Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Developmen… (NCT07169110) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants
France35 participantsStarted 2025-12-22
Plain-language 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.
Who can participate
Age range
1 Month – 6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Inter-Rater Agreement on Developmental Difficulties Detection Using the SPIN-NA Grid Across 8 Observation Axes
Timeframe: At the day 1 corresponding to the home video recording