Infant PrematureNCT04624347
NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants
A study testing Access to video and movement curves in people with Infant Premature and Growth and Development, run by Rennes University Hospital at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- Infant Premature, Growth and Development, Neurologic Disorder
- What is being tested?
- Access to video and movement curves
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Nov 2020to 22 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Pôle Femme Mère Enfant
Brest, 29200
CHU Rennes Hôpital Sud
Rennes, Brittany Region, 35000
About this study
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.
Read the 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.
- Being tested
- Access to video and movement curves
- Medical subject headings
- Premature Birth, Nervous System Diseases, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to video and movement curvesBehavioural
intervention of caregivers with access to videos and motion curves of the premature infant
| Study group | Role | What they receive |
|---|---|---|
| Acess to Videos and Movement curves | Experimental | with caregivers' access to videos and movement curves (4 days) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: for 8 days
Secondary outcomes (11)
Quantification of the ratio of time spent in calm sleep / time spent in restless sleep .
Prechtl stage 1 / stage 2 ratio
Measured: for 8 days
- Quantification of the percentage of time spent in the 5 stages of Prechtl / total analyzable tracing time.
Measured: for 8 days
- Quantification of sleep fragmentation and the different types of transitions: number and duration of awakening periods
Measured: 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)
movement periods = periods defined by successions of movements spaced less than 5 seconds apart
Measured: for 8 days
- Quantification of sleep fragmentation and the different types of transitions: classification of all transitions between stages
Measured: for 8 days
- Care interventions: Quantification of the number and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention)
Measured: for 8 days
- Care interventions: Quantification of the duration and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention)
Measured: for 8 days
- 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)
Measured: for 8 days
- Textual analysis (lexical field) of the interview with the parents on their feelings about the device
Measured: At the end of 8 days recordings
- Textual analysis (lexical field) of the interview with the nursery nurses on their feelings about the device
Measured: At the end of 8 days recordings
- 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.
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start17 Nov 2020
- Primary completion17 May 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant PrematureStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline CITTE, pediatric nurse, Principal investigator, University Hospital of Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624347
- Sponsor's protocol ID
- 35RC18_8855_NEOVIDEO
- Status last verified
- Apr 2024
- First submitted
- 5 Nov 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants
- ClinicalTrials.gov ID
- NCT04624347
- Acronym / sponsor ID
- 35RC18_8855_NEOVIDEO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Acess to Videos and Movement curves | Experimental | Behavioral: Access to video and movement curveswith caregivers' access to videos and movement curves (4 days) |
| No Acess to Video and Movement curves | No intervention | –without caregivers' access to videos and movement (4 days) |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
- having at least 1 year of practical experience in neonatology,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to video and movement curvesintervention of caregivers with access to videos and motion curves of the premature infant | Behavioural | Acess to Videos and Movement curves |
Primary outcome
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).
11 secondary outcomes
Quantification of the ratio of time spent in calm sleep / time spent in restless sleep .
Time frame: for 8 days
- Quantification of the percentage of time spent in the 5 stages of Prechtl / total analyzable tracing time.
Time frame: for 8 days
- Quantification of sleep fragmentation and the different types of transitions: number and duration of awakening periods
Time frame: 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)
Time frame: for 8 days
- Quantification of sleep fragmentation and the different types of transitions: classification of all transitions between stages
Time frame: for 8 days
- 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
- 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
- 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
- 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
- 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
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline CITTE, pediatric nurse principal investigator
University Hospital of Rennes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to video and movement curves in people with Infant Premature and Growth and Development, run by Rennes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of the percentage of time spent in sleep (time frame: for 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.