NCT05986032

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
5 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

July 19, 2023

Last Update Submit

March 5, 2024

Conditions

Bronchopulmonary Dysplasia

Keywords

Respiratory oscillometryRespiratory system reactanceLung mechanicsInfant lung function testing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O

    Xrs will be measured at 7 days of life

Other Outcomes (2)

  • Respiratory support mode

    7 postnatal days

  • Fraction of inspired oxygen

    7 days of life

Study Arms (2)

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

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

Interventions

Respiratory OscillometryDIAGNOSTIC_TEST

Measurement of respiratory system reactance by respiratory oscillometry

bronchopulmonary dysplasiano bronchopulmonary dysplasia

Eligibility Criteria

Age5 Days - 9 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • born before 32 weeks post-menstrual age

You may not qualify if:

  • congenital abnormalities
  • Inherited disorders of metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

ENROLLING BY INVITATION

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, 20900, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

ENROLLING BY INVITATION

Amsterdam UMC

Amsterdam, Netherlands

ENROLLING BY INVITATION

Uppsala University Children's Hospital

Uppsala, S-751 85, Sweden

ENROLLING BY INVITATION

Universitäts-Kinderspital beider Basel

Basel, 4056, Switzerland

ENROLLING BY INVITATION

Related Publications (2)

  • 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.

    PMID: 31108499BACKGROUND

  • 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.

    PMID: 30127523BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Camilla Rigotti, PhD

    Fondazione IRCCS San Gerardo dei Tintori

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Rigotti, PhD

CONTACT

+39039233dr.camilla.rigotti@gmail.com

Emanuela Zannin, PhD

CONTACT

+393389323437emanuela.zannin@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 14, 2023

Study Start

July 15, 2023

Primary Completion

September 3, 2024

Study Completion

September 24, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)NL(1)SE(1)IT(2)AU(1)