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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05918016
Other study ID # Neuro.Neo.1.IVH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2017
Est. completion date October 1, 2025

Study information

Verified date June 2023
Source Hospital General Universitario Gregorio Marañon
Contact Manuel Sánchez Luna, Doctor
Email msluna@salud.madrid.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date October 1, 2025
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Gestacional Age < 30 weeks Exclusion Criteria: - Brain malformation - Genetic syndrome - Metabolic disorders - Chromosomal abnormality - None cranial ultrasound

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Routine cranial ultrasounds
we will use the routine cranial ultrasounds

Locations

Country Name City State
Spain Gregorio Marañon Hospital Madrid

Sponsors (1)

Lead Sponsor Collaborator
Manuel Sanchez Luna

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Periventricular Hemorrhagic Infarction Yes or no first month
Primary Characteristic Sonographic first month
Primary Neurodevelopmental outcome at age 2 years first month
Secondary Medical records first month
See also
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