Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia (REACT)

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchopulmonary Dysplasia
• Intervention / Treatment: Diagnostic test: Respiratory Oscillometry

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Camilla Rigotti, PhD; Phone Number: 9173 +39039233; Email: dr.camilla.rigotti@gmail.com
• Study Contact Backup: Name: Emanuela Zannin, PhD; Phone Number: +393389323437; Email: emanuela.zannin@gmail.com

Study Locations

• Austria
  • Wien
    • Vienna, Wien, Austria, 1090
      • Enrolling by invitation
      • Medical University of Vienna
• Italy
  • Milano, Italy, 20122
    • Enrolling by invitation
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Monza E Brianza
    • Monza, Monza E Brianza, Italy, 20900
      • Recruiting
      • Fondazione IRCCS San Gerardo dei Tintori
      • Contact: Camilla Rigotti, PhD; Phone Number: 9173 +39039233; Email: dr.camilla.rigotti@gmail.com
• Netherlands
  • Amsterdam, Netherlands
    • Enrolling by invitation
    • Amsterdam UMC
• Sweden
  • Uppsala, Sweden, S-751 85
    • Enrolling by invitation
    • Uppsala University Children's Hospital
• Switzerland
  • Basel, Switzerland, 4056
    • Enrolling by invitation
    • Universitäts-Kinderspital beider Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Infants will be recruited from those admitted to tertiary-level neonatal intensive care units.

Description

Inclusion Criteria:

• born before 32 weeks post-menstrual age

Exclusion Criteria:

• congenital abnormalities
• Inherited disorders of metabolism

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Xrs will be measured at 7 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O	Xrs will be expressed in cmH2O*S/L	Xrs will be measured at 7 days of life

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory support mode	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	7 postnatal days
Fraction of inspired oxygen		7 days of life

Collaborators and Investigators

• Sponsor: Fondazione IRCCS San Gerardo dei Tintori
• Collaborators: Medical University of Vienna; Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Uppsala University Hospital; University Children's Hospital Basel; Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
• Investigators: Principal Investigator: Camilla Rigotti, PhD, Fondazione IRCCS San Gerardo dei Tintori

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Estimated): September 3, 2024
• Study Completion (Estimated): September 24, 2024

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lung mechanics; Respiratory system reactance; Respiratory oscillometry; Infant lung function testing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia
• Other Study ID Numbers: REACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO