Neonatal DisorderVARI-NEONATNCT03270410
Design of a Non-invasive Multi-modal Neonatal Monitoring System
An observational study of Neonatal Disorder, run by Rennes University Hospital at 1 site in France.
Trial summary
This is a preliminary study whose objectives are to define the clinical use cases and the constraints of the implementation of a multi-sensor image-sound system. Read more about this study
- Who is it for?
- Ages Up to 6 weeks
- Conditions the study is for
- Neonatal Disorder
- What is being tested?
- Data collection
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2015to 26 Oct 2016
- Phase
- Observational
- 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 Up to 6 weeks
- All sexes
- No healthy volunteers
- Child
Study population: This study is aimed at newborns hospitalized at the CHU in Rennes
Who may be able to join
- newborns less than 6 weeks old in corrected terms;
- newborns in one of the following situations:
- persistent discomfort (apneas);
- infection or suspicion of infection;
- premature with uncomplicated evolution;
- Premature brain lesion acquired in perinatal;
- newborn having been exposed to premature rupture of the membranes.
Who cannot join
- Congenital malformation;
- Metabolic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design of a Non-invasive Multi-modal Neonatal Monitoring System: Preliminary Observational Study
This is a preliminary study whose objectives are to define the clinical use cases and the constraints of the implementation of a multi-sensor image-sound system.
Read the detailed description
300 000 newborns per year are hospitalized in European neonatal units in the post-natal period. This is a critical period for neurobehavioral development and the establishment of an optimal model of sleep-wake cycle is fundamental for brain development.
The objective of the research is to develop new tools for computer-aided clinical and predictive diagnosis and real-time monitoring in neonatology.
The development of non-invasive sensors based on video and sound images aims to improve the short- and medium-term prognosis in perinatal patients.
To that aim, multi-modal composite indices integrating the image (which is used only to generate a quantification of the movement) and the sound to the bioelectric signals already available (electrocardiogram, oxymetry, temperature) will be developed to provide diagnostic and prognostic information.
- Conditions
- Neonatal Disorder
- Being tested
- Data collection
- Keywords
- neonates, non invasive monitoring
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
After parental information and collection of their non-opposition, the data of the daily cardio-respiratory recordings of the newborns hospitalized in the units of Neonatology are collected and analyzed.
At the same time, a video recording is set up. This video recording does not modify the care provided for the child, the organization of the day with nursing and parental care.
| Study group | Role | What they receive |
|---|---|---|
| Neonates | Babies born in Rennes University Hospital Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the cardiac variability during the stay in the ward
The cardiac signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of cardiac variability.
Measured: Up to 2 months
Secondary outcomes (2)
Evolution of the respiratory variability during the stay in the ward
The respiratory signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of respiratory variability.
Measured: Up to 2 months
Evolution of the babies' movements during the stay in the ward
Continuous video acquisitions of the newborns are realized. Video images will be analyzed by specific routines to extract quantitative parameters of movements.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start17 Sep 2015
- Primary completion26 Oct 2016
- Study completion26 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick PLADYS, MD, PhD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270410
- Sponsor's protocol ID
- 35RC15_3012
- Acronym
- VARI-NEONAT
- Status last verified
- Oct 2018
- First submitted
- 23 Aug 2017
- Last updated
- 2 Oct 2018
- 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 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Non-invasive Multi-modal Neonatal Monitoring System: Preliminary Observational Study
- ClinicalTrials.gov ID
- NCT03270410
- Acronym / sponsor ID
- VARI-NEONAT / 35RC15_3012
- Conditions
- Neonatal Disorder
- Keywords
- neonates, non invasive monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- 26 Oct 2016 (actual)
- Study completion
- 26 Oct 2016 (actual)
- First posted
- 1 Sep 2017 (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.
This is a preliminary study whose objectives are to define the clinical use cases and the constraints of the implementation of a multi-sensor image-sound system.
Detailed description
300 000 newborns per year are hospitalized in European neonatal units in the post-natal period. This is a critical period for neurobehavioral development and the establishment of an optimal model of sleep-wake cycle is fundamental for brain development.
The objective of the research is to develop new tools for computer-aided clinical and predictive diagnosis and real-time monitoring in neonatology.
The development of non-invasive sensors based on video and sound images aims to improve the short- and medium-term prognosis in perinatal patients.
To that aim, multi-modal composite indices integrating the image (which is used only to generate a quantification of the movement) and the sound to the bioelectric signals already available (electrocardiogram, oxymetry, temperature) will be developed to provide diagnostic and prognostic information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates | – | Other: Data collectionBabies born in Rennes University Hospital |
Who may qualify
- Ages
- Up to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study is aimed at newborns hospitalized at the CHU in Rennes
Key inclusion criteria (7 listed)
- newborns less than 6 weeks old in corrected terms;
- newborns in one of the following situations:
Key exclusion criteria (2 listed)
- Congenital malformation;
- Metabolic disease.
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 |
|---|---|---|
| Data collectionAfter parental information and collection of their non-opposition, the data of the daily cardio-respiratory recordings of the newborns hospitalized in the units of Neonatology are collected and analyzed. At the same time, a video recording is set up. This video recording does not modify the care provided for the child, the organization of the day with nursing and parental care. | Other | Neonates |
Primary outcome
Evolution of the cardiac variability during the stay in the ward
Time frame: Up to 2 months
The cardiac signals collected by the clinical monitoring required for hospitalization in a neonatal unit will be analyzed by specific routines to calculate parameters of cardiac variability.
2 secondary outcomes
Evolution of the respiratory variability during the stay in the ward
Time frame: Up to 2 months
Evolution of the babies' movements during the stay in the ward
Time frame: Up to 2 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 2 Oct 2018.
- 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.
Patrick PLADYS, MD, PhD study director
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Disorder, run by Rennes University Hospital at 1 site 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 7 inclusion and 2 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Evolution of the cardiac variability during the stay in the ward (time frame: Up to 2 months). 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 2 Oct 2018.