Status:
COMPLETED
Immune Dysfunction in Newborn Sepsis
Lead Sponsor:
BioMérieux
Collaborating Sponsors:
Institut de Recherche pour le Developpement
Centre National de la Recherche Scientifique, France
Conditions:
Sepsis Newborn
Malaria
Eligibility:
All Genders
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for the sepsis risk group (400 infants):
- 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.
- Inclusion Criteria for the control group (170 infants):
- \- Child born from mothers enrolled in the RECIPAL study (Pregnancy-associated malaria and Intrauterine growth restriction in Benin)
- Exclusion Criteria for both groups:
- 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.
Exclusion
Key Trial Info
Start Date :
April 17 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 12 2018
Estimated Enrollment :
585 Patients enrolled
Trial Details
Trial ID
NCT03780712
Start Date
April 17 2016
End Date
March 12 2018
Last Update
December 19 2018
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