Sepsis NewbornRECIPALNCT03780712
Immune Dysfunction in Newborn Sepsis
An observational study of Sepsis Newborn and Malaria, run by BioMérieux.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis Newborn, Malaria, Immune Responses
- What is being tested?
- Non applicable
- How many people
- 585 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2016to 12 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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.
About this study
Official title: Neonatal Immune Dysfunction Associated to the Risk of Newborn Sepsis in Benin
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.
Read the 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 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
- Sepsis Newborn, Malaria, Immune Responses
- Being tested
- Non applicable
- Medical subject headings
- Neonatal Sepsis, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non applicableOther
No intervention as it is an observational study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Non applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At birth
Secondary outcomes (4)
Evaluate Procalcitonin (PCT) for late onset neonatal sepsis diagnostic
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
Measured: At one week after birth
To draw Procalcitonin (PCT) expression profile during 12 weeks after birth
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
Measured: Twelve weeks follow-up after birth
Evaluate 2 host biomarkers mRNA expression (CD74 and CX3CR1) to prognostic neonatal sepsis
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)
Measured: Twelve weeks follow-up after birth
FilmArray panels for early diagnosis of neonatal sepsis
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
Measured: Twelve weeks follow-up after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start17 Apr 2016
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sepsis NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de Recherche pour le Developpement, Centre National de la Recherche Scientifique, France, Institut de Recherche Clinique du Benin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780712
- Sponsor's protocol ID
- RECIPAL
- Acronym
- RECIPAL
- Status last verified
- Dec 2018
- First submitted
- 13 Mar 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36509812Fievet 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.
PubMed 32709653
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Immune Dysfunction Associated to the Risk of Newborn Sepsis in Benin
- ClinicalTrials.gov ID
- NCT03780712
- Acronym / sponsor ID
- RECIPAL / RECIPAL
- Conditions
- Sepsis Newborn, Malaria, Immune Responses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Collaborators
- Institut de Recherche pour le Developpement, Centre National de la Recherche Scientifique, France, Institut de Recherche Clinique du Benin
- Study start
- 17 Apr 2016 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis Risk Group | – | Other: Non applicable419 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Child born from mothers having one of the following criteria before delivery will be included in this study:
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non applicableNo intervention as it is an observational study | Other | Sepsis Risk Group |
Primary outcome
Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic
Time frame: At birth
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
4 secondary outcomes
Evaluate Procalcitonin (PCT) for late onset neonatal sepsis diagnostic
Time frame: At one week after birth
To draw Procalcitonin (PCT) expression profile during 12 weeks after birth
Time frame: Twelve weeks follow-up after birth
Evaluate 2 host biomarkers mRNA expression (CD74 and CX3CR1) to prognostic neonatal sepsis
Time frame: Twelve weeks follow-up after birth
FilmArray panels for early diagnosis of neonatal sepsis
Time frame: Twelve weeks follow-up after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Derived from this study: PubMed 36509812Ezinmegnon 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.
- Derived from this study: PubMed 32709653Fievet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Newborn and Malaria, run by BioMérieux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03780712, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.