Infant, Premature Clinical Trial
Official title:
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.
The database will be used to answer the following specific objectives, with priority given to the two first ones (sepsis and maturation) : 1. Early diagnosis of sepsis for the following cases : Late onset sepsis of premature newborns, materno-fœtal sepsis, and newborn infection by chorioamnionitis 2. Cardio-respiratory and neurobehavioral maturation (movements, sleeping cycles) 3. Influence of environmental factors and developmental care on selected parameters 4. Influence on care organisation of the possibility to access videos and movement analyses by medical teams 5. Influence of glycemia on selected parameters 6. Influence of neurological lesions and broncho-pulmonary dysplasia on selected parameters 7. 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) 8. Evaluation of the acquisition system's user-friendliness ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03146351 -
The Effects of Family Centered Intervention Program on Preterm Infants
|
N/A | |
Completed |
NCT02064712 -
Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates
|
N/A | |
Completed |
NCT00365703 -
Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?
|
N/A | |
Terminated |
NCT00179933 -
The Impact of Implementing NIDCAP on Preterm Infants in the NICU
|
N/A | |
Completed |
NCT00114543 -
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
|
Phase 3 | |
Terminated |
NCT05030012 -
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
|
N/A | |
Completed |
NCT00552383 -
The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care
|
N/A | |
Completed |
NCT00011362 -
Dexamethasone Therapy in VLBW Infants at Risk of CLD
|
Phase 3 | |
Completed |
NCT06308471 -
Effect of Baby Massage on Oral Motor Skills of Premature Babies
|
N/A | |
Completed |
NCT01863043 -
Aspiration of Residual Gastric Contents
|
N/A | |
Completed |
NCT05462509 -
Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda
|
N/A | |
Not yet recruiting |
NCT06109350 -
The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants
|
N/A | |
Completed |
NCT03551600 -
Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
|
||
Terminated |
NCT02599545 -
Testosterone and Cortisol Levels in Infants
|
||
Completed |
NCT02611284 -
Less Invasive Beractant Administration in Preterm Infants
|
N/A | |
Completed |
NCT01193270 -
Vitamin E for Extremely Preterm Infants
|
Phase 1 | |
Withdrawn |
NCT00536445 -
Use of NAVA in Intubated Preterm
|
Phase 1/Phase 2 | |
Completed |
NCT00455169 -
Influenza Vaccine in Premature Infants
|
Phase 4 | |
Completed |
NCT00579553 -
Comparing IM vs. Vaginal Progesterone for Pre-term Birth
|
N/A | |
Completed |
NCT01203423 -
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
|