Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT07296003
Brief Summary:
This study examines how early motor behavior in infants relates to their later psychomotor development. Researchers will observe both preterm and full-term infants during the first months of life, using video-based assessments to evaluate spontaneous movements and early postural control. These early motor patterns will be scored with the Motor Optimality Score - Revised (MOS-R).
When the children reach 18 and 36 months of age, their development in areas such as motor skills, communication, sensory processing, and social behavior will be evaluated through a caregiver-completed questionnaire.
The purpose of the study is to determine whether early motor quality can predict later developmental outcomes, whether preterm and full-term infants with similar motor scores develop differently, and whether early therapy may improve outcomes for infants with low MOS-R results.
Detailed Description:
This study uses a combined retrospective-prospective observational design. The retrospective component includes previously recorded video assessments of spontaneous motor behavior and postural control collected during routine clinical examinations in both preterm infants and a comparison group of full-term infants. These recordings were originally obtained as part of standard care in the neonatal unit and physiotherapy outpatient clinic and were subsequently anonymized for research purposes. Early motor quality was evaluated using standardized scoring procedures, including the Motor Optimality Score - Revised (MOS-R) and detailed general movement assessment.
The prospective component is used to complete developmental follow-up. Caregivers are contacted when the child reaches 18 and 36 months of age and are asked to complete a validated questionnaire assessing domains such as motor development, communication, sensory processing, and socio-emotional functioning. By integrating retrospective motor assessments with prospective developmental outcomes, the study enables a rigorous analysis of the predictive relationship between early motor patterns and later psychomotor development.
A combined design is necessary because high-quality video recordings of early motor behavior cannot be reproduced once the infant has aged, and the early spontaneous movement repertoire represents a unique neurodevelopmental window. The retrospective use of existing recordings reduces participant burden and allows comparison between preterm infants and full-term infants who underwent the same standardized motor assessment. The prospective follow-up ensures that developmental outcomes are measured consistently and with sufficient temporal precision. Overall, this design increases feasibility, minimizes risk, and provides a robust framework for evaluating early markers of developmental trajectories.
Study:
NCT07296003
Study Brief:
Protocol Section:
NCT07296003