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Completed

NCT Number: NCT02863978

Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database

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.

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Key information

Conditions

Infant, Premature Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

Up to 6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brest University Hospital, Brest, Brittany Region, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • No signed agreement from the legal representative

Treatment and study plan

Multimodal signal acquisitions

Other

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.

Primary outcomes

  1. Number of newborns in neonatology unit

    Time frame: Four years

Secondary outcomes

  1. Infection/Sepsis

    Time frame: During the stay in neonatal unit, up to 10 weeks

    Identification of late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis

  2. Maturation

    Time frame: During the stay in neonatal unit, up to 10 weeks

    Quantification of maturation, i.e. evaluation of cardio respiratory rates and neurobehavioral maturation

  3. Influence of environment and developmental care

    Time frame: During the stay in neonatal unit, up to 10 weeks

    Measure of impact of access to new variables (maturation, rates) on care organisation and system's perception by families (Likert scales)

  4. Care givers satisfaction

    Time frame: Each 6 months after setting up the acquisition system in the unit

    Evaluation of carers' satisfaction with the new variables and the system's relevance in relation to their needs ("use cases" methods)

  5. Impact on newborn's time of quiet sleep

    Time frame: At the end of the stay in neonatal unit, up to 10 weeks

    Quantification of the relative time of quiet sleep

  6. Glycemia

    Time frame: During the stay in neonatal unit, up to 10 weeks

    Measures of physiological impact of hypo and hyperglycemias to assess the predictive value of hyperglycemia on sepsis risk

  7. Cerebral Electrophysiology

    Time frame: During the stay in neonatal unit, up to 10 weeks

    Compared evaluation of data coming from Digi-NewB cohort with available data from EEG and polysomnography (impact of cerebral damages, broncho-pulmonary dysplasia)

  8. Medium term Prognosis

    Time frame: During the stay in neonatal unit, up to 10 weeks

    Acquisition of magnetic resonance images (T1, T2, diffusion and cerebral perfusion arterial spin labeling) in neonatology

  9. Prognosis evaluation

    Time frame: At the babies 1st and 2nd birthdays

    Assessment of the baby's neuro-development by Ages & Stages Questionnaires® (ASQ) and health related events (hospitalisation, growth...)

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • European Union
  • GCS Hôpitaux Universitaires Grand-Ouest
  • INESC TEC Porto
  • National University of Ireland, Galway, Ireland
  • Synchrophi Systems Ltd
  • Tampere University of Technology
  • University of Rennes
  • Voxygen Health

Registry information

Acronym: Digi-NewB

Important dates

Study start
2016
Primary completion
2020
Study completion
2026
First posted
Aug 11, 2016
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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