Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05262088 |
| Other study ID # |
10.04.12.2020 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
June 1, 2025 |
Study information
| Verified date |
April 2022 |
| Source |
West Kazakhstan Medical University |
| Contact |
Zhanna Zhussupova |
| Phone |
+77017910795 |
| Email |
tleuzhanna[@]mail.ru |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To study of the evolution of general movements in children, to develop criteria for early
diagnosis of neurological disorders to reduce early neurological disability.
It is observational longitudinal analytical cohort study.
Description:
According to hypothesis, assessment of general movements is an early diagnostic tool for
neurological disorders in children.
Combined estimates of epidemiological studies of neurological diseases in children under 3-5
years of age show that from 5.7% to 9.2% of children may have neurological disorders in
different areas of development. According to the statistical report, the birth rate in the
Aktobe region for 2019 and 2020 varies from 18.7 to 21.3 per 1000, that is, the expected
birth rate in the Regional Perinatal Center of 7000-7500 newborns in 2021. The number of
children in the region is 77360. Adjusted for an alpha error of 5% and a beta threshold of
20% (80% power), to achieve a predictive power of 0.95 and in accordance with selection
criteria, expected 155 children with neurological disorders. Taking into account the
cumulative frequency of disorders of neurological development of 9.2% in the study group, the
sample should include 1800 children.
The present observational study is conducted in a population cohort of children of the Aktobe
region. The motor repertoire of children aged 0 to 5 months will be evaluate and its
relationship with demographic, prenatal, perinatal factors and the outcome of neurological
development in the second year of life. The study (evaluation of general movements) is
carried out by 3 specialists: the first specialist (the main researcher is a doctoral
student) has access to all the survey materials, evaluates general movements from video
materials, has an initial level of knowledge on the evaluation of general movements; 2 the
specialist has a basic level (project manager) - has access to video recordings, has limited
access to evaluate other variables; 3 the specialist has an expert level of knowledge
(supervisor on a voluntary basis) on the evaluation of general movements, has access only to
video recordings. As part of the pilot approach, all three specialists will evaluate the
video recording of the movements of 50 infants, in the future it is planned to determine the
reliability among evaluators using the Cohen's Kappa coefficient. Reliability will be
considering high, when a coefficient of 0.61- 0.80 is reached.
The researcher on the 3rd-5th day of the child's life (home, hospital) explains in detail to
parents the project being implemented. After receiving the informed consent of the parents,
the researcher records the child's movements on video in accordance with the requirements,
while simultaneously teaching the child's mother.
At the first stage, all full-term newborns will be examined. The examination is carried out
no earlier than 3 days (adaptation period) after birth. At this stage, the child's general
condition and neurological status will be assessed. Clinical data include the status of
breastfeeding and the health status of the baby from the moment of birth. The Apgar scale
will be used to assess the general condition of the newborn. In the presence of perinatal
asphyxia, indicators on the Sarnat scale for neonatal encephalopathy will be used. Neonatal
encephalopathy, acute encephalopathy and/or hypoxic-ischemic encephalopathy will be evaluated
according to clinical and laboratory criteria. The following data will be evaluated: the sex
of the baby, the age of the baby in days, a family member with a disability, the gestational
age of the child at birth, birth weight, head circumference, the nutritional status of the
baby (breast, artificial, mixed). These variables, except for the latter, are continuous
(quantitative) indicators, all other data will be categorical. The weight and circumference
of the child's head will be considered a pathology if the deviation is more than 2 standard
deviations (SD) below the median (according to WHO). All data is entered into a specially
designed individual registration card.
At the next stage, general movements are evaluated in the following age periods: 3-5 days,
4-5, 8-9, 12-13, 16-17, 20-22 weeks of life. The division into stages of assessment is
fundamental, in the period from birth to 8-9 weeks, general movements are evaluated, which
are classified as normal, abnormal or cramped synchronized. Normal general movements include
an oscillating sequence of movements of the arms, neck, torso and legs. They increase and
decrease with changes in intensity, speed and range of motion. Their beginning and end are
usually gradual and smooth. The change of direction and rotation along the axes of the trunk
and limbs is smooth and elegant. Abnormal movements will be the following movements: "poor
repertoire" - the sequence of movements, their intensity, speed and range of movements are
not changeable; "cramped synchronized" - the muscles of the trunk and limbs seem stiff and
contract almost simultaneously, and then relax almost simultaneously.
The researcher on the 3rd-5th day of the child's life (home, hospital) explains in detail to
parents the project being implemented. After receiving the informed consent of the parents,
the researcher records the child's movements on video in accordance with the requirements,
while simultaneously teaching the child's mother.
At the first stage, all full-term newborns will be examined. The examination is carried out
no earlier than 3 days (adaptation period) after birth. At this stage, the child's general
condition and neurological status will be assessed. Clinical data include the status of
breastfeeding and the health status of the baby from the moment of birth. The Apgar scale
will be used to assess the general condition of the newborn. In the presence of perinatal
asphyxia, Sarnat scale for neonatal encephalopathy will be used. Neonatal encephalopathy,
acute encephalopathy and/or hypoxic-ischemic encephalopathy will be evaluated according to
clinical and laboratory criteria. The following data will be evaluated: the sex of the baby,
the age of the baby in days, a family member with a disability, the gestational age of the
child at birth, birth weight, head circumference, the nutritional status of the baby (breast,
artificial, mixed). These variables, except for the latter, are continuous (quantitative)
indicators, all other data will be categorical. The weight and circumference of the child's
head will be considered a pathology if the deviation is more than 2 SD (standard deviations)
below the median (according to WHO). All data is entered into a specially designed individual
registration card.
At the next stage, general movements are evaluated in the following age periods: 3-5 days,
4-5, 8-9, 12-13, 16-17, 20-22 weeks of life. The division into stages of assessment is
fundamental, in the period from birth to 8-9 weeks, general movements are evaluated, which
are classified as normal, abnormal or cramped synchronized. Normal general movements include
an oscillating sequence of movements of the arms, neck, torso and legs. They increase and
decrease with changes in intensity, speed and range of motion. Their beginning and end are
usually gradual and smooth. The change of direction and rotation along the axes of the trunk
and limbs is smooth and elegant. Abnormal movements will be the following movements: "poor
repertoire" - the sequence of movements, their intensity, speed and range of movements are
not changeable; "cramped synchronized" - the muscles of the trunk and limbs seem stiff and
contract almost simultaneously, and then relax almost simultaneously.
The obtained data will be entered into a special scheme with the subsequent construction of
the trajectory of changes for the analysis of the evolution of general movements.
General movements will be recorded on a 5-minute video. The video is shot from above the baby
(with the capture of the whole body of the child) lying on his back, in the conditions of the
maximum absence of sensory and tactile stimulation. At the same time, the child should be
awake, not hungry and lightly dressed. The videography technique is not complicated, does not
have strict training criteria, can be carried out by parents, medical staff.
In the catamnestic observation of children, the neurological status at the age of 1, 2, 5,
12, 18 and 24 months of life will bee assess. Neurological status is assessed according to
the Hammersmith Infant Neurological Examination (HINE) scale. This method is easy to use and
was developed for the examination of children aged 2 to 24 months. It includes 26 items that
evaluate the function of cranial nerves, posture, quality and quantity of movements, muscle
tone, reflexes and reactions. Each item is rated from 0 (minimum) to 3 (maximum score), which
gives a total score from 0 to 78. Sensitivity and specificity are about 0.90. According to
this scale, the child's posture and posture are evaluated.
According to the results of the neurological examination, 2 groups will be identified:
healthy and neurological disorders, which may include motor disorders associated with
cerebral palsy, motor disorders not associated with cerebral palsy, epilepsy, orthopedic
congenital malformations, muscular dystrophy, spinal muscular atrophy, developmental delay,
genetic disorders, visual impairment, hearing impairment or a high risk of mental disorders.
Children with manifestations of abnormal movements, up to 5 months of age, all will undergo
neurosonography (NSG - ultrasound of the brain).
Verification of the clinical diagnosis will be carry out according to the diagnostic criteria
of the current clinical protocols of the Ministry of Health of the Republic of Kazakhstan and
international classifications. In addition, all data will be entering into special designed
individual registration card (IRC).
