Neurologic Disorder Clinical Trial
Official title:
NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants
Verified date | April 2024 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Very premature birth and the necessary hospitalization expose to a risk of morbidity and mortality which impacts the neurodevelopmental prognosis. Sleep and behavior monitoring have not been developed in the neonatal units. This has to be improved since it is known from clinical and animal studies that the quality, organization and quantity of sleep in very preterm infants impact neurological development and brain plasticity. The collection system provide neonatal care nurse with access to motion curves (evaluated by signal processing of live video) and real-time infrared video (also available in low-light conditions). This new non-invasive technology allows an evaluation of the activity cycles of the newborn by the caregivers which until now was only accessible occasionally by short recordings of actigraphy or polysomnography. The investigators wish to demonstrate that this can contribute to an organization of care that respects the sleep patterns of the newborn, which they know to condition the neurodevelopmental prognosis.
Status | Completed |
Enrollment | 74 |
Est. completion date | September 22, 2022 |
Est. primary completion date | May 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 23 Weeks to 32 Weeks |
Eligibility | Inclusion Criteria: New born : - hospitalized in neonatology, - at least one of whose legal representatives has given free, informed and written consent, - term of birth <32 WA, postnatal age> 15 days and post-conceptual age between [30-38] WA, - affiliated to a social security scheme Caregivers: - having at least 1 year of practical experience in neonatology, - having been trained in the clinical basics of evaluating newborn sleep, - having given their consent to participate. Exclusion Criteria: New born : - sedative or curare treatment (opiates, benzodiazepines, curare, barbiturates) in the last 24 hours, - chromosomal abnormalities identified - Planned discharge date incompatible with the completion of the entire study No criteria for caregivers |
Country | Name | City | State |
---|---|---|---|
France | Pôle Femme Mère Enfant | Brest | |
France | CHU Rennes Hôpital Sud | Rennes | Bretagne |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantification of the percentage of time spent in sleep | Quantification of the percentage of time spent in sleep (stage 1 + 2 of the neurobehavioral classification of Prechtl in 5 stages compared to the total duration of the analyzable tracing) by a supervised expert, viewing the blinded sequences of the condition tested (with and without access caregivers to video and movement curves). | for 8 days | |
Secondary | Quantification of the ratio of time spent in calm sleep / time spent in restless sleep . | Prechtl stage 1 / stage 2 ratio | for 8 days | |
Secondary | - Quantification of the percentage of time spent in the 5 stages of Prechtl / total analyzable tracing time. | for 8 days | ||
Secondary | - Quantification of sleep fragmentation and the different types of transitions: number and duration of awakening periods | for 8 days | ||
Secondary | - Quantification of sleep fragmentation and the different types of transitions: number and duration of movement periods (periods defined by successions of movements spaced less than 5 seconds apart) | movement periods = periods defined by successions of movements spaced less than 5 seconds apart | for 8 days | |
Secondary | - Quantification of sleep fragmentation and the different types of transitions: classification of all transitions between stages | for 8 days | ||
Secondary | - Care interventions: Quantification of the number and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention) | for 8 days | ||
Secondary | - Care interventions: Quantification of the duration and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention) | for 8 days | ||
Secondary | - Care interventions: Quantification of the type (noise or manual intervention) and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention) | for 8 days | ||
Secondary | - Textual analysis (lexical field) of the interview with the parents on their feelings about the device | At the end of 8 days recordings | ||
Secondary | - Textual analysis (lexical field) of the interview with the nursery nurses on their feelings about the device | At the end of 8 days recordings | ||
Secondary | - Analysis of the score of the "Ages and Stages questionnaires / Second Edition" sent to parents before their child's 24-month visit. | Evaluate the child's skills in the various areas of his development. Questionnaire with 5 sections (Communication, Gross motor skills,Fine motor skills,Problem solving, Individual or social skills).
Results sheet allowing rapid interpretation (positivity threshold for each sphere) and recommendations for each developmental area screened. |
at 24 months |
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