NCT05778357

Brief Summary

Development; It covers the areas of physical, mental, emotional and social development. Development in one area affects other areas as well. Infancy is the period in which children grow and develop the fastest. Babies need many environmental factors and stimulants in order to have a healthy developmental process. For the Covid 19 pandemic, many restrictions have been made in Turkey to reduce the spread of the epidemic and to maintain social distance between people. It has been suggested that individuals practice their own social isolation. It has also caused babies who spend their time at home during the pandemic process to be deprived of environmental stimuli. In current studies in the literature, it has been reported that the COVID-19 pandemic affects infant and child development significantly and negatively. It has been reported that the risk of delay in children who have experienced the COVID-19 pandemic is especially in the fine motor and communication areas. There is a limited number of studies in the literature on this subject. No study was found in Turkey. The aim of this study is to evaluate the neuromotor development of infants in early childhood (6-24 months) in the Covid-19 pandemic and to reveal the effects of the pandemic process. Denver II Developmental Screening Test was used to evaluate the neuromotor development of healthy infants aged 6-24 months, who applied to the healthy pediatric outpatient clinic of Acıbadem Altunizade Hospital, and Alberta Infant Motor Scale was used to evaluate gross motor functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

March 19, 2023

Last Update Submit

March 19, 2023

Conditions

Keywords

alberta infant motor scaledenver II developmental screening testcovid-19 pandemicpediatric rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Denver II Developmental Screening Test

    It is a screening test used in children aged 0-6 years. The test is done in a short time like 5-15 minutes. The person who will administer the Denver II test; must be trained and certified. Standardized test materials are used. The test consists of 4 sections and 134 items. There are personal-social, language, fine motor and gross motor sections. The test result is classified as Normal - Abnormal - Suspicious.

    baseline

  • Alberta infant motor scale

    It is used to observe gross motor functions and evaluate the effectiveness of the intervention in typically developing infants between 0-18 months. The duration of the test is 10 minutes and consists of 58 items. The child's spontaneous movements are evaluated in 4 different positions without touching the child. 1 point is taken for each item that can be done. A table containing the mean and standard deviation for each month is used. The test result is classified as Normal - Abnormal - Suspicious.

    baseline

Study Arms (1)

Evaluation of neuromotor development of healthy infants

75 healthy infants were included. Neuromotor development was evaluated with the Denver II Developmental Screening Test and Alberta Infant motor scale.

Other: Group1

Interventions

Group1OTHER

75 healthy infants were included. Neuromotor development was evaluated with the Denver II Developmental Screening Test and Alberta Infant motor scale.

Evaluation of neuromotor development of healthy infants

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

75 healthy infants aged 6-24 months were included.

You may qualify if:

  • healthy infants aged 6-24 months were included.

You may not qualify if:

  • Having a physical/mental/neuromotor/psychological problem
  • Not between 6-24 months in the pandemic process
  • Presence of a diagnosed disease
  • Having a vision problem
  • Having a hearing problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Learning DisabilitiesCOVID-19

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nilay Arman

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Physiotherapist

Study Record Dates

First Submitted

March 19, 2023

First Posted

March 21, 2023

Study Start

June 25, 2022

Primary Completion

October 25, 2022

Study Completion

October 25, 2022

Last Updated

March 21, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers.

Locations