Clinical trial NCT04624347: NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants
Official title: NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Premature
Growth and Development
Neurologic Disorder
Sleep Fragmentation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 74
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantification of the percentage of time spent in sleep
timeFrame: for 8 days
Secondary outcomes:
measure: Quantification of the ratio of time spent in calm sleep / time spent in restless sleep .
timeFrame: for 8 days
measure: - Quantification of the percentage of time spent in the 5 stages of Prechtl / total analyzable tracing time.
timeFrame: for 8 days
measure: - Quantification of sleep fragmentation and the different types of transitions: number and duration of awakening periods
timeFrame: for 8 days
measure: - 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)
timeFrame: for 8 days
measure: - Quantification of sleep fragmentation and the different types of transitions: classification of all transitions between stages
timeFrame: for 8 days
measure: - Care interventions: Quantification of the number and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention)
timeFrame: for 8 days
measure: - Care interventions: Quantification of the duration and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention)
timeFrame: for 8 days
measure: - 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)
timeFrame: for 8 days
measure: - Textual analysis (lexical field) of the interview with the parents on their feelings about the device
timeFrame: At the end of 8 days recordings
measure: - Textual analysis (lexical field) of the interview with the nursery nurses on their feelings about the device
timeFrame: At the end of 8 days recordings
measure: - Analysis of the score of the "Ages and Stages questionnaires / Second Edition" sent to parents before their child's 24-month visit.
timeFrame: at 24 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes Hôpital Sud
state: Bretagne
city: Brest
country: France
facility: Pôle Femme Mère Enfant
Study officials:
affiliation: University Hospital of Rennes
name: Céline CITTE, pediatric nurse
role: PRINCIPAL_INVESTIGATOR
References: