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

NCT04624347 | Completed

• 1 other identifier: 35RC18_8855_NEOVIDEO
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

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

  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)

  for 8 days

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

  for 8 days

Study Arms (2)

Acess to Videos and Movement curves

EXPERIMENTAL

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

Behavioral: Access to video and movement curves

No Acess to Video and Movement curves

NO INTERVENTION

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

Interventions

Access to video and movement curves BEHAVIORAL

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

Acess to Videos and Movement curves

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (2)

CHU Rennes Hôpital Sud

Rennes, Brittany Region, 35000, France

Location

Pôle Femme Mère Enfant

Brest, 29200, France

Location

MeSH Terms

Conditions

Premature Birth; Nervous System Diseases; Sleep Deprivation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Céline CITTE, pediatric nurse

  University Hospital of Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled, bicentric, single-blind, cross-over study with randomization of the sequence order (with and without caregivers' access to videos and movement curves).

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 10, 2020
• Study Start: November 17, 2020
• Primary Completion: May 17, 2022
• Study Completion: September 22, 2022
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)