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NCT06394583 Clinical Trial

LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS

Respiratory Distress Syndrome, Newborn Clinical Trial

— MINI-LUS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06394583
Other study ID # NEO-LUS-24-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 30, 2024
Est. completion date December 1, 2029

Study information
Verified date April 2024
Source Andaluz Health Service
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date December 1, 2029
Est. primary completion date June 1, 2029
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Lung ultrasound
We will perform a LU at birth to all infants, before the first dose of surfactant.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Andaluz Health Service

Outcome
Type Measure Description Time frame Safety issue
Primary Description of LU patterns at birth
Secondary need of IMV during NICU admission
Secondary length of IMV during NICU admission
Secondary length of NIV during NICU admission
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