Ultrasonographic Prognostic Scale of Periventricular Hemorrhagic Infarction
Sponsor
Manuel Sanchez Luna (Other)
Overall Status
Recruiting
CT.gov ID
NCT05918016
Collaborator
(none)
360
1
105
3.4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
360 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Ultrasonographic Prognostic Scale of Periventricular Hemorrhagic Infarction in Preterm Infants With Gestational Age <30 Weeks
Actual Study Start Date
:
Jan 1, 2017
Anticipated Primary Completion Date
:
Jul 31, 2023
Anticipated Study Completion Date
:
Oct 1, 2025
Outcome Measures
Primary Outcome Measures
- Periventricular Hemorrhagic Infarction [first month]
Yes or no
- Characteristic Sonographic [first month]
- Neurodevelopmental outcome at age 2 years [first month]
Secondary Outcome Measures
- Medical records [first month]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Gestacional Age < 30 weeks
Exclusion Criteria:
-
Brain malformation
-
Genetic syndrome
-
Metabolic disorders
-
Chromosomal abnormality
-
None cranial ultrasound
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gregorio Marañon Hospital | Madrid | Spain | 28007 |
Sponsors and Collaborators
- Manuel Sanchez Luna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Manuel Sanchez Luna,
Doctor,
Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:
NCT05918016
Other Study ID Numbers:
- Neuro.Neo.1.IVH
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: