Design of a Non-invasive Multi-modal Neonatal Monitoring System

NCT03270410 | Completed

• 1 other identifier: 35RC15_3012
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Disorder

Keywords

neonates; non invasive monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 2 months

Secondary Outcomes (2)

• Evolution of the respiratory variability during the stay in the ward

  Up to 2 months

• Evolution of the babies' movements during the stay in the ward

  Up to 2 months

Study Arms (1)

Neonates

Babies born in Rennes University Hospital

Other: Data collection

Interventions

Data collection OTHER

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.

Neonates

Eligibility Criteria

• Age: Up to 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This study is aimed at newborns hospitalized at the CHU in Rennes

You may qualify if:

• 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.

You may not qualify if:

• Congenital malformation;
• Metabolic disease.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Patrick PLADYS, MD, PhD

  CHU Rennes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: September 1, 2017
• Study Start: September 17, 2015
• Primary Completion: October 26, 2016
• Study Completion: October 26, 2016
• Last Updated: October 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)