An observational study in Cerebral Palsy, Infant Development and Cognitive Dysfunction, sponsored by Kahramanmaras Sutcu Imam University. Completed at 1 site in Turkey. Open to participants aged 25 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2022-02-01.
Sponsored by Kahramanmaras Sutcu Imam University · Observational
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Among 14 studies in Cerebral Palsy by Kahramanmaras Sutcu Imam University — none open to participants now, none under way, none of them phase 3. Cerebral Palsy · Kahramanmaras Sutcu Imam University.
Among the 14 studies in Cerebral Palsy by Kahramanmaras Sutcu Imam University, this one is the 8th largest by enrollment of the 11 observational ones that give a count, is one of 2 that started in 2020, is one of 11 observational ones, and was the 3rd registered.
1,937 studies on the registry are indexed under Cerebral Palsy; 457 are open to participants now.
Browse Cerebral Palsy studies →None of the 14 studies in Cerebral Palsy by Kahramanmaras Sutcu Imam University is open now. The open studies under Cerebral Palsy, anywhere →
Of the 269 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 234 (87%) stop at 75 or younger; 254 take children under 18; 51 take healthy volunteers.
This study: 25 Weeks to 42 Weeks · all sexes · no healthy volunteers.
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14 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 2 started in 2020.
This study's enrollment of 63 is close to the median of 63 across 473 observational studies indexed under Cerebral Palsy.
Median enrollment 22 across the 3 interventional studies, 91 across the 11 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
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Kahramanmaras Sutcu Imam University is the lead sponsor of 199 studies on the registry; 41 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Cerebral Palsy by Kahramanmaras Sutcu Imam University, from their registry updates:
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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.
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.
high risk of infanst for cerebral palsy
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Exclusion Criteria:
All of the infants with high risk of cerebral palsy
Other: measurements
All 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.
Prechtl's General movements (GMs) assessments1
General movements (GMs) are the spontaneous movement repertoire present from early foetal life until 20 weeks post-term. From birth to 8 post-term weeks, they have a "writhing" character. They will be scored as cs-pr-n-ch. N show normal movement patterns.
Time frame: Measurement at preterm age (birth to 40weeks)
Prechtl's General movements (GMs) assessments2
General movements (GMs) are the spontaneous movement repertoire present from early foetal life until 20 weeks post-term. From birth to 8 post-term weeks, they have a "writhing" character. They will be scored as cs-pr-n-ch. N show normal movement patterns.
Time frame: Measurement between the term age to 9th weeks
Prechtl's General movements (GMs) assessments3
General movements (GMs) are the spontaneous movement repertoire present from early foetal life until 20 weeks post-term. From birth to 8 post-term weeks, they have a "writhing" character and then till about 20 weeks a "fidgety" character. Two specific abnormal movement patterns reliably predict CP in fidgety term: F (-): the absence of the fidgety character from 8-20 post-term weeks. Fidgety movements (FMs) are classified as (a) normal (F+), (b) absent (AF), when normal FMs are never observed and (c) abnormal (F-).
Time frame: Measurement at fidgety periods of life (between 10th weeks to 20th weeks)
The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
The BSID-III is a neurocognitive assessment used to evaluate infants from 0-42 months and to monitor their development with 5 domains: cognitive, language (receptive and expressive communication), motor (fine and gross motor), social-emotional, and adaptive functions (17). The first three domains will be assessed. To allow comparison of results from the 5 domains, a composite score will be calculated for each domain (mean, 100±15). A composite score below -2 standard deviation (SD) (\<70) will be considered a severe delay for all domains.
Time frame: Change from the baseline of the BAYLEY-III score at 3, 6,12th month of infants
demographic information1
birth age of the infants will be recorded in weeks
Time frame: first day of birth
demographic information2
birth weight of the infants will be recorded in kilograms
Time frame: first day of birth
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2020 to primary completion in Aug 2021, 12 months.
Of 215 non-industry observational studies under Cerebral Palsy, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 60. This study's 12 months is below that.
Counting every sponsor, half of 219 studies reached it within 21 months; a quarter within 8 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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