Clinical Trials Directory

Trials / Completed

CompletedNCT05217056

Associations Between General Movements Assessments and Cognitive Development

Associations Between General Movements Assessments and Cognitive Development in a Cohort of High Risk of Infants: One Year Follow Up

Status
Completed
Phase
Study type
Observational
Enrollment
63 (actual)
Sponsor
Kahramanmaras Sutcu Imam University · Academic / Other
Sex
All
Age
25 Weeks – 42 Weeks
Healthy volunteers
Not accepted

Summary

High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems. It is a heterogeneous group of premature infants born under thirty-seven weeks of age, with infants with low birth weight, term or developmental retardation for various reasons. Therefore, preterm infants with low birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy, hearing and vision loss, mental retardation, speech and speech problems, and learning difficulties. The clinical diagnosis of CP and learning diffuculties which can be observed in high-risk infants, is based on the combination of some neurological and clinical signs.

Detailed description

High-risk of infant follow-up programs provide guidance for the treatment of neurodevelopmental delays and deterioration in terms of early development. Three methods with the best predictable validity that can determine CP before the adjusted age of 5-month is Magnetic Resonance Imaging (MRI), Prechtl's Assessment of General Movements (GMs), Hammersmith Infant Neurological Evaluation. In recent years, the diagnosis of high-risk of CP can be detected at 3 months with predictive validity and reliability by evaluating the quality of GMs. GMs are now considered the gold standard for early detection of CP because of its high sensitivity and specificity than MRI, cranial US and neurological evaluations. It was also found that cognitive or language skills may be inadequate in school age in patients with inadequate movement character and in the same postural patterns according to age, although GMs are normal. So new clinical care guidelines and new intervention research for infants with CP and learning diffuculties under the age of 1, needs to be been shown. There a few studies about early detection of learning diffuculties like autism spectrum disorders between GMs and cognitive development tests. So this study aimed to reveal the association between GMs and cogtinive development with a cohort of high risk of infants with one year floow up.

Conditions

Interventions

TypeNameDescription
OTHERmeasurementsAll of the infants with high risk of cerebral palsy will be assessed from birth to 12 months age with the assessments of Prechtl's General movements (GMs) until 20 weeks of age. Also BAYLEY-III Infant and Toddler Development Assessment Scale (BAYLEY-III) will be performed at the 3rd, 6th, and 12th months for the cognitive development.

Timeline

Start date
2020-08-01
Primary completion
2021-08-30
Completion
2021-09-30
First posted
2022-02-01
Last updated
2022-02-01

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05217056. Inclusion in this directory is not an endorsement.