LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS (MINI-LUS)

April 30, 2024 updated by: Almudena Alonso Ojembarrena, Andaluz Health Service

DESCRIPTION OF THE LUNG ULTRASOUND PATTERN IN INFANTS UNDER 26 WEEKS OF GESTATION: A NATIONAL MULTICENTER STUDY

All infants born before 26 weeks born in a hospital included in the registry will receive a LU at birth, before the first dose of surfactant. We will register as well the length of IMV, NIV or the need of IMV in the whole sample.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infants born before 26 weeks in any of the centers included in the registry.

Description

Inclusion Criteria:

  • Infants born before 26 weeks at any of the participant hospitals.

Exclusion Criteria:

  • received surfactant before LU
  • redirection of care
  • severe malformations of cromosomopathies
  • unable to perform LU

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Description of LU patterns
Time Frame: at birth
at birth

Secondary Outcome Measures

Outcome Measure
Time Frame
need of IMV
Time Frame: during NICU admission
during NICU admission
length of IMV
Time Frame: during NICU admission
during NICU admission
length of NIV
Time Frame: during NICU admission
during NICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andaluz Health Service

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEO-LUS-24-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Each investigator will review only the data from their own hospital.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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