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Clinical Trials in France / NCT07169110
Starting soon Observational

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

NCT07169110 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-12-22
Last updated
2025-12-18

Condition(s) studied

Prematurity

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
1 Month
Max age
6 Months
Healthy volunteers
No
Inclusion Criteria: * 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; * Signature of the informed consent form by the parents with parental authority * Absence of serious illness, as defined in the exclusion criteria; * The child may participate in another study during the duration of this study, without an exclusion period. Exclusion Criteria: * 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; * Child with genetic or metabolic diseases; * Fetal alcohol syndrome; * Parental authority holders under guardianship, curatorship, or legal protection; * Any family condition that prevents compliance with the procedures set out in the study protocol, in the opinion of the investigator. * Family members who do not speak French fluently, in order to ensure understanding of the system and the proposed care.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Intensive care /neonatology Toulouse Hospital Toulouse France

More University Hospital, Toulouse trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07169110 on ClinicalTrials.gov ↗ ← All trials in France