Extremely Low Birth Weight InfantsMINI-LUSNCT06394583
LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS
An observational study of Extremely Low Birth Weight Infants and Respiratory Distress Syndrome, Newborn, run by Andaluz Health Service.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extremely Low Birth Weight Infants, Respiratory Distress Syndrome, Newborn
- What is being tested?
- Lung ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 1 Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants born before 26 weeks in any of the centers included in the registry.
Who may be able to join
- Infants born before 26 weeks at any of the participant hospitals.
Who cannot join
- received surfactant before LU
- redirection of care
- severe malformations of cromosomopathies
- unable to perform LU
About this study
Official title: 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.
- Being tested
- Lung ultrasound
- Keywords
- lung ultrasound, premature infant, extremely low birth weight infants
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundProcedure or surgery
We will perform a LU at birth to all infants, before the first dose of surfactant.
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of LU patterns
Measured: at birth
Secondary outcomes (3)
need of IMV
Measured: during NICU admission
length of IMV
Measured: during NICU admission
length of NIV
Measured: during NICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start30 Jun 2024 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extremely Low Birth Weight InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Andaluz Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Almudena Alonso Ojembarrena, Andaluz Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394583
- Sponsor's protocol ID
- NEO-LUS-24-01
- Acronym
- MINI-LUS
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Each investigator will review only the data from their own hospital.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DESCRIPTION OF THE LUNG ULTRASOUND PATTERN IN INFANTS UNDER 26 WEEKS OF GESTATION: A NATIONAL MULTICENTER STUDY
- ClinicalTrials.gov ID
- NCT06394583
- Acronym / sponsor ID
- MINI-LUS / NEO-LUS-24-01
- Keywords
- lung ultrasound, premature infant, extremely low birth weight infants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Andaluz Health ServiceOther government
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born before 26 weeks in any of the centers included in the registry.
Key inclusion criteria (1 listed)
- Infants born before 26 weeks at any of the participant hospitals.
Key exclusion criteria (4 listed)
- received surfactant before LU
- redirection of care
- severe malformations of cromosomopathies
- unable to perform LU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundWe will perform a LU at birth to all infants, before the first dose of surfactant. | Procedure or surgery | – |
Primary outcome
Description of LU patterns
Time frame: at birth
3 secondary outcomes
need of IMV
Time frame: during NICU admission
length of IMV
Time frame: during NICU admission
length of NIV
Time frame: during NICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No. Each investigator will review only the data from their own hospital.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Extremely Low Birth Weight Infants and Respiratory Distress Syndrome, Newborn, run by Andaluz Health Service.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of LU patterns (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.