Early Childhood DevelopmentNCT07418528
Understanding Early Development of Infants and Toddlers
An observational study of Early Childhood Development and Infant Development, run by Bartosz M. Radtke at 1 site in Poland.
Trial summary
The goal of this observational study is to analyze early development in infants and young children from a biopsychosocial perspective, with a particular focus on cognitive, language, motor, social-emotional, and adaptive functioning during the first years of life. Read more about this study
- Who is it for?
- Ages 16 days to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Development, Infant Development, Child Development
- What is being tested?
- Psychological developmental assessment
- How many people
- 1,200 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 days to 42 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants and young children aged 16 days to 42 months, including children with typical development and children with increased developmental risk.
Who may be able to join
- Infants and young children aged from 16 days to 42 months at the time of assessment.
- Participation of a parent or legal guardian able to provide informed consent.
- Child's ability to participate in a standardized developmental assessment appropriate for age and developmental level.
- Availability of basic medical and perinatal information provided by parents or caregivers.
- Assignment to one of the predefined study cohorts based on medical history and developmental status:
- children from the general population (control group), children with developmental delay, children with confirmed genetic conditions, children born preterm between 33 and 37 weeks of gestation, children born before 33 weeks of gestation, children with a diagnosis of cerebral palsy.
Who cannot join
- Severe acute medical condition at the time of assessment preventing participation in the psychological evaluation.
- Uncorrected severe sensory impairments (e.g., profound visual or hearing impairment) that preclude valid administration or interpretation of the developmental assessment.
- Medical instability or conditions requiring immediate intensive medical care.
- Lack of informed consent from a parent or legal guardian.
- Inability of the parent or caregiver to provide reliable information required for questionnaire-based assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Laboratory of Psychological and Educational Tests
Gdansk, Pomeranian Voivodeship, 80-239
Rafał Nowicki, M.A., +48509805591, nowicki@pracowniatestow.pl
About this study
Official title: Understanding Early Development: A Biopsychosocial Perspective on Infant and Toddler Functioning
The goal of this observational study is to analyze early development in infants and young children from a biopsychosocial perspective, with a particular focus on cognitive, language, motor, social-emotional, and adaptive functioning during the first years of life.
The study will include infants and young children from 16 days of age up to 42 months of age, assessed during a single diagnostic session conducted by qualified specialists. The developmental assessment will include standardized diagnostic tasks and direct observation of behavior in the form of play and natural interaction, carried out in the presence of a parent or legal guardian.
Read more
In addition, information regarding the child's everyday functioning will be collected from parents or caregivers using standardized questionnaires, including data on social-emotional competencies, communication, and adaptive skills.
The main research questions addressed by this study are:
What is the developmental profile of infants and young children in the first years of life?
What relationships exist between different domains of early development within a biopsychosocial model of child functioning?
Can specific developmental patterns be identified that indicate an increased risk of developmental difficulties in early childhood?
How does age differentiate the structure and variability of developmental functioning across assessed domains?
The study is non-invasive and observational in nature. Data will be analyzed exclusively in aggregated form and will contribute to a better understanding of early child development as well as to the development of norms and tools supporting early diagnosis and developmental intervention.
- Being tested
- Psychological developmental assessment
- Keywords
- Early development, Infant development, Toddler development, Neurodevelopment, Cognitive development, Language development, Motor development, Social-emotional development, Adaptive behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological developmental assessmentDiagnostic test
All participants undergo a standardized psychological developmental assessment conducted by trained specialists. The assessment includes structured diagnostic tasks and direct observation of the child's behavior during play and natural interaction, carried out in the presence of a parent or legal guardian. In addition, parents or caregivers complete standardized questionnaires assessing the child's social-emotional functioning and adaptive behavior. No experimental intervention or therapeutic procedure is applied.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Children without identified developmental delays, genetic conditions, or major perinatal complications, assessed as part of the general population. Receives: Diagnostic Test: Psychological developmental assessment | |
| Developmental Delay | Children with identified developmental delay based on prior clinical assessment or referral information, without a confirmed specific genetic diagnosis. Receives: Diagnostic Test: Psychological developmental assessment | |
| Genetic Conditions | Children with confirmed genetic conditions associated with developmental risk, based on medical documentation provided by parents or caregivers. Receives: Diagnostic Test: Psychological developmental assessment | |
| Moderate to Late Preterm | Children born preterm between 33 and 37 weeks of gestational age. This group includes infants and toddlers with a history of moderate to late prematurity, without severe neonatal complications requiring classification as extremely preterm. Receives: Diagnostic Test: Psychological developmental assessment | |
| Extremely Preterm | Children born before 33 weeks of gestational age. This group includes infants and toddlers with a history of extreme prematurity, associated with increased risk for developmental difficulties across multiple domains. Receives: Diagnostic Test: Psychological developmental assessment | |
| Cerebral Palsy | Children with a diagnosis of cerebral palsy documented in medical records. This group includes children with motor impairment of neurological origin, potentially accompanied by cognitive, language, or adaptive difficulties. Receives: Diagnostic Test: Psychological developmental assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive development
Cognitive functioning assessed using the Cognitive Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4). The scale evaluates early cognitive abilities, including sensory-motor processing, exploration and manipulation, object relations, memory, problem solving, and early executive functioning. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better cognitive development.
Measured: Baseline
Language Development
Language functioning assessed using the Language Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), including receptive and expressive communication abilities appropriate to the child's developmental level. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better language development.
Measured: Baseline
Motor Development
Motor functioning assessed using the Motor Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), including fine and gross motor skills related to coordination, posture, locomotion, and motor planning. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better motor development.
Measured: Baseline
Secondary outcomes (2)
Social-emotional functioning
Social-emotional development assessed using the Social-Emotional Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), based on parent-reported information regarding emotional regulation, social engagement, communication of needs, and relationship development. Data will be reported as a Scaled Score ranging from 1 to 19, where higher scores indicate better performance.
Measured: Baseline
Adaptive behavior functioning
Adaptive behavior assessed using the Adaptive Behavior Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), based on parent or caregiver report of the child's everyday functional skills in communication, daily living skills, and socialization. Data will be reported as a Scaled Score ranging from 1 to 19, where higher scores indicate better performance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start2 Jan 2025
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood DevelopmentStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartosz M. Radtke
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Bartosz M. Radtke, Laboratory of Psychological and Educational Tests
- Investigators
- Urszula Sajewicz-Radtke, Ph.D., Principal investigator, Laboratory of Psychological and Educational TestsBartosz M Radtke, Ph.D., Study director, Laboratory of Psychological and Educational TestsAriadna Łada-Maśko, Ph.D., Principal investigator, Laboratory of Psychological and Educational Tests
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418528
- Sponsor's protocol ID
- 2026/PTPiP/1
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Early Development: A Biopsychosocial Perspective on Infant and Toddler Functioning
- ClinicalTrials.gov ID
- NCT07418528
- Acronym / sponsor ID
- 2026/PTPiP/1
- Keywords
- Early development, Infant development, Toddler development, Neurodevelopment, Cognitive development, Language development, Motor development, Social-emotional development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Bartosz M. RadtkeOther government
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Feb 2026 (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.
The goal of this observational study is to analyze early development in infants and young children from a biopsychosocial perspective, with a particular focus on cognitive, language, motor, social-emotional, and adaptive functioning during the first years of life.
The study will include infants and young children from 16 days of age up to 42 months of age, assessed during a single diagnostic session conducted by qualified specialists. The developmental assessment will include standardized diagnostic tasks and direct observation of behavior in the form of play and natural interaction, carried out in the presence of a parent or legal guardian.
In addition, information regarding the child's everyday functioning will be collected from parents or caregivers using standardized questionnaires, including data on social-emotional competencies, communication, and adaptive skills.
The main research questions addressed by this study are:
What is the developmental profile of infants and young children in the first years of life?
What relationships exist between different domains of early development within a biopsychosocial model of child functioning?
Can specific developmental patterns be identified that indicate an increased risk of developmental difficulties in early childhood?
How does age differentiate the structure and variability of developmental functioning across assessed domains?
The study is non-invasive and observational in nature. Data will be analyzed exclusively in aggregated form and will contribute to a better understanding of early child development as well as to the development of norms and tools supporting early diagnosis and developmental intervention.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Diagnostic Test: Psychological developmental assessmentChildren without identified developmental delays, genetic conditions, or major perinatal complications, assessed as part of the general population. |
| Developmental Delay | – | Diagnostic Test: Psychological developmental assessmentChildren with identified developmental delay based on prior clinical assessment or referral information, without a confirmed specific genetic diagnosis. |
| Genetic Conditions | – | Diagnostic Test: Psychological developmental assessmentChildren with confirmed genetic conditions associated with developmental risk, based on medical documentation provided by parents or caregivers. |
| Moderate to Late Preterm | – | Diagnostic Test: Psychological developmental assessmentChildren born preterm between 33 and 37 weeks of gestational age. This group includes infants and toddlers with a history of moderate to late prematurity, without severe neonatal complications requiring classification as extremely preterm. |
| Extremely Preterm | – | Diagnostic Test: Psychological developmental assessmentChildren born before 33 weeks of gestational age. This group includes infants and toddlers with a history of extreme prematurity, associated with increased risk for developmental difficulties across multiple domains. |
| Cerebral Palsy | – | Diagnostic Test: Psychological developmental assessmentChildren with a diagnosis of cerebral palsy documented in medical records. This group includes children with motor impairment of neurological origin, potentially accompanied by cognitive, language, or adaptive difficulties. |
Who may qualify
- Ages
- 16 days to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants and young children aged 16 days to 42 months, including children with typical development and children with increased developmental risk.
Key inclusion criteria (6 listed)
- Infants and young children aged from 16 days to 42 months at the time of assessment.
- Participation of a parent or legal guardian able to provide informed consent.
- Child's ability to participate in a standardized developmental assessment appropriate for age and developmental level.
- Availability of basic medical and perinatal information provided by parents or caregivers.
- Assignment to one of the predefined study cohorts based on medical history and developmental status:
Key exclusion criteria (5 listed)
- Severe acute medical condition at the time of assessment preventing participation in the psychological evaluation.
- Uncorrected severe sensory impairments (e.g., profound visual or hearing impairment) that preclude valid administration or interpretation of the developmental assessment.
- Medical instability or conditions requiring immediate intensive medical care.
- Lack of informed consent from a parent or legal guardian.
- Inability of the parent or caregiver to provide reliable information required for questionnaire-based assessment.
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 |
|---|---|---|
| Psychological developmental assessmentAll participants undergo a standardized psychological developmental assessment conducted by trained specialists. The assessment includes structured diagnostic tasks and direct observation of the child's behavior during play and natural interaction, carried out in the presence of a parent or legal guardian. In addition, parents or caregivers complete standardized questionnaires assessing the child's social-emotional functioning and adaptive behavior. No experimental intervention or therapeutic procedure is applied. | Diagnostic test | Cerebral Palsy, Control Group, Developmental Delay, Extremely Preterm, Genetic Conditions, Moderate to Late Preterm |
Primary outcome
Cognitive development
Time frame: Baseline
Cognitive functioning assessed using the Cognitive Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4). The scale evaluates early cognitive abilities, including sensory-motor processing, exploration and manipulation, object relations, memory, problem solving, and early executive functioning. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better cognitive development.
Language Development
Time frame: Baseline
Language functioning assessed using the Language Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), including receptive and expressive communication abilities appropriate to the child's developmental level. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better language development.
Motor Development
Time frame: Baseline
Motor functioning assessed using the Motor Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), including fine and gross motor skills related to coordination, posture, locomotion, and motor planning. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better motor development.
2 secondary outcomes
Social-emotional functioning
Time frame: Baseline
Adaptive behavior functioning
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Urszula Sajewicz-Radtke, Ph.D. principal investigator
Laboratory of Psychological and Educational Tests
Bartosz M Radtke, Ph.D. study director
Laboratory of Psychological and Educational Tests
Ariadna Łada-Maśko, Ph.D. principal investigator
Laboratory of Psychological and Educational Tests
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 Early Childhood Development and Infant Development, run by Bartosz M. Radtke at 1 site in Poland.
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 6 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafał Nowicki, M.A. (+48509805591, nowicki@pracowniatestow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive development (time frame: Baseline). The study lists 3 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 23 Feb 2026.