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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)

This study is currently recruiting participants.
Verified April 2016 by Centre Hospitalier Universitaire, Amiens
Sponsor:
ClinicalTrials.gov Identifier:
NCT03117907
First Posted: April 18, 2017
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
  Purpose

Despite advances in medicine, secondary neonatal infection remains a continuing concern because of the associated high morbidity and mortality. The usual mechanism of infection responds to the transmission of germs by the equipment used for care (eg, catheters) and by the hands of caregivers. In preterm infants in particular, some infections can also have an endogenous source, by translocation of colonization germs present in the digestive tract.

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.


Condition
Newborn Infection

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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)

Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Measurement of the mean value of the perfusion index (PI) measured on the right hand [ Time Frame: 3 days ]

Estimated Enrollment: 30
Actual Study Start Date: March 24, 2016
Estimated Study Completion Date: March 24, 2018
Estimated Primary Completion Date: March 24, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Infants with low infectious status
Infants with high infectious status

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   27 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newborn of corrected age between 27 SA and 42 SA with at least 72 hours of postnatal age
Criteria

Inclusion Criteria:

  • Newborn of corrected age between 27 SA and 42 SA with at least 72 hours of postnatal age
  • 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:

  • Congenital malformation neurological, cardiac, respiratory, vascular and cutaneous.
  • A proven episode of materno-fetal infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117907


Contacts
Contact: Sabrina GOUDJIL, Dr +33322087605 goudjil.sabrina@chu-amiens.fr

Locations
France
CHU Amiens Picardie Recruiting
Amiens, Picardie, France, 80054
Contact: Sabrina GOUDJIL, Dr    +33322087605    goudjil.sabrina@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
  More Information

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03117907     History of Changes
Other Study ID Numbers: RNI01-2016
First Submitted: April 13, 2017
First Posted: April 18, 2017
Last Update Posted: April 18, 2017
Last Verified: April 2016