Ultrasonographic Prognostic Scale of Periventricular Hemorrhagic Infarction

June 15, 2023 updated by: Manuel Sanchez Luna

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newborn with gestational age < 30 weeks

Description

Inclusion Criteria:

  • Gestacional Age < 30 weeks

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periventricular Hemorrhagic Infarction
Time Frame: first month
Yes or no
first month
Characteristic Sonographic
Time Frame: first month
first month
Neurodevelopmental outcome at age 2 years
Time Frame: first month
first month

Secondary Outcome Measures

Outcome Measure
Time Frame
Medical records
Time Frame: first month
first month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manuel Sanchez Luna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Estimated)

July 31, 2023

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuro.Neo.1.IVH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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