LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS | NCT06394583

Studies
LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS

NCT06394583

Sponsor

Andaluz Health Service

Status

Not yet recruiting

Last Update Posted

May 1, 2024Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Extremely Low Birth Weight Infants
Respiratory Distress Syndrome, Newborn

Interventions

Lung ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2024Estimated

Primary Completion Date

Jun 1, 2029Estimated

Completion Date

Dec 1, 2029Estimated

First Submitted Date

Apr 28, 2024

First Submission Date that Met QC Criteria

Apr 30, 2024

First Posted Date

May 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2024

Last Update Posted Date

May 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung ultrasound	Procedure	We will perform a LU at birth to all infants, before the first dose of surfactant.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Description of LU patterns		at birth

Secondary Outcomes

Measure	Description	Time Frame
need of IMV		during NICU admission
length of IMV		during NICU admission
length of NIV

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012127	Respiratory Distress Syndrome, Newborn
D047928	Premature Birth

Ancestor Terms

ID	Term
D012128	Respiratory Distress Syndrome
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided