GMA and Peri in Moderate-late Preterms

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04073836
• Other study ID #: jma001
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2019
• Source: University of Castilla-La Mancha
• Contact: Javier Merino Andrés, MsC
• Phone: 925268800
• Email: Javier.Merino[@]uclm.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Weeks to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Assessment
• Cerebral Palsy
• Premature Birth
• Preterm
• Risk Factor

Locations

Country	Name	City	State
Spain	Javier Merino Andrés	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

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