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临床试验/NCT05217056
NCT05217056已完成不适用

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

Kahramanmaras Sutcu Imam University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Prechtl's General movements (GMs) assessments1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
25 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Prechtl's General movements (GMs) assessments1

时间窗: Measurement at preterm age (birth to 40weeks)

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.

Prechtl's General movements (GMs) assessments2

时间窗: Measurement between the term age to 9th weeks

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.

Prechtl's General movements (GMs) assessments3

时间窗: Measurement at fidgety periods of life (between 10th weeks to 20th weeks)

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-).

The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)

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

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.

次要结局

  • demographic information1(first day of birth)
  • demographic information2(first day of birth)

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatice Adiguzel

Assistant Proffessor

Kahramanmaras Sutcu Imam University

研究点 (1)

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