Development, InfantNCT05778357
The Effect of the Covid 19 Pandemic Process on the Neuromotor Developments of 6-24 Month-old Babies
An observational study of Development, Infant and Development Delay, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Development, Infant, Development Delay
- What is being tested?
- Group1
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2022to 25 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 75 healthy infants aged 6-24 months were included.
Who may be able to join
- 75 healthy infants aged 6-24 months were included.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Development, Infant, Development Delay
- Being tested
- Group1
- Keywords
- alberta infant motor scale, denver II developmental screening test, covid-19 pandemic, pediatric rehabilitation
- Medical subject headings
- Learning Disabilities, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group1Other
75 healthy infants were included. Neuromotor development was evaluated with the Denver II Developmental Screening Test and Alberta Infant motor scale.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Group1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start25 Jun 2022
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development, InfantStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökçen Erol, Istanbul University - Cerrahpasa
- Investigators
- Nilay Arman, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778357
- Sponsor's protocol ID
- GErol
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Covid 19 Pandemic Process on the Neuromotor Developments of 6-24 Month-old Babies: A Cross-sectional Study From Turkey
- ClinicalTrials.gov ID
- NCT05778357
- Acronym / sponsor ID
- GErol
- Conditions
- Development, Infant, Development Delay
- Keywords
- alberta infant motor scale, denver II developmental screening test, covid-19 pandemic, pediatric rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of neuromotor development of healthy infants | – | Other: Group175 healthy infants were included. Neuromotor development was evaluated with the Denver II Developmental Screening Test and Alberta Infant motor scale. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 75 healthy infants aged 6-24 months were included.
Key inclusion criteria (1 listed)
- 75 healthy infants aged 6-24 months were included.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group175 healthy infants were included. Neuromotor development was evaluated with the Denver II Developmental Screening Test and Alberta Infant motor scale. | Other | Evaluation of neuromotor development of healthy infants |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
Related trials for Development, Infant
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
Tiny Tummies - A Milk Study
Gut Microbiome, Neurocognitive Correlates of Eating Habits
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilay Arman study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development, Infant and Development Delay, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Denver II Developmental Screening Test (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.