About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female child born between 27 and 32 weeks of amenorrhea in a singleton pregnancy;
Child hospitalized in the neonatology unit of Toulouse University Hospital;
Family home within a 15 km radius of Toulouse to allow for home visits for filming;
Parents with parental authority affiliated with a social security scheme or equivalent;
Disqualifiers
The child may participate in another study during the duration of this study, without an exclusion period.
Child with a severe organic pathology detected during hospitalization and requiring specific and appropriate care for the diagnosed pathology;
Child with a neurological complication: Grade 3 or 4 intraventricular hemorrhage, periventricular cavitary leukomalacia, excluding frontal leukomalacia;
Child with a malformation or multiple malformations that impair the neurological prognosis;
Trial population
Participants will be selected from infants born and hospitalized in the neonatology department of Toulouse University Hospital. The study targets a local population, with families residing within a 15-kilometer radius of Toulouse to allow for home-based video recording.
Trial design
Case-only
Prospective
Treatments tested in this trial
SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Inter-Rater Agreement on Developmental Difficulties Detection Using the SPIN-NA Grid Across 8 Observation Axes
The primary outcome is the overall percentage of agreement between raters, calculated as the mean of agreement rates across all evaluator pairs. Agreement is defined as both raters assigning the same classification (presence or absence of anomaly) to a given infant for a given axis.
Secondary outcomes
Inter-Rater Agreement on SPIN-NA Grid Evaluations by Age Group at the time of evaluation : 1-3 Months vs. 4-6 Months Corrected Age
Inter-rater agreement will be assessed separately for two age groups of infants: 1-3 months and 4-6 months corrected age. Each of the five trained psychomotor therapists will independently evaluate all infants in both age groups using the SPIN-NA grid. For each developmental axis, agreement is defined as two raters assigning the same classification (presence or absence of anomaly) to the same child. Agreement will be expressed as the mean percentage of agreement across all evaluator pairs for each age group. This analysis aims to explore whether the reproducibility of SPIN-NA assessments varies depending on the infant's age at the time of observation.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: