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

Primary Purpose

Infant Premature, Growth and Development, Neurologic Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Access to video and movement curves
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant Premature

Eligibility Criteria

23 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Rennes Hôpital SudRecruiting
  • Pôle Femme Mère EnfantRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acess to Videos and Movement curves

No Acess to Video and Movement curves

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Quantification of the ratio of time spent in calm sleep / time spent in restless sleep .
Prechtl stage 1 / stage 2 ratio
- Quantification of the percentage of time spent in the 5 stages of Prechtl / total analyzable tracing time.
- Quantification of sleep fragmentation and the different types of transitions: number and duration of awakening periods
- 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
- Quantification of sleep fragmentation and the different types of transitions: classification of all transitions between stages
- Care interventions: Quantification of the number and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention)
- Care interventions: Quantification of the duration and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention)
- 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)
- Textual analysis (lexical field) of the interview with the parents on their feelings about the device
- Textual analysis (lexical field) of the interview with the nursery nurses on their feelings about the device
- 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.

Full Information

First Posted
November 5, 2020
Last Updated
April 13, 2021
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04624347
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 17, 2020 (Actual)
Primary Completion Date
May 17, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Premature, Growth and Development, Neurologic Disorder, Sleep Fragmentation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acess to Videos and Movement curves
Arm Type
Experimental
Arm Description
with caregivers' access to videos and movement curves (4 days)
Arm Title
No Acess to Video and Movement curves
Arm Type
No Intervention
Arm Description
without caregivers' access to videos and movement (4 days)
Intervention Type
Behavioral
Intervention Name(s)
Access to video and movement curves
Intervention Description
intervention of caregivers with access to videos and motion curves of the premature infant
Primary Outcome Measure Information:
Title
Quantification of the percentage of time spent in sleep
Description
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).
Time Frame
for 8 days
Secondary Outcome Measure Information:
Title
Quantification of the ratio of time spent in calm sleep / time spent in restless sleep .
Description
Prechtl stage 1 / stage 2 ratio
Time Frame
for 8 days
Title
- Quantification of the percentage of time spent in the 5 stages of Prechtl / total analyzable tracing time.
Time Frame
for 8 days
Title
- Quantification of sleep fragmentation and the different types of transitions: number and duration of awakening periods
Time Frame
for 8 days
Title
- 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)
Description
movement periods = periods defined by successions of movements spaced less than 5 seconds apart
Time Frame
for 8 days
Title
- Quantification of sleep fragmentation and the different types of transitions: classification of all transitions between stages
Time Frame
for 8 days
Title
- 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
Title
- 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
Title
- 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
Title
- 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
Title
- 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
Title
- Analysis of the score of the "Ages and Stages questionnaires / Second Edition" sent to parents before their child's 24-month visit.
Description
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.
Time Frame
at 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Pladys, PHD/MD
Phone
0299265986
Email
patrick.pladys@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès GAZZOLA
Phone
0299289194
Email
agnes.gazzola@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline CITTE, pediatric nurse
Organizational Affiliation
University Hospital of Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes Hôpital Sud
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celine CITTE, Pediatric Nurse
Email
celine.citte@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Patrick PLADYS, PHD
Email
patrick.pladys@chu-rennes.fr
Facility Name
Pôle Femme Mère Enfant
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine ROUDAUT, Study Nurse
Phone
06 15 98 07 70
Email
sandrine.roudaut@chu-brest.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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