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

NCT ID: NCT04624347

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-17
• Study Completion Date: 2022-09-22

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.

Conditions

Infant Premature; Growth and Development; Neurologic Disorder; Sleep Fragmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Acess to Videos and Movement curves

with caregivers' access to videos and movement curves (4 days)

Group Type: EXPERIMENTAL

Access to video and movement curves

Intervention Type: BEHAVIORAL

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

No Acess to Video and Movement curves

without caregivers' access to videos and movement (4 days)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Access to video and movement curves

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Céline CITTE, pediatric nurse

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Rennes

Locations

CHU Rennes Hôpital Sud

Rennes, Brittany Region, France

Pôle Femme Mère Enfant

Brest, , France

Countries

France

Other Identifiers

35RC18_8855_NEOVIDEO

Identifier Type: -

Identifier Source: org_study_id