Clinical trial NCT05217056: Associations Between General Movements Assessments and Cognitive Development
Official title: Associations Between General Movements Assessments and Cognitive Development in a Cohort of High Risk of Infants: One Year Follow Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Infant Development
Cognitive Dysfunction
Cognitive Developmental Delay
Cognitive Impairment, Mild
Infant, Small for Gestational Age
Infant, Premature, Diseases
Infant Asphyxia
Infant, Very Low Birth Weight
Keywords: General Movements(GMs)
Cognitive Development
BAYLEY-III Infant and Toddler Development Assessment
High Risk of Infants
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 63
Sex: ALL
Minimum age (years): 25
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: high risk of infanst for cerebral palsy

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Having periventricular hemorrhage, ICH stages 2, 3, 4, cystic PVL, stage 3 HIE, kernicterus, perinatal asphyxia, chronic lung disease, RDS, BPD, long-term oxygen (7 days), \>24 hours mechanical ventilator (MV) support, 5th minute Apgar Score \<3, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), gestation age \<32 weeks, and prematurity due to preterm/multiple births\<1500 gr.

Exclusion Criteria:

* Infants with congenital malformation (Spina Bifida, Congenital Muscular Torticollis, Arthrogriposis Multiplex Congenita etc.)
* Infants diagnosed with metabolic and genetic diseases (Down Syndrome,Spinal Muscular Atrophy, Duchenne Muscular Dystrophy etc.)
* Infants still intubated and mechanical ventilator dependent at postterm 3 months

Primary outcomes:
measure: Prechtl's General movements (GMs) assessments1
timeFrame: Measurement at preterm age (birth to 40weeks)
measure: Prechtl's General movements (GMs) assessments2
timeFrame: Measurement between the term age to 9th weeks
measure: Prechtl's General movements (GMs) assessments3
timeFrame: Measurement at fidgety periods of life (between 10th weeks to 20th weeks)
measure: The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
timeFrame: Change from the baseline of the BAYLEY-III score at 3, 6,12th month of infants
Secondary outcomes:
measure: demographic information1
timeFrame: first day of birth
measure: demographic information2
timeFrame: first day of birth
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Hatice Adıgüzel
state: Dulkadiroglu
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: hatice adıgüzel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Bulent Elbasan, Proffessor
role: STUDY_DIRECTOR
References: