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

Neurologic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04624347
• Other study ID #: 35RC18_8855_NEOVIDEO
• Status: Completed
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: September 22, 2022

Study information

• Verified date: April 2024
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Growth and Development
• Infant Premature
• Nervous System Diseases
• Neurologic Disorder
• Sleep Deprivation
• Sleep Fragmentation

Intervention

Behavioral:
• Access to video and movement curves
intervention of caregivers with access to videos and motion curves of the premature infant

Locations

Country	Name	City	State
France	Pôle Femme Mère Enfant	Brest
France	CHU Rennes Hôpital Sud	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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