NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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According to the EuroPeristat 2014 report, 1% of births are very preterm infants. 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 publications suggest that alterations in sleep could have a significant impact on acquisitions in the areas of learning, memory, sensory development and behavior, as well as in the area of cardiorespiratory regulation. It has been shown that the implementation of developmental care practices (taking into account lighting, noise, the position of newborns and their rhythms) could have short-term beneficial effects on the sleep of very preterm infants. However, studies remain very limited in number. The investigators propose to build on the infrastructure developed as part of the H2020 DigiNewB project (http://www.digi-newb.eu/), which can provide neonatal care providers with access to motion curves (evaluated by signal processing of live video) and real-time infrared video (also available in low-light conditions).The collection system is functional, allows continuous analysis of videos to quantify movement and is suitable for incubators and neonatal beds. 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.

Official Title
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NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants

Conditions
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Infant Premature, Growth and Development, Neurologic Disorder, Sleep Fragmentation

Intervention / Treatment
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* Behavioral: Access to video and movement curves


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Controlled, bicentric, single-blind, cross-over study with randomization of the sequence order (with and without caregivers' access to videos and movement curves).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acess to Videos and Movement curves<br>with caregivers' access to videos and movement curves (4 days) | Behavioral: Access to video and movement curves<br>* intervention of caregivers with access to videos and motion curves of the premature infant<br>|
| No Intervention: No Acess to Video and Movement curves<br>without caregivers' access to videos and movement (4 days) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the ratio of time spent in calm sleep / time spent in restless sleep . | Prechtl stage 1 / stage 2 ratio | for 8 days | 
| - Quantification of the percentage of time spent in the 5 stages of Prechtl / total analyzable tracing time. |  | for 8 days | 
| - Quantification of sleep fragmentation and the different types of transitions: number and duration of awakening periods |  | for 8 days | 
| - 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 | 
| - Quantification of sleep fragmentation and the different types of transitions: classification of all transitions between stages |  | for 8 days | 
| - Care interventions: Quantification of the number and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention) |  | for 8 days | 
| - Care interventions: Quantification of the duration and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention) |  | for 8 days | 
| - 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 | 
| - Textual analysis (lexical field) of the interview with the parents on their feelings about the device |  | At the end of 8 days recordings | 
| - Textual analysis (lexical field) of the interview with the nursery nurses on their feelings about the device |  | At the end of 8 days recordings | 
| - 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 |