Immune Dysfunction in Newborn Sepsis

NCT03780712 | Completed DMC

• 1 other identifier: RECIPAL
• Study Type: observational
• Target: 585
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sepsis Newborn; Malaria; Immune Responses

Outcome Measures

Primary Outcomes (1)

• Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic

  To measure in cord blood the association and performance of PCT and the early diagnosis of neonatal sepsis for infants at risk to develop infection

  At birth

Secondary Outcomes (4)

• Evaluate Procalcitonin (PCT) for late onset neonatal sepsis diagnostic

  At one week after birth

• To draw Procalcitonin (PCT) expression profile during 12 weeks after birth

  Twelve weeks follow-up after birth

• Evaluate 2 host biomarkers mRNA expression (CD74 and CX3CR1) to prognostic neonatal sepsis

  Twelve weeks follow-up after birth

• FilmArray panels for early diagnosis of neonatal sepsis

  Twelve weeks follow-up after birth

Study Arms (1)

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

Other: Non applicable

Interventions

Non applicable OTHER

No intervention as it is an observational study

Sepsis Risk Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioMérieux: lead
• Institut de Recherche pour le Developpement: collaborator
• Centre National de la Recherche Scientifique, France: collaborator
• IRCB (Institut de la Recherche Clinique du Bénin): collaborator

Related Publications (2)

• 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.

  PMID: 36509812 DERIVED

• 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.

  PMID: 32709653 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood heparin tube Whole blood PAXgene Whole blood EDTA Dry Blood Spot Faeces Ficoll processed mononuclear cells Plasma

MeSH Terms

Conditions

Neonatal Sepsis; Malaria

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

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

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: December 19, 2018
• Study Start: April 17, 2016
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12