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

Official title

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.

Overview

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.

Interventions

• 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, manip

Primary outcome measures

• Inter-Rater Agreement on Developmental Difficulties Detection Using the SPIN-NA Grid Across 8 Observation Axes [Time frame: At the day 1 corresponding to the home video recording]

Secondary outcome measures (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 [Time frame: At the day 1 corresponding to the home video recording]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

France · 1 center

• Intensive care /neonatology Toulouse Hospital — Toulouse

Identifiers

NCT: NCT07169110 · RC31/25/0578 · ID-RCB : 2025-A00379-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗