- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05778357
The Effect of the Covid 19 Pandemic Process on the Neuromotor Developments of 6-24 Month-old Babies
March 19, 2023 updated by: Gökçen Erol, Istanbul University - Cerrahpasa (IUC)
The Effect of the Covid 19 Pandemic Process on the Neuromotor Developments of 6-24 Month-old Babies: A Cross-sectional Study From Turkey
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It is an observational study. Purpose of the study: evaluating the neuromotor development of infants in early childhood (6-24 months) in the Covid-19 pandemic and revealing the effects of the pandemic process.
75 healthy infants aged 6-24 months were included.
- Will there be developmental delays in children born in the Covid 19 pandemic?
- In which parameter delay is observed the most.
Denver II Developmental Screenin Test and Alberta Infant Motor Scale were applied to the participants.
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Acıbadem Altunizade Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 2 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
75 healthy infants aged 6-24 months were included.
Description
Inclusion Criteria:
- 75 healthy infants aged 6-24 months were included.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
75 healthy infants were included.
Neuromotor development was evaluated with the Denver II Developmental Screening Test and Alberta Infant motor scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Denver II Developmental Screening Test
Time Frame: baseline
|
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
Time Frame: baseline
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Nilay Arman, Istanbul University - Cerrahpasa (IUC)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2022
Primary Completion (Actual)
October 25, 2022
Study Completion (Actual)
October 25, 2022
Study Registration Dates
First Submitted
March 19, 2023
First Submitted That Met QC Criteria
March 19, 2023
First Posted (Actual)
March 21, 2023
Study Record Updates
Last Update Posted (Actual)
March 21, 2023
Last Update Submitted That Met QC Criteria
March 19, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GErol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be made available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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