Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia

NCT ID: NCT05986032

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-15

Study Completion Date

2024-09-24

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchopulmonary Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Respiratory Oscillometry

Intervention Type DIAGNOSTIC_TEST

Measurement of respiratory system reactance by respiratory oscillometry

bronchopulmonary dysplasia

Group of patients developing bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-menstrual age.

Respiratory Oscillometry

Intervention Type DIAGNOSTIC_TEST

Measurement of respiratory system reactance by respiratory oscillometry

Interventions

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Respiratory Oscillometry

Measurement of respiratory system reactance by respiratory oscillometry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* born before 32 weeks post-menstrual age

Exclusion Criteria

* congenital abnormalities
* Inherited disorders of metabolism
Minimum Eligible Age

5 Days

Maximum Eligible Age

9 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role collaborator

University Children's Hospital Basel

OTHER

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role collaborator

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

OTHER

Sponsor Role collaborator

Fondazione IRCCS San Gerardo dei Tintori

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camilla Rigotti, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS San Gerardo dei Tintori

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status ENROLLING_BY_INVITATION

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, Italy

Site Status RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status ENROLLING_BY_INVITATION

Amsterdam UMC

Amsterdam, , Netherlands

Site Status ENROLLING_BY_INVITATION

Uppsala University Children's Hospital

Uppsala, , Sweden

Site Status ENROLLING_BY_INVITATION

Universitäts-Kinderspital beider Basel

Basel, , Switzerland

Site Status ENROLLING_BY_INVITATION

Countries

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Austria Italy Netherlands Sweden Switzerland

Central Contacts

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Camilla Rigotti, PhD

Role: CONTACT

+39039233 ext. 9173

Emanuela Zannin, PhD

Role: CONTACT

+393389323437

Facility Contacts

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Camilla Rigotti, PhD

Role: primary

+39039233 ext. 9173

References

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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.

Reference Type BACKGROUND
PMID: 31108499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30127523 (View on PubMed)

Other Identifiers

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REACT

Identifier Type: -

Identifier Source: org_study_id

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