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

NCT07169110 | Not Yet Recruiting

• 2 other identifiers: RC31/25/0578ID-RCB : 2025-A00379-40
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prematurity

Keywords

Premature infant; early development; early care intervention; early evaluation

Outcome Measures

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.

  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

  At the day 1 corresponding to the home video recording

Study Arms (1)

SPIN-NA Evaluation

Infants evaluated by SPIN-NA grid

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

Interventions

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

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.

SPIN-NA Evaluation

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Intensive care /neonatology Toulouse Hospital

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Corine Alberge

  University Hospital of Toulouse

  STUDY DIRECTOR

• Nathalie Noack

  University Hospital of Toulouse

  STUDY DIRECTOR

Central Study Contacts

Nadège Algans

CONTACT

0561777204; algans.n@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: September 11, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)