Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements

NCT05217186 | Completed

• 1 other identifier: KSU1
• 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, which can be observed in high-risk infants, is based on the combination of some neuroimaging and neurological examinations and assesments like neonatal imaging, general movements (GMs) and Hammersmith Infant Neurological Examination (HINE).

Conditions

Cerebral Palsy; Infant, Premature, Diseases; Infant Development; Neurologic Disorder; Development Delay; Infant Asphyxia; Infant, Small for Gestational Age; Infant, Newborn, Disease; Infant, Very Low Birth Weight

Keywords

Neonatal Neuroimaging; Hammersmith Infant Neurological Evaluation (HINE); General Movements (GMs); High Risk of Infants

Outcome Measures

Primary Outcomes (7)

• Neonatal Magnetic Resonance Imaging (MRI)

  Classification will be made according to the myelination status of the posterior internal capsule (PLIC), which is a robust marker showing the integrity of the cortical-spinal cord pathways at term. 1. CP development is unlikely. Minor anomalies not associated with normal imaging or development of CP, such as IVH grade 1-2. PLIC is in normal view. 2. Uncertain, SP possible but unlikely. Images show some evidence of damage, but symmetrical myelination is present in PLICs. Examples are stage 3 IVH, stroke not affecting the motor pathway, or HIE followed by lesion without basal ganglia or thalamus (BGT), hypoxic-ischemic injury without PLIC, pyramids, or perirolandic area 3. He is very likely to develop CP. Evidence of brain damage or malformations involving abnormal motor structures/absence of myelination in PLICs. Typical examples; stage IV IVH, cystic PVL, HIE with IGT involvement, or brain malformation with motor cortex involvement and any imaging abnormal and with PLIC

  at term age of infants (40 weeks), one assesment

• Hammersmith Neonatal Neurological Examination (HNNE)

  HNNE Developed by Dubowitz and used for clinical and research purposes in the neurological examination of infants. The current form of the examination; Optimality scores were standardized by evaluating low-risk term and high-risk preterm infants at term age, 6-48 hours after birth. This scale consists of a standard proforma consisting of 34 items. Items in the proforma are scored between 1-3. Half points can be given to an item. High scores indicate good neurological status. This proforma; It is divided into 6 categories: tone (10), tone patterns (5), reflexes (6), movements (3), abnormal signs (3), and behavior (7).

  at term age of infants (40 weeks), one assesment

• Hammersmith Infant Neurological Examination (HINE)

  The HINE is a simple, standardized, and scorable test for the clinical neurological evaluation of 2-to-24-month-old infants. It has 3 sections: (1) neurological examination (26 items, scored) evaluating cranial nerve function, posture, movements, tone, reflexes, and reactions, (2) motor milestones (8 items, unscored), and (3) behaviour (3 items, unscored). Each of the 26 items is scored first separately (as 0, 1, 2, or 3, half scores) and then the total score is calculated with a maximum score of 78. Higher score indicates good neurological function.

  Change from the baseline of the HINE score at 2, 3, 6, 9,12th month of infants

• 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

• General Movement Assessment (GMs)1

  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)

• General Movement Assessment (GMs)2

  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

• General Movement Assessment (GMs)3

  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)

Secondary Outcomes (2)

• demographic information1

  first day of birth

• demographic information2

  first day of birth

Interventions

Measurements DIAGNOSTIC_TEST

All infants wirth high risk of cp will be assessed by neuroimaging and Hammersmith Neonatal Neurological Examination (HNNE) at term age, Prechtl's General movements (GMs) assessments form birth up to 3-5 months, and will be assesed by Hammersmith Infant Neurological Examination (HINE) at 2,3,6,9 and 12th months, also BAYLEY-III Infant and Toddler Development Assessment Scale (BAYLEY-III) at the 3rd, 6th, and 12th months.

Also known as: Measurements of neurological development.

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 infants for cerebral palsy.

You may qualify if:

• Have 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 Adiguzel

Kahramanmaraş, Dulkadiroglu, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Infant, Premature, Diseases; Nervous System Diseases; Learning Disabilities; Disease

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Pathologic Processes

Study Officials

• hatice adıgüzel, PhD

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• 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: September 15, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 15, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)