NCT05918016

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

6.6 years

First QC Date

June 7, 2023

Last Update Submit

June 15, 2023

Conditions

PretermsInfarction Cerebral

Outcome Measures

Primary Outcomes (3)

  • Periventricular Hemorrhagic Infarction

    Yes or no

    first month

  • Characteristic Sonographic

    first month

  • Neurodevelopmental outcome at age 2 years

    first month

Secondary Outcomes (1)

  • Medical records

    first month

Interventions

Routine cranial ultrasoundsDIAGNOSTIC_TEST

we will use the routine cranial ultrasounds

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newborn with gestational age \< 30 weeks

You may qualify if:

  • Gestacional Age \< 30 weeks

You may not qualify if:

  • Brain malformation
  • Genetic syndrome
  • Metabolic disorders
  • Chromosomal abnormality
  • None cranial ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gregorio Marañon Hospital

Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Manuel Sánchez Luna, Doctor

CONTACT

msluna@salud.madrid.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 26, 2023

Study Start

January 1, 2017

Primary Completion

July 31, 2023

Study Completion

October 1, 2025

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)