Bronchopulmonary DysplasiaREACTNCT05986032
Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia, run by Fondazione IRCCS San Gerardo dei Tintori at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 9 days
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Respiratory Oscillometry
- How many people
- 150 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 15 Jul 2023to 24 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants will be recruited from those admitted to tertiary-level neonatal intensive care units.
Who may be able to join
- born before 32 weeks post-menstrual age
Who cannot join
- congenital abnormalities
- Inherited disorders of metabolism
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Italy2 sites, 2 recruiting
- Enrolling by invitation
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza E Brianza, 20900
Camilla Rigotti, PhD, +39039233 ext. 9173, dr.camilla.rigotti@gmail.com
Austria1 site, 1 recruiting
- Enrolling by invitation
Medical University of Vienna
Vienna, State of Vienna, 1090
Netherlands1 site, 1 recruiting
- Enrolling by invitation
Amsterdam UMC
Amsterdam
Sweden1 site, 1 recruiting
- Enrolling by invitation
Uppsala University Children's Hospital
Uppsala, S-751 85
Switzerland1 site, 1 recruiting
- Enrolling by invitation
Universitäts-Kinderspital beider Basel
Basel, 4056
About this study
Official title: Relationship Between Respiratory System Reactance Assessed by Respiratory Oscillometry and Respiratory Outcomes in Very Preterm Infants
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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Respiratory Oscillometry
- Keywords
- Respiratory oscillometry, Respiratory system reactance, Lung mechanics, Infant lung function testing
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory OscillometryDiagnostic test
Measurement of respiratory system reactance by respiratory oscillometry
| Study group | Role | What they receive |
|---|---|---|
| no bronchopulmonary dysplasia | Group of patients who do not receive the diagnosis of bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-mentrual age Receives: Diagnostic Test: Respiratory Oscillometry | |
| bronchopulmonary dysplasia | Group of patients developing bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-menstrual age. Receives: Diagnostic Test: Respiratory Oscillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure
Xrs will be expressed in z-score using reference equation for very preterm infants
Measured: Xrs will be measured at 7 days of life
Secondary outcomes (1)
Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O
Xrs will be expressed in cmH2O*S/L
Measured: Xrs will be measured at 7 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Jul 2023
- Primary completion3 Sep 2024 (estimated)
- Study completion24 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS San Gerardo dei Tintori
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University Children's Hospital Basel, Uppsala University Hospital, Medical University of Vienna, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Responsible party
- Sponsor
- Investigators
- Camilla Rigotti, PhD, Principal investigator, Fondazione IRCCS San Gerardo dei Tintori
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986032
- Sponsor's protocol ID
- REACT
- Acronym
- REACT
- Status last verified
- Mar 2024
- First submitted
- 19 Jul 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 31108499Veneroni 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.
PubMed 30127523
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Respiratory System Reactance Assessed by Respiratory Oscillometry and Respiratory Outcomes in Very Preterm Infants
- ClinicalTrials.gov ID
- NCT05986032
- Acronym / sponsor ID
- REACT / REACT
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Respiratory oscillometry, Respiratory system reactance, Lung mechanics, Infant lung function testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione IRCCS San Gerardo dei TintoriUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University Children's Hospital Basel, Uppsala University Hospital, Medical University of Vienna, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 3 Sep 2024 (estimated)
- Study completion
- 24 Sep 2024 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no bronchopulmonary dysplasia | – | Diagnostic Test: Respiratory OscillometryGroup of patients who do not receive the diagnosis of bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-mentrual age |
| bronchopulmonary dysplasia | – | Diagnostic Test: Respiratory OscillometryGroup of patients developing bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-menstrual age. |
Who may qualify
- Ages
- 5 to 9 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants will be recruited from those admitted to tertiary-level neonatal intensive care units.
Key inclusion criteria (1 listed)
- born before 32 weeks post-menstrual age
Key exclusion criteria (2 listed)
- congenital abnormalities
- Inherited disorders of metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory OscillometryMeasurement of respiratory system reactance by respiratory oscillometry | Diagnostic test | bronchopulmonary dysplasia, no bronchopulmonary dysplasia |
Primary outcome
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
1 secondary outcome
Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O
Time frame: Xrs will be measured at 7 days of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 31108499Zannin 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.
- Background: PubMed 30127523Veneroni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camilla Rigotti, PhD principal investigator
Fondazione IRCCS San Gerardo dei Tintori
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by Fondazione IRCCS San Gerardo dei Tintori at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Austria, Netherlands, Sweden, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camilla Rigotti, PhD (+39039233 ext. 9173, dr.camilla.rigotti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure (time frame: Xrs will be measured at 7 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05986032, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.