Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2OXrs will be measured at 7 days of lifeXrs will be expressed in cmH2O\*S/L

Other

MeasureTime frameDescription
Respiratory support mode7 postnatal daysRespiratory support mode will be coded as 0 = no respiratory support, 1 = nasal high flow therapy, 2 = nasal CPAP or nasal IPPV, 3 = invasive mechanical ventilation
Fraction of inspired oxygen7 days of life

Countries

Austria, Italy, Netherlands, Sweden, Switzerland

Contacts

Primary ContactCamilla Rigotti, PhD
dr.camilla.rigotti@gmail.com+39039233
Backup ContactEmanuela Zannin, PhD
emanuela.zannin@gmail.com+393389323437

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026