The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia (REACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05986032
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : March 6, 2024
Sponsor:
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)
Information provided by (Responsible Party):
Fondazione IRCCS San Gerardo dei Tintori

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Bronchopulmonary Dysplasia Diagnostic Test: Respiratory Oscillometry

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship Between Respiratory System Reactance Assessed by Respiratory Oscillometry and Respiratory Outcomes in Very Preterm Infants
Actual Study Start Date : July 15, 2023
Estimated Primary Completion Date : September 3, 2024
Estimated Study Completion Date : September 24, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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
 Diagnostic Test: Respiratory Oscillometry
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.
 Diagnostic Test: Respiratory Oscillometry
Measurement of respiratory system reactance by respiratory oscillometry


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Xrs will be expressed in cmH2O*S/L


Other Outcome Measures:
  1. Respiratory support mode [ Time Frame: 7 postnatal days ]
    Respiratory 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

  2. Fraction of inspired oxygen [ Time Frame: 7 days of life ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Days to 9 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infants will be recruited from those admitted to tertiary-level neonatal intensive care units.
Criteria

Inclusion Criteria:

  • born before 32 weeks post-menstrual age

Exclusion Criteria:

  • congenital abnormalities
  • Inherited disorders of metabolism
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05986032


Contacts
Layout table for location contacts
Contact: Camilla Rigotti, PhD +39039233 ext 9173 dr.camilla.rigotti@gmail.com
Contact: Emanuela Zannin, PhD +393389323437 emanuela.zannin@gmail.com

Locations
Layout table for location information
Austria
Medical University of Vienna Enrolling by invitation
Vienna, Wien, Austria, 1090
Italy
Fondazione IRCCS San Gerardo dei Tintori Recruiting
Monza, Monza E Brianza, Italy, 20900
Contact: Camilla Rigotti, PhD    +39039233 ext 9173    dr.camilla.rigotti@gmail.com   
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Enrolling by invitation
Milano, Italy, 20122
Netherlands
Amsterdam UMC Enrolling by invitation
Amsterdam, Netherlands
Sweden
Uppsala University Children's Hospital Enrolling by invitation
Uppsala, Sweden, S-751 85
Switzerland
Universitäts-Kinderspital beider Basel Enrolling by invitation
Basel, Switzerland, 4056
Sponsors and Collaborators
Fondazione IRCCS San Gerardo dei Tintori
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)
Investigators
Layout table for investigator information
Principal Investigator: Camilla Rigotti, PhD Fondazione IRCCS San Gerardo dei Tintori
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Fondazione IRCCS San Gerardo dei Tintori
ClinicalTrials.gov Identifier: NCT05986032    
Other Study ID Numbers: REACT
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fondazione IRCCS San Gerardo dei Tintori:
Respiratory oscillometry
Respiratory system reactance
Lung mechanics
Infant lung function testing
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
 Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases