Comparison of Peripheral Perfusion Level Between Two Groups of Newborns According to Their Infectious Status Defined by the Criteria of the Center for Disease Control and Prevention (CDC)
NCT ID: NCT03117907
Last Updated: 2017-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
30 participants
OBSERVATIONAL
2016-03-24
2018-03-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The first line of prevention of secondary infection corresponds to compliance with the rules of hand hygiene, work surfaces and equipment carried out, the effect of which on the control of the incidence of secondary infection is regularly demonstrated. When declared, bacterial infection should be treated as quickly as possible with appropriate and effective antibiotics to preserve the healing prognosis. Compared to the infant and the larger child, clinical signs of calling are atypical and discrete. In the absence of staff trained to monitor newborns specifically, there is a real risk of discovering the existence of the infection only at an advanced stage corresponding, among other things, to circulatory collapse. This risk is not completely excluded, even with experienced practitioners, because the positive signs are rude and may go unnoticed (eg, signs of calling such as fever are rare in the newborn). Support for early diagnosis of neonatal infection by automatic monitoring systems has reduced mortality by 30% in the units where it has been applied. This is probably due to the fact that early warning made it possible to start the antibiotic treatment earlier and to complete the bacteriological diagnosis in order to better orient the therapeutic attitude. The best criteria for early diagnosis by automated systems were provided by the statistical analysis of cardiac variability, the results of the research and correspond to the standard deviation, the asymmetry and the entropy of the series d Cardiac intervals. Since microbial aggression has an impact on many vegetative variables outside of the electrocardiogram, our current research aims to determine whether the analysis of the perfusion index (PI) Which are of interest for detecting disturbances in the early stages of infection in newborns. IP corresponds to the ratio of the amplitude of the oscillating phase to the intensity of the constant part of the opto-plethysmography wave; It is obtained from signals recorded in a non-invasive manner by the same infrared sensor for pulse oximetry.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hospitalizations in Neonatal Period and Early Discharge of Maternity
NCT05550272
Peripherel Perfusion Index to Predict Sepsis in Very Low Birth Weight Infants
NCT05224921
Defining the Intestinal Microbiota in Premature Neonates
NCT01102738
Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis
NCT03623503
Neonatal Sepsis Diagnosis: ; PCR Commercial Technique and Blood Culture
NCT03884894
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Infants with low infectious status
No interventions assigned to this group
Infants with high infectious status
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Presence of clinical or biological criteria of infection according to CDC definitions
* Absence of clinical or biological criteria for infection according to CDC definitions
Exclusion Criteria
* A proven episode of materno-fetal infection
27 Weeks
42 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire, Amiens
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Amiens Picardie
Amiens, Picardie, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RNI01-2016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.