Infant, PrematureDigi-NewBNCT02863978
Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database
A study testing Multimodal signal acquisitions in people with Infant, Premature, run by Rennes University Hospital at 6 sites in France.
Trial summary
Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic. Read more about this study
- Who is it for?
- Ages Up to 6 weeks
- Conditions the study is for
- Infant, Premature
- What is being tested?
- Multimodal signal acquisitions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 746 participants
- Where
- 6 sitesFrance
- Study dates
- 8 Nov 2016to 21 Jan 2026
- 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 Up to 6 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn hospitalised in the neonatology services of participating hospitals
- One of the legal representatives gave its signed agreement to take part to the study
- New born aged of less than 6 weeks in corrected term
Who cannot join
- No signed agreement from the legal representative
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Angers University Hospital
Angers, 49000
Brest University Hospital
Brest, Brittany Region, 29609
Nantes University Hospital
Nantes, 44000
Poitiers University Hospital
Poitiers, 86000
Rennes University Hospital
Rennes, 35000
Tours University Hospital
Tours, 37000
About this study
Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic. The Rennes University Hospital was granted a specific funding from the European Union in the framework of the Horizon 2020 programme (Call PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to develop the Digi-NewB project. This project aims to develop innovative non-invasive monitoring tools to support decision making in health. Such tools include a new generation of real time monitoring in neonatology using composite indices made of cardio-respiratory variables, movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all physiological data relevant for the creation of the composite indices.
Read the detailed description
The database will be used to answer the following specific objectives, with priority given to the two first ones (sepsis and maturation) :
- Early diagnosis of sepsis for the following cases : Late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis
- Cardio-respiratory and neurobehavioral maturation (movements, sleeping cycles)
- Influence of environmental factors and developmental care on selected parameters
- Influence on care organisation of the possibility to access videos and movement analyses by medical teams
- Influence of glycemia on selected parameters
- Influence of neurological lesions and broncho-pulmonary dysplasia on selected parameters
- Indices correlation with medical images MRI (T1, T2, diffusion, Arterial Spin Labelling) from neonatal units and with health evaluated after 1 and 2 years with the Ages \& Stages Questionnaires (ASQ)
- Evaluation of the acquisition system's user-friendliness
- Conditions
- Infant, Premature
- Being tested
- Multimodal signal acquisitions
- Keywords
- Sepsis, Neonates, Cardio-respiratory maturation, Neurobehavioral maturation
- Medical subject headings
- Premature Birth, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal signal acquisitionsOther
Cardiac and respiratory signals are collected from the clinical monitoring routinely gathered in hospital neonatal units.
Movement quantification and baby's sounds are extracted thanks to a dedicated system which will collect images and sound with microphones and cameras.
| Study group | Role | What they receive |
|---|---|---|
| Digi-NewB Cohort | Experimental | Multimodal signal acquisitions Receives: Other: Multimodal signal acquisitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of newborns in neonatology unit
Measured: Four years
Secondary outcomes (9)
Infection/Sepsis
Identification of late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis
Measured: During the stay in neonatal unit, up to 10 weeks
Maturation
Quantification of maturation, i.e. evaluation of cardio respiratory rates and neurobehavioral maturation
Measured: During the stay in neonatal unit, up to 10 weeks
Influence of environment and developmental care
Measure of impact of access to new variables (maturation, rates) on care organisation and system's perception by families (Likert scales)
Measured: During the stay in neonatal unit, up to 10 weeks
Care givers satisfaction
Evaluation of carers' satisfaction with the new variables and the system's relevance in relation to their needs ("use cases" methods)
Measured: Each 6 months after setting up the acquisition system in the unit
Impact on newborn's time of quiet sleep
Quantification of the relative time of quiet sleep
Measured: At the end of the stay in neonatal unit, up to 10 weeks
Glycemia
Measures of physiological impact of hypo and hyperglycemias to assess the predictive value of hyperglycemia on sepsis risk
Measured: During the stay in neonatal unit, up to 10 weeks
Cerebral Electrophysiology
Compared evaluation of data coming from Digi-NewB cohort with available data from EEG and polysomnography (impact of cerebral damages, broncho-pulmonary dysplasia)
Measured: During the stay in neonatal unit, up to 10 weeks
Medium term Prognosis
Acquisition of magnetic resonance images (T1, T2, diffusion and cerebral perfusion arterial spin labeling) in neonatology
Measured: During the stay in neonatal unit, up to 10 weeks
Prognosis evaluation
Assessment of the baby's neuro-development by Ages \& Stages Questionnaires® (ASQ) and health related events (hospitalisation, growth...)
Measured: At the babies 1st and 2nd birthdays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start8 Nov 2016
- Primary completion10 Jun 2020
- Study completion21 Jan 2026
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, GCS Hôpitaux Universitaires Grand-Ouest, University of Rennes, Tampere University of Technology, Voxygen Health, INESC TEC Porto, National University of Ireland, Galway, Ireland, Synchrophi Systems Ltd
- Responsible party
- Sponsor
- Investigators
- Patrick PLADYS, MD, PhD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863978
- Sponsor's protocol ID
- 35RC16_9714
- Other IDs
- 2016-A00993-48
- Acronym
- Digi-NewB
- Status last verified
- Jun 2026
- First submitted
- 3 Aug 2016
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database
- ClinicalTrials.gov ID
- NCT02863978
- Acronym / sponsor ID
- Digi-NewB / 35RC16_9714
- Conditions
- Infant, Premature
- Keywords
- Sepsis, Neonates, Cardio-respiratory maturation, Neurobehavioral maturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 746 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- European Union, GCS Hôpitaux Universitaires Grand-Ouest, University of Rennes, Tampere University of Technology, Voxygen Health, INESC TEC Porto, National University of Ireland, Galway, Ireland, Synchrophi Systems Ltd
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 11 Aug 2016 (estimated)
- 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.
Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic. The Rennes University Hospital was granted a specific funding from the European Union in the framework of the Horizon 2020 programme (Call PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to develop the Digi-NewB project. This project aims to develop innovative non-invasive monitoring tools to support decision making in health. Such tools include a new generation of real time monitoring in neonatology using composite indices made of cardio-respiratory variables, movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all physiological data relevant for the creation of the composite indices.
Detailed description
The database will be used to answer the following specific objectives, with priority given to the two first ones (sepsis and maturation) :
- Early diagnosis of sepsis for the following cases : Late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis
- Cardio-respiratory and neurobehavioral maturation (movements, sleeping cycles)
- Influence of environmental factors and developmental care on selected parameters
- Influence on care organisation of the possibility to access videos and movement analyses by medical teams
- Influence of glycemia on selected parameters
- Influence of neurological lesions and broncho-pulmonary dysplasia on selected parameters
- Indices correlation with medical images MRI (T1, T2, diffusion, Arterial Spin Labelling) from neonatal units and with health evaluated after 1 and 2 years with the Ages \& Stages Questionnaires (ASQ)
- Evaluation of the acquisition system's user-friendliness
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digi-NewB Cohort | Experimental | Other: Multimodal signal acquisitionsMultimodal signal acquisitions |
Who may qualify
- Ages
- Up to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborn hospitalised in the neonatology services of participating hospitals
- One of the legal representatives gave its signed agreement to take part to the study
- New born aged of less than 6 weeks in corrected term
Key exclusion criteria (1 listed)
- No signed agreement from the legal representative
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 |
|---|---|---|
| Multimodal signal acquisitionsCardiac and respiratory signals are collected from the clinical monitoring routinely gathered in hospital neonatal units. Movement quantification and baby's sounds are extracted thanks to a dedicated system which will collect images and sound with microphones and cameras. | Other | Digi-NewB Cohort |
Primary outcome
Number of newborns in neonatology unit
Time frame: Four years
9 secondary outcomes
Infection/Sepsis
Time frame: During the stay in neonatal unit, up to 10 weeks
Maturation
Time frame: During the stay in neonatal unit, up to 10 weeks
Influence of environment and developmental care
Time frame: During the stay in neonatal unit, up to 10 weeks
Care givers satisfaction
Time frame: Each 6 months after setting up the acquisition system in the unit
Impact on newborn's time of quiet sleep
Time frame: At the end of the stay in neonatal unit, up to 10 weeks
Glycemia
Time frame: During the stay in neonatal unit, up to 10 weeks
Cerebral Electrophysiology
Time frame: During the stay in neonatal unit, up to 10 weeks
Medium term Prognosis
Time frame: During the stay in neonatal unit, up to 10 weeks
Prognosis evaluation
Time frame: At the babies 1st and 2nd birthdays
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 23 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal signal acquisitions in people with Infant, Premature, run by Rennes University Hospital at 6 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 3 inclusion and 1 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Number of newborns in neonatology unit (time frame: Four years). 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 23 Jun 2026.