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Not yet recruitingNCT06394583MINI-LUSUpdated May 1, 2024

LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS

An observational study in Extremely Low Birth Weight Infants and Respiratory Distress Syndrome, Newborn, sponsored by Andaluz Health Service. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-05-01.

Sponsored by Andaluz Health Service · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
150
Sex
All
01

Study 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.

02

Conditions studied

  • Extremely Low Birth Weight Infants
  • Respiratory Distress Syndrome, Newborn

Keywords

  • lung ultrasound
  • premature infant
  • extremely low birth weight infants
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Andaluz Health Service is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • received surfactant before LU
  • redirection of care
  • severe malformations of cromosomopathies
  • unable to perform LU
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • ProcedureLung ultrasound

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

06

What researchers measure

Primary outcomes

  1. Description of LU patterns

    Time frame: at birth

Secondary outcomes

  1. need of IMV

    Time frame: during NICU admission

  2. length of IMV

    Time frame: during NICU admission

  3. length of NIV

    Time frame: during NICU admission

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Each investigator will review only the data from their own hospital.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06394583
Lead sponsor
Andaluz Health Service
Responsible party
Almudena Alonso Ojembarrena (MD, PhD, Andaluz Health Service) — Principal investigator
First posted
May 1, 2024
Start date
Jun 30, 2024 (estimated)
Primary completion
Jun 1, 2029 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
May 1, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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