Clinical trial Recruiting at 1 site Observational Ages 16 Days to 42 Months

Understanding early development in infants and toddlers

Official title: Understanding Early Development: A Biopsychosocial Perspective on Infant and Toddler Functioning

Run by Laboratory of Psychological and Educational Tests · NCT07418528 · Data updated 2026-11-12

This project will try to describe cognitive, language, motor, social-emotional, and adaptive development in infants and toddlers aged 16 days to 42 months using a one-time developmental session and parent questionnaires.

Quick facts

Study typeObservational
Ages16 Days to 42 Months
SexAll
Enrollment1200 (estimated)
SponsorLaboratory of Psychological and Educational Tests
Government
Locations1 site (Gdansk, Pomeranian Voivodeship)
StatusRecruiting
StartedJanuary 2, 2025
Main results expectedNovember 2026
Study endsMarch 2027
Registry record updatedFebruary 23, 2026
Trial IDNCT07418528 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 16 days to 42 months whose parent or legal guardian can provide consent and who can participate in an age-appropriate standardized developmental assessment.

Probably not a fit

Children with a severe acute medical condition at the time of assessment, uncorrected profound sensory impairments, or those older than 42 months are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls infants and young children from 16 days to 42 months for a single, standardized diagnostic session conducted by qualified specialists. Assessments combine age-appropriate standardized tasks, direct behavioral observation during play and natural interaction, and parent- or caregiver-reported questionnaires about everyday functioning. Basic medical and perinatal history is recorded and participants are assigned to predefined cohorts (general population, developmental delay, confirmed genetic conditions, various prematurity groups, or cerebral palsy). Data will be used to map developmental profiles across cognitive, language, motor, social-emotional, and adaptive domains during the earliest years.

Why it matters

Potential benefit: If successful, the work could improve early identification of atypical developmental patterns and inform earlier referrals and supports for young children.

How similar studies have gone: Similar observational developmental cohorts have been widely used and have successfully characterized early developmental trajectories, so the approach is well established.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

  • Laboratory of Psychological and Educational Tests
    Gdansk, Pomeranian Voivodeship, Poland
    Recruiting

Study contacts

  • Principal investigator: Urszula Sajewicz-Radtke, Ph.D. — Laboratory of Psychological and Educational Tests
  • Study coordinator: Rafał Nowicki, M.A.
  • Email: nowicki@pracowniatestow.pl
  • Phone: +48509805591

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.