NCT06394583

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
43mo left

Started Jun 2024

Longer than P75 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Jun 2024Dec 2029

First Submitted

Initial submission to the registry

April 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 30, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

4.9 years

First QC Date

April 28, 2024

Last Update Submit

April 30, 2024

Conditions

Extremely Low Birth Weight InfantsRespiratory Distress Syndrome, Newborn

Keywords

lung ultrasoundpremature infantextremely low birth weight infants

Outcome Measures

Primary Outcomes (1)

  • Description of LU patterns

    at birth

Secondary Outcomes (3)

  • need of IMV

    during NICU admission

  • length of IMV

    during NICU admission

  • length of NIV

    during NICU admission

Interventions

Lung ultrasoundPROCEDURE

We will perform a LU at birth to all infants, before the first dose of surfactant.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornPremature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 1, 2024

Study Start

June 30, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

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