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Immune Dysfunction in Newborn Sepsis

NCT ID: NCT03780712

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

585 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-17

Study Completion Date

2018-03-12

Brief Summary

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The aim of the project is to study neonatal immune dysfunction associated to the risk of newborn sepsis in a malaria endemic area in Benin.

Detailed Description

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The fetal immunological responses maturate gradually during the last 3 months of pregnancy. To respond to pathogens, newborns depend essentially on their innate immune system. Premature babies have a significant impairment of innate and immune regulatory functions, thus promoting neonatal sepsis. In addition, chronic infections during pregnancy, including those of parasitic origin, fetal immunity. In utero exposure to P. falciparum antigens impacts particularly the newborn immune development and is a risk factor predisposing to malaria and also to other infections during the first year of life.

The major objectives are to assess:

* The relevance of a host biomarker driven diagnostic of sepsis in newborns,
* The relevance of immune markers as indicators of sepsis incidence, secondary infections occurrence, and mortality
* The role of novel diagnostic techniques (FilmArray panels) as part of the microbiological diagnostic,
* The immunological profile of the infants in the 3 first months of life.

The targeted population is newborns with a high risk to develop sepsis recruited at delivery compared to a control infant population with a low infection risk.

Conditions

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Sepsis Newborn Malaria Immune Responses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sepsis Risk Group

419 infants born from mothers at risk to deliver babies with neonatal infections in Cotonou hospitals (Benin) 166 infants without sepsis born from mothers enrolled in a study to monitor pregnancy-associated malaria and Intrauterine growth restriction in Benin

Non applicable

Intervention Type OTHER

No intervention as it is an observational study

Interventions

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Non applicable

No intervention as it is an observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Child born from mothers having one of the following criteria before delivery will be included in this study:

* Spontaneous preterm delivery (\<37 weeks of gestation time)
* Foul smelling / with meconium / colored / bloody amniotic liquid
* Rupture of membranes \> 18 hours
* Maternal fever at delivery
* Vaginal infection
* Child born at the maternity of CNHU (Centre National Hospitalier et Universitaire, Cotonou, Benin) or CHUMEL (Centre Hospitalier et Universitaire de la Mère et de l'Enfant Lagune, Cotonou, Benin) or HZAC (Hopital de zone d' Abomey-Calavi, Benin).
* Mother located near Abomey-Calavi. This criterion has been included to limit the follow-up expenses and spare the travel to the project staff in charge of the 3 month follow-up.


\- Child born from mothers enrolled in the RECIPAL study (Pregnancy-associated malaria and Intrauterine growth restriction in Benin)

Exclusion Criteria

* HIV + status or unknown HIV status of the mother (as the mother and child will be part of the national program to take care of mother and child HIV+ at delivery)
* Parents do not consent to be included in the study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

IRCB (Institut de la Recherche Clinique du Bénin)

UNKNOWN

Sponsor Role collaborator

BioMérieux

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Ezinmegnon S, Mommert M, Bartolo F, Agbota G, Darius S, Briand V, d'Almeida M, Alao MJ, Dossou-Dagba I, Massougbodji A, Lausten-Thomsen U, Pachot A, Vachot L, Yugueros-Marcos J, Brengel-Pesce K, Fievet N, Tissieres P. Prospective multicentre study of host response signatures in neonatal sepsis in Sub Saharan Africa. Sci Rep. 2022 Dec 12;12(1):21458. doi: 10.1038/s41598-022-25892-x.

Reference Type DERIVED
PMID: 36509812 (View on PubMed)

Fievet N, Ezinmegnon S, Agbota G, Sossou D, Ladekpo R, Gbedande K, Briand V, Cottrell G, Vachot L, Yugueros Marcos J, Pachot A, Textoris J, Blein S, Lausten-Thomsen U, Massougbodji A, Bagnan L, Tchiakpe N, d'Almeida M, Alao J, Dossou-Dagba I, Tissieres P; SEPSIS study group collaborators; SEPSIS study group. SEPSIS project: a protocol for studying biomarkers of neonatal sepsis and immune responses of infants in a malaria-endemic region. BMJ Open. 2020 Jul 23;10(7):e036905. doi: 10.1136/bmjopen-2020-036905.

Reference Type DERIVED
PMID: 32709653 (View on PubMed)

Other Identifiers

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RECIPAL

Identifier Type: -

Identifier Source: org_study_id