Associations Between General Movements Assessments and Cognitive Development

NCT05217056 | Completed

• 1 other identifier: KSU2
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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-).

  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.

  Change from the baseline of the BAYLEY-III score at 3, 6,12th month of infants

Secondary Outcomes (2)

• demographic information1

  first day of birth

• demographic information2

  first day of birth

Study Arms (1)

1/Measurement

All of the infants with high risk of cerebral palsy

Other: measurements

Interventions

measurements OTHER

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.

1/Measurement

Eligibility Criteria

• Age: 25 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

high risk of infanst for cerebral palsy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Hatice Adıgüzel

Kahramanmaraş, Dulkadiroglu, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Cognitive Dysfunction; Infant, Premature, Diseases

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• hatice adıgüzel, PhD

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

• Bulent Elbasan, Proffessor

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 1, 2022
• Study Start: August 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)