NCT07169110

Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants

Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants Aged 1 to 6 Months Corrected, for the Very Early Detection of Developmental Disorders.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 35 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 1 Month – 6 Months
• Healthy volunteers: Not accepted

Summary

The research concerns the study of the interprofessional reproducibility of a grid for observing the development of premature infants from 1 to 6 months corrected age. No tool is available to characterize the mechanisms of early developmental processes and their deviations. We propose an analytical observation grid of developmental mechanisms in the first few months, in order to identify warning signs of developmental deviations and help define the nature and type of early care for vulnerable infants.

Detailed description

Improving the development of premature babies is a challenge. Developmental disabilities are common. Brain damage accounts for only a small proportion of disorders. Other factors have a major influence on the outcome: immaturity, an intrusive and stressful hospital environment, and parental socio-psychological conditions. Early sensory-motor disorders disrupt development. The high degree of cerebral plasticity in infants means that early care is essential if developmental trajectories are to be improved. Intervention programmes are heterogeneous. Meta-analyses therefore make only limited comparisons. The cognitive and behavioural benefits are variable. Motor benefits are low. No tools are available to determine the mechanisms of early developmental processes. The SPIN-NA grid is a scale for analytical observation of developmental processes from 1 to 6 months corrected age to identify early warning signs and determine early care (nature, areas of care, objectives). The aim is to study the inter-professional reproducibility of the grid. This validation stage is essential if the grid is to serve as a reference tool in psychomotricity for vulnerable newborns. Premature babies born between 27 and 32 gestational weeks will be assessed using the SPIN-NA grid by 5 experienced psychomotor-therapists, on the basis of videos taken at home between 1 and 6 months corrected age, by the creators of the grid. Each child was filmed only once. The inter-observer agreement should be at least 70% for the 8 observation axes defined in the SPIN-NA grid.

Conditions

• Prematurity

Interventions

Type	Name	Description
OTHER	SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording	The SPIN-NA intervention consists of an analytical assessment of development using a standardized clinical observation grid. Infants are filmed at home once between 1 and 6 months of corrected age in their family environment by the creators of the grid. The filmed observation includes structured observation scenarios designed to assess eight areas of development: stress signals, physiological and tonic regulation, perceptual abilities of different sensory channels, exploratory appetite, manipulative activities, child interactions and communication, emotional expressions and expressiveness, parent-child interactions: parental adaptation to the child's behavior.The videos are evaluated independently by five experienced psychomotor therapists trained together in the use of the SPINNA grid. No treatment or physical intervention is administered; the intervention is observational and non-invasive, aimed at validating the reproducibility of the grid in a real-world context.

Timeline

• Start date: 2025-12-22
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2025-09-11
• Last updated: 2025-12-18

Locations

1 site across 1 country: France