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Clinical Trials/NCT04073836
NCT04073836
Unknown
N/A

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

University of Castilla-La Mancha1 site in 1 country150 target enrollmentJanuary 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preterm
Sponsor
University of Castilla-La Mancha
Enrollment
150
Locations
1
Primary Endpoint
gestation weeks
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 31, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Castilla-La Mancha
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

gestation weeks

Time Frame: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

Premature birth week

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

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

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

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

Apgar

Time Frame: at birth of each preterm

Outcome about Apgar Test

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

PERI outcome

Time Frame: through study completion, an average of 18 months

Outcome about Perinatal Risk Scale Scale. Minimum score: 0. Maximum score: 51

Study Sites (1)

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