NCT05262088

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

2.2 years

First QC Date

February 16, 2022

Last Update Submit

April 25, 2022

Conditions

Cerebral PalsyChild Behavior DisordersNeurologic DisorderPediatric Disorder

Outcome Measures

Primary Outcomes (1)

  • Changing the frequency of disability of children with neurological disorders

    Early diagnosis of neurological disorders, and early rehabilitation interventions

    2 years

Study Arms (1)

newborns

Assessment of the motor repertoire in children aged 0 to 5 months and its relationship with prenatal and perinatal factors and the results of neurological development in the second year of life.

Other: video recording of general movements

Interventions

video recording of general movementsOTHER

Video recording of general movements of children aged 3-5 days, then 4-5, 8-9, 12-13, 16-17, 20-22 weeks of life. At the age of 12 weeks of life, an assessment will be made on the Motor Optimality Scale (MOS).

newborns

Eligibility Criteria

Age1 Day - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The present observational study is conducted in a population cohort of children aged 0 to 5 months of life. The motor repertoire of children aged 0 to 5 months will be evaluate, and its relationship with demographic, prenatal, perinatal factors and the results of neurological development in the second year of life. Newborn boys and girls are included in the study with the informed consent of their parents.

You may qualify if:

  • all full-term newborn children born in the city of Aktobe in the period from
  • both male and female children
  • patients whose parents have signed an informed consent to data collection
  • patients, as long as parents are able to comply with the requirements of the study protocol.

You may not qualify if:

  • premature babies
  • children with suspected chromosomal and metabolic diseases
  • children of parents who have not signed the informed consent.
  • children with fatal outcome are excluded in dynamics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhanna Zhussupova

Aktobe, 040017, Kazakhstan

RECRUITING

Related Publications (2)

  • Einspieler C, Bos AF, Krieber-Tomantschger M, Alvarado E, Barbosa VM, Bertoncelli N, Burger M, Chorna O, Del Secco S, DeRegnier RA, Huning B, Ko J, Lucaccioni L, Maeda T, Marchi V, Martin E, Morgan C, Mutlu A, Nogolova A, Pansy J, Peyton C, Pokorny FB, Prinsloo LR, Ricci E, Saini L, Scheuchenegger A, Silva CRD, Soloveichick M, Spittle AJ, Toldo M, Utsch F, van Zyl J, Vinals C, Wang J, Yang H, Yardimci-Lokmanoglu BN, Cioni G, Ferrari F, Guzzetta A, Marschik PB. Cerebral Palsy: Early Markers of Clinical Phenotype and Functional Outcome. J Clin Med. 2019 Oct 4;8(10):1616. doi: 10.3390/jcm8101616.

    PMID: 31590221RESULT

  • Toldo M, Varishthananda S, Einspieler C, Tripathi N, Singh A, Verma SK, Vishwakarma K, Zhang D, Dwivedi A, Gupta R, Karn S, Kerketta N, Narayan R, Nikam Singh K, Rani S, Singh A, Singh D, Singh KP, Singh N, Singh N, Singh R, Singh SP, Srivastava R, Srivastava S, Srivastava S, Yadav G, Yadav P, Yadav S, Yadav S, Marschik PB. Enhancing early detection of neurological and developmental disorders and provision of intervention in low-resource settings in Uttar Pradesh, India: study protocol of the G.A.N.E.S.H. programme. BMJ Open. 2020 Nov 3;10(11):e037335. doi: 10.1136/bmjopen-2020-037335.

    PMID: 33148727RESULT

MeSH Terms

Conditions

Cerebral PalsyChild Behavior DisordersNervous System Diseases

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Dinmuhammed Ayaganov

    West Kazakhstan Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhanna Zhussupova

CONTACT

+77017910795tleuzhanna@mail.ru

Myltykbay Rysmakhanov

CONTACT

+77017407189mrhirurg1977@mail.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-doctoral, Department of Neurology

Study Record Dates

First Submitted

February 16, 2022

First Posted

March 2, 2022

Study Start

January 1, 2021

Primary Completion

March 1, 2023

Study Completion

June 1, 2025

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

KA(1)