Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia

Recruiting

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Diagnostic Test: Respiratory Oscillometry

• Registration Number: NCT05986032
• Lead Sponsor: Fondazione IRCCS San Gerardo dei Tintori

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-15
• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-09-03
• Study Completion: 2024-09-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• born before 32 weeks post-menstrual age

Exclusion Criteria

• congenital abnormalities
• Inherited disorders of metabolism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no bronchopulmonary dysplasia	Respiratory Oscillometry	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
bronchopulmonary dysplasia	Respiratory Oscillometry	Group of patients developing bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-menstrual age.

Primary Outcome Measures

Name	Time	Method
Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure	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

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

Trial Locations

Locations (6)

Medical University of Vienna; 🇦🇹 Vienna, Wien, Austria

Universitäts-Kinderspital beider Basel; 🇨🇭 Basel, Switzerland

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

Fondazione IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, Monza E Brianza, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

Uppsala University Children's Hospital; 🇸🇪 Uppsala, Sweden