Skip to main content
OpenTrials
Completed

NCT Number: NCT04624347

NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of 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 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Access to video and movement curves

Behavioral

intervention of caregivers with access to videos and motion curves of the premature infant

Primary outcomes

  1. Quantification of the percentage of time spent in sleep

    Time frame: for 8 days

    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).

Secondary outcomes

  1. Quantification of the ratio of time spent in calm sleep / time spent in restless sleep .

    Time frame: for 8 days

    Prechtl stage 1 / stage 2 ratio

  2. - Quantification of the percentage of time spent in the 5 stages of Prechtl / total analyzable tracing time.

    Time frame: for 8 days

  3. - Quantification of sleep fragmentation and the different types of transitions: number and duration of awakening periods

    Time frame: for 8 days

  4. - 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)

    Time frame: for 8 days

    movement periods = periods defined by successions of movements spaced less than 5 seconds apart

  5. - Quantification of sleep fragmentation and the different types of transitions: classification of all transitions between stages

    Time frame: for 8 days

  6. - Care interventions: Quantification of the number and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention)

    Time frame: for 8 days

  7. - Care interventions: Quantification of the duration and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention)

    Time frame: for 8 days

  8. - 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)

    Time frame: for 8 days

  9. - Textual analysis (lexical field) of the interview with the parents on their feelings about the device

    Time frame: At the end of 8 days recordings

  10. - Textual analysis (lexical field) of the interview with the nursery nurses on their feelings about the device

    Time frame: At the end of 8 days recordings

  11. - Analysis of the score of the "Ages and Stages questionnaires / Second Edition" sent to parents before their child's 24-month visit.

    Time frame: at 24 months

    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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2020
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.