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

ConditionPrematurity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-6
SponsorUniversity Hospital, Toulouse

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording

    Other intervention

    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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: SPIN-NA Evaluation1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At the day 1 corresponding to the home video recording

Secondary outcomes

1

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.

Time frame
At the day 1 corresponding to the home video recording

Other outcomes

Sponsors and contacts

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