Actively Recruiting

Age: 16Days - 42Months
All Genders
Healthy Volunteers
NCT07418528

Understanding Early Development of Infants and Toddlers

Led by Bartosz M. Radtke · Updated on 2026-02-23

1200

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Understanding Early Development of Infants and Toddlers

Who Can Participate

Age: 16Days - 42Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Laboratory of Psychological and Educational Tests

Gdansk, Pomeranian Voivodeship, Poland, 80-239

Actively Recruiting

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Research Team

R

Rafał Nowicki, M.A.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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