<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03780712</url>
  </required_header>
  <id_info>
    <org_study_id>RECIPAL</org_study_id>
    <nct_id>NCT03780712</nct_id>
  </id_info>
  <brief_title>Immune Dysfunction in Newborn Sepsis</brief_title>
  <acronym>RECIPAL</acronym>
  <official_title>Neonatal Immune Dysfunction Associated to the Risk of Newborn Sepsis in Benin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioMérieux</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut de Recherche pour le Developpement</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre National de la Recherche Scientifique, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IRCB (Institut de la Recherche Clinique du Bénin)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>BioMérieux</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the project is to study neonatal immune dysfunction associated to the risk of&#xD;
      newborn sepsis in a malaria endemic area in Benin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The fetal immunological responses maturate gradually during the last 3 months of pregnancy.&#xD;
      To respond to pathogens, newborns depend essentially on their innate immune system. Premature&#xD;
      babies have a significant impairment of innate and immune regulatory functions, thus&#xD;
      promoting neonatal sepsis. In addition, chronic infections during pregnancy, including those&#xD;
      of parasitic origin, fetal immunity. In utero exposure to P. falciparum antigens impacts&#xD;
      particularly the newborn immune development and is a risk factor predisposing to malaria and&#xD;
      also to other infections during the first year of life.&#xD;
&#xD;
      The major objectives are to assess:&#xD;
&#xD;
        -  The relevance of a host biomarker driven diagnostic of sepsis in newborns,&#xD;
&#xD;
        -  The relevance of immune markers as indicators of sepsis incidence, secondary infections&#xD;
           occurrence, and mortality&#xD;
&#xD;
        -  The role of novel diagnostic techniques (FilmArray panels) as part of the&#xD;
           microbiological diagnostic,&#xD;
&#xD;
        -  The immunological profile of the infants in the 3 first months of life.&#xD;
&#xD;
      The targeted population is newborns with a high risk to develop sepsis recruited at delivery&#xD;
      compared to a control infant population with a low infection risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2016</start_date>
  <completion_date type="Actual">March 12, 2018</completion_date>
  <primary_completion_date type="Actual">March 12, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic</measure>
    <time_frame>At birth</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate Procalcitonin (PCT) for late onset neonatal sepsis diagnostic</measure>
    <time_frame>At one week after birth</time_frame>
    <description>To measure in peripheral blood the association and performance of PCT and the diagnosis of late onset neonatal sepsis for infants at risk to develop infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To draw Procalcitonin (PCT) expression profile during 12 weeks after birth</measure>
    <time_frame>Twelve weeks follow-up after birth</time_frame>
    <description>To measure PCT concentration during 12 weeks (sampling at birth, week 1, week 4, week 8 and week 12) and explore the relevance of host biomarker-driven antibiotherapy in a low-income country</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate 2 host biomarkers mRNA expression (CD74 and CX3CR1) to prognostic neonatal sepsis</measure>
    <time_frame>Twelve weeks follow-up after birth</time_frame>
    <description>To measure CD74 and CX3CR1 mRNA expression in order to evaluate their performance on the early prognostic of neonatal sepsis for infants at risk to develop infections (occurrence of secondary infections and mortality rate)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FilmArray panels for early diagnosis of neonatal sepsis</measure>
    <time_frame>Twelve weeks follow-up after birth</time_frame>
    <description>To test commercial FilmArray panels in order to evaluate the role of novel diagnostic techniques as part of the diagnostic algorithm on the early diagnosis of neonatal sepsis over a period of 12 weeks for infants at risk to develop infection</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">585</enrollment>
  <condition>Sepsis Newborn</condition>
  <condition>Malaria</condition>
  <condition>Immune Responses</condition>
  <arm_group>
    <arm_group_label>Sepsis Risk Group</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non applicable</intervention_name>
    <description>No intervention as it is an observational study</description>
    <arm_group_label>Sepsis Risk Group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood heparin tube Whole blood PAXgene Whole blood EDTA Dry Blood Spot Faeces Ficoll&#xD;
      processed mononuclear cells Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The targeted population is newborns with a high risk to develop sepsis recruited at&#xD;
        delivery compared to a control infant population with a low infection risk.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for the sepsis risk group (400 infants):&#xD;
&#xD;
          -  Child born from mothers having one of the following criteria before delivery will be&#xD;
             included in this study:&#xD;
&#xD;
               -  Spontaneous preterm delivery (&lt;37 weeks of gestation time)&#xD;
&#xD;
               -  Foul smelling / with meconium / colored / bloody amniotic liquid&#xD;
&#xD;
               -  Rupture of membranes &gt; 18 hours&#xD;
&#xD;
               -  Maternal fever at delivery&#xD;
&#xD;
               -  Vaginal infection&#xD;
&#xD;
          -  Child born at the maternity of CNHU (Centre National Hospitalier et Universitaire,&#xD;
             Cotonou, Benin) or CHUMEL (Centre Hospitalier et Universitaire de la Mère et de&#xD;
             l'Enfant Lagune, Cotonou, Benin) or HZAC (Hopital de zone d' Abomey-Calavi, Benin).&#xD;
&#xD;
          -  Mother located near Abomey-Calavi. This criterion has been included to limit the&#xD;
             follow-up expenses and spare the travel to the project staff in charge of the 3 month&#xD;
             follow-up.&#xD;
&#xD;
        Inclusion Criteria for the control group (170 infants):&#xD;
&#xD;
        - Child born from mothers enrolled in the RECIPAL study (Pregnancy-associated malaria and&#xD;
        Intrauterine growth restriction in Benin)&#xD;
&#xD;
        Exclusion Criteria for both groups:&#xD;
&#xD;
          -  HIV + status or unknown HIV status of the mother (as the mother and child will be part&#xD;
             of the national program to take care of mother and child HIV+ at delivery)&#xD;
&#xD;
          -  Parents do not consent to be included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>March 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
    <mesh_term>Neonatal Sepsis</mesh_term>
    <mesh_term>Immune System Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03780712
org study id: RECIPAL
nct id: NCT03780712
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic
time frame: At birth
description: 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
measure: Evaluate Procalcitonin (PCT) for late onset neonatal sepsis diagnostic
time frame: At one week after birth
description: To measure in peripheral blood the association and performance of PCT and the diagnosis of late onset neonatal sepsis for infants at risk to develop infection
measure: To draw Procalcitonin (PCT) expression profile during 12 weeks after birth
time frame: Twelve weeks follow-up after birth
description: To measure PCT concentration during 12 weeks (sampling at birth, week 1, week 4, week 8 and week 12) and explore the relevance of host biomarker-driven antibiotherapy in a low-income country
measure: Evaluate 2 host biomarkers mRNA expression (CD74 and CX3CR1) to prognostic neonatal sepsis
time frame: Twelve weeks follow-up after birth
description: To measure CD74 and CX3CR1 mRNA expression in order to evaluate their performance on the early prognostic of neonatal sepsis for infants at risk to develop infections (occurrence of secondary infections and mortality rate)
measure: FilmArray panels for early diagnosis of neonatal sepsis
time frame: Twelve weeks follow-up after birth
description: To test commercial FilmArray panels in order to evaluate the role of novel diagnostic techniques as part of the diagnostic algorithm on the early diagnosis of neonatal sepsis over a period of 12 weeks for infants at risk to develop infection
arm group label: Sepsis Risk Group
description: 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
intervention type: Other
intervention name: Non applicable
description: No intervention as it is an observational study
arm group label: Sepsis Risk Group
Whole blood heparin tube Whole blood PAXgene Whole blood EDTA Dry Blood Spot Faeces Ficoll
      processed mononuclear cells Plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Toxemia
mesh term: Neonatal Sepsis
mesh term: Immune System Diseases