GMA and Peri in Moderate-late Preterms

• Conditions: Risk Factor; Preterm; Assessment; Cerebral Palsy

• Registration Number: NCT04073836
• Lead Sponsor: University of Castilla-La Mancha

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.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-27
• Last Update Submitted: 2019-08-27
• Study First Posted: 2019-08-29
• Last Update Posted: 2019-08-29
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apgar	at birth of each preterm	Outcome about Apgar Test
gestation weeks	From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks	Premature birth week
size	From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks	measurement, World Health Organization percentile
weight	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	From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks	Outcome about Neuroimaging in preterms
cranial perimeter	From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks	measurement about head, World Health Organization percentile
general movements outcome	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	through study completion, an average of 18 months	Outcome about Perinatal Risk Scale Scale. Minimum score: 0. Maximum score: 51

Trial Locations

Locations (1)

Javier Merino Andrés; 🇪🇸 Toledo, Spain