GMA and Peri in Moderate-late Preterms
Early Detection of the Cerebral Palsy in Moderate and Late Preterms Through the General Movements
1 other identifier
observational
150
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 21, 2019
CompletedFirst Posted
Study publicly available on registry
August 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 29, 2019
August 1, 2019
3 years
August 21, 2019
August 27, 2019
Conditions
Outcome Measures
Primary Outcomes (8)
gestation weeks
Premature birth week
From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
weight
measurement, World Health Organization percentile
From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
size
measurement, World Health Organization percentile
From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks
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
Apgar
Outcome about Apgar Test
at birth of each preterm
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
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
PERI outcome
Outcome about Perinatal Risk Scale Scale. Minimum score: 0. Maximum score: 51
through study completion, an average of 18 months
Eligibility Criteria
Subjects who were born between the week 32 + 0 days and the week 36 + 6 days
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Javier Merino Andrés
Toledo, 45006, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2019
First Posted
August 29, 2019
Study Start
January 1, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
August 29, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share