PretermsNCT05918016
Ultrasonographic Prognostic Scale of Periventricular Hemorrhagic Infarction
An observational study of Preterms and Infarction Cerebral, run by Manuel Sanchez Luna at 1 site in Spain.
Trial summary
Observational study of preterm infant with a gestational age < 30 weeks born between 2017-2023 in Neonatal Care Unit in Gregorio Marañon Hospital (Madrid, Spain). We use a new ultrasonographic prognostic scale of periventricular hemorrhagic infarction for neurodevelopmental outcome at age 2 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterms, Infarction Cerebral
- What is being tested?
- Routine cranial ultrasounds
- How many people
- 360 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2017to 1 Oct 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Newborn with gestational age < 30 weeks
Who may be able to join
- Gestacional Age < 30 weeks
Who cannot join
- Brain malformation
- Genetic syndrome
- Metabolic disorders
- Chromosomal abnormality
- None cranial ultrasound
Trial locations and contacts
1 site in 1 country.
Manuel Sánchez Luna, Doctor contact
Spain1 site, 1 recruiting
- Recruiting
Gregorio Marañon Hospital
Madrid, 28007
Manuel Sanchez Luna, Doctor, msluna@salud.madrid.org
About this study
Official title: Ultrasonographic Prognostic Scale of Periventricular Hemorrhagic Infarction in Preterm Infants With Gestational Age <30 Weeks
Observational study of preterm infant with a gestational age < 30 weeks born between 2017-2023 in Neonatal Care Unit in Gregorio Marañon Hospital (Madrid, Spain). We use a new ultrasonographic prognostic scale of periventricular hemorrhagic infarction for neurodevelopmental outcome at age 2 years.
- Conditions
- Preterms, Infarction Cerebral
- Being tested
- Routine cranial ultrasounds
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine cranial ultrasoundsDiagnostic test
we will use the routine cranial ultrasounds
What is being measured
The primary outcome is the main question the study is designed to answer.
Periventricular Hemorrhagic Infarction
Yes or no
Measured: first month
Characteristic Sonographic
Measured: first month
Neurodevelopmental outcome at age 2 years
Measured: first month
Secondary outcomes (1)
Medical records
Measured: first month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study startJan 2017
- Primary completion31 Jul 2023 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermsStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 360 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Manuel Sanchez Luna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918016
- Sponsor's protocol ID
- Neuro.Neo.1.IVH
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Prognostic Scale of Periventricular Hemorrhagic Infarction in Preterm Infants With Gestational Age <30 Weeks
- ClinicalTrials.gov ID
- NCT05918016
- Acronym / sponsor ID
- Neuro.Neo.1.IVH
- Conditions
- Preterms, Infarction Cerebral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Manuel Sanchez LunaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 26 Jun 2023 (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.
Observational study of preterm infant with a gestational age < 30 weeks born between 2017-2023 in Neonatal Care Unit in Gregorio Marañon Hospital (Madrid, Spain). We use a new ultrasonographic prognostic scale of periventricular hemorrhagic infarction for neurodevelopmental outcome at age 2 years.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newborn with gestational age < 30 weeks
Key inclusion criteria (1 listed)
- Gestacional Age < 30 weeks
Key exclusion criteria (5 listed)
- Brain malformation
- Genetic syndrome
- Metabolic disorders
- Chromosomal abnormality
- None cranial ultrasound
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 |
|---|---|---|
| Routine cranial ultrasoundswe will use the routine cranial ultrasounds | Diagnostic test | – |
Primary outcome
Periventricular Hemorrhagic Infarction
Time frame: first month
Yes or no
Characteristic Sonographic
Time frame: first month
Neurodevelopmental outcome at age 2 years
Time frame: first month
1 secondary outcome
Medical records
Time frame: first month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Manuel Sánchez Luna, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterms and Infarction Cerebral, run by Manuel Sanchez Luna at 1 site in Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Sánchez Luna, Doctor (msluna@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periventricular Hemorrhagic Infarction (time frame: first month). The study lists 3 primary outcomes in all. 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 26 Jun 2023.