PrematuritySPIN-NANCT07169110
Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants
An observational study of Prematurity, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 6 months
- Conditions the study is for
- Prematurity
- What is being tested?
- SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 6 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Intensive care /neonatology Toulouse Hospital
Toulouse, 31000
Corinne Alberge, 33 6 23 81 09 77 ext. +33, alberge.c@chu-toulouse.fr
Alice Pincon
About this study
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.
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.
Read the 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.
- Conditions
- Prematurity
- Being tested
- SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording
- Keywords
- Premature infant, early development, early care intervention, early evaluation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video RecordingOther
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 group | Role | What they receive |
|---|---|---|
| SPIN-NA Evaluation | Infants evaluated by SPIN-NA grid Receives: Other: SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the day 1 corresponding to the home video recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start22 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corine Alberge, Study director, University Hospital of ToulouseNathalie Noack, Study director, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169110
- Sponsor's protocol ID
- RC31/25/0578
- Other IDs
- ID-RCB : 2025-A00379-40
- Acronym
- SPIN-NA
- Status last verified
- Dec 2025
- First submitted
- 1 Aug 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07169110
- Acronym / sponsor ID
- SPIN-NA / RC31/25/0578
- Conditions
- Prematurity
- Keywords
- Premature infant, early development, early care intervention, early evaluation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 22 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPIN-NA Evaluation | – | Other: SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video RecordingInfants evaluated by SPIN-NA grid |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video RecordingThe 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. | Other | SPIN-NA Evaluation |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corine Alberge study director
University Hospital of Toulouse
Nathalie Noack study director
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadège Algans (0561777204 ext. +33, algans.n@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.