GMA and Peri in Moderate-late Preterms

August 27, 2019 updated by: University of Castilla-La Mancha

Early Detection of the Cerebral Palsy in Moderate and Late Preterms Through the General Movements

To analyze the relationship between the early diagnosis of cerebral palsy with the risk factors of this pathology in moderate and late premature infants

Study Overview

Status

Unknown

Conditions

Detailed Description

Analyze a sample of moderate and late premature infants using general movements and verify which of them would have an early diagnosis of cerebral palsy and relate it to their risk factors for this pathology.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Locations

  • Spain
      • Toledo, Spain, 45006
        • Recruiting
        • Javier Merino Andrés
        • Contact:

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

7 months to 8 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects who were born between the week 32 + 0 days and the week 36 + 6 days

Description

Inclusion Criteria:

  • Subjects who were born between the week 32 + 0 days and the week 36 + 6 days and who are admitted to the Hospital Nuestra Señora del Prado de Talavera de la Reina or the Hospital Virgen de la Salud de Toledo.

Exclusion Criteria:

  • Any type of pre and perinatal diagnostic neurological involvement.
  • Any type of pathology associated with prematurity.

  • Children who have prescribed any of the following medications (10):

    • Barbiturates
    • Antiepileptic
    • Indomethacin
    • Dexamethasone

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
gestation weeks
Time Frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
Premature birth week
From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
weight
Time Frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
measurement, World Health Organization percentile
From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
size
Time Frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
measurement, World Health Organization percentile
From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
cranial perimeter
Time Frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
measurement about head, World Health Organization percentile
From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
Apgar
Time Frame: at birth of each preterm
Outcome about Apgar Test
at birth of each preterm
Magnetic resonance imaging rating scale
Time Frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
Outcome about Neuroimaging in preterms
From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
general movements outcome
Time Frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
Outcome about General Movements Assessment. Three outcomes about movement of preterm. Normal, Poor Repertoire and Cramped Synchronized
From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
PERI outcome
Time Frame: through study completion, an average of 18 months
Outcome about Perinatal Risk Scale Scale. Minimum score: 0. Maximum score: 51
through study completion, an average of 18 months

Collaborators and Investigators

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

Sponsor

University of Castilla-La Mancha

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, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Actual)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • jma001

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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