Neonatal Acquisition of ESBL-PE in a Low-income Country - NeoLIC
Study Details
Study Description
Brief Summary
Enterobacteriaceae, more specifically Escherichia coli and Klebsiella pneumoniae, are the bacteria most often responsible for neonatal infections in low-income countries. Infections caused by multidrug-resistant Enterobacteriaceae: Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E), are more often associated with an unfavorable outcome of the infection.
Enterobacteriaceae colonize the digestive tract which is the first step in developing a potential infection. Very few studies have been carried out at the community level. Colonization of the mother with ESBL-E is generally considered to be a major route of acquisition. The carrying of ESBL-E by other family members and other potential sources of transmission (food, objects and surfaces in contact with the newborn) have never been documented.
In addition, with a view to offering an intervention adapted to the local context, the local cultural determinants which govern the interactions of the newborn with his environment are important to understand.
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Detailed Description
This is a single-center prospective cohort of all members living in the same household in which a newborn baby has just been born.
The study consists to:
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recruit a cohort of all members of 60 households in which a newborn has just been born
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carry out semi-structured interviews and direct participant observation.
This study is divided in two parts :
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the epidemiological part : the documentation of colonization by E-ESBL by sampling the stools of the newborn, of all members of the household, and sampling of food given to the child, from surfaces in contact with it.
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the anthropological part : Semi-structured interviews with key people in the structuring of the social and family environment of the newborn and participant direct observation of households.
Study Design
Outcome Measures
Primary Outcome Measures
- Number of acquisition events and the number of non-acquisition of E-ESBL in newborns for the epidemiological part [2 years]
Identification of bacterial strains from stool and sequencing of EBSL-E strains
- Number of semi-structured interviews completed for the anthropological part [2 years]
1 or 4 hours semi-structured interviews of participants at home done by investigators
- Number of participant direct observation completed for the anthropological part [2 years]
observations of the participants at home done by investigators (2 to 4 hours in 3 to 4 sessions over 28 days)
Eligibility Criteria
Criteria
Inclusion Criteria:
- For the epidemiological study :
All members of 60 households in which a newborn baby has just been born
Inclusion criteria for the mother at the time of childbirth, pregnant woman :
_ having a monofetal pregnancy
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residing regularly in the study area OR planning to reside in the study area during the study period;
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having been informed of the research and collection of biological samples on herself and her newborn;
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having given its agreement to carry out the research and the associated collection of biological samples, and;
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having signed the informed consent (or its witness if applicable).
Inclusion criteria for the live newborn at the time of childbirth, new born :
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living after childbirth;
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whose parents or legal representatives present:
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reside regularly in the study area or plan to reside in the study area during the study period;
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were informed of the research and the associated collection of biological samples on their newborn;
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have given their agreement to carry out the research and the associated collection of biological samples,
Inclusion criteria for the household member, resident:
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from the same household as the mother-child (ren) couple included
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Residing at least 4 nights per week in this home
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Having given its agreement to carry out the research and the associated collection of biological samples,
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and having signed the consent of the study (or its witness, or its legal representative if applicable)
- for the anthropological study with interviews : 16 homes will be selected from among the 60 homes included: 8 homes in which the child has not acquired an ESBL-E during the entire follow-up and 8 homes in which the child has acquired an ESBL-E at least once during its follow-up. Among these households, interviews will be carried out with: 16 mothers or first responsible for the child in the absence of the mother 4 people with a mothering role on the child (grandmother, aunts ...) 4 minors in the families to observe 4 fathers or father figures in families to observe
Also, interviews will be done with:
Health actors: medical (1 midwife and 1 neighborhood doctor) and traditional (1 matron and 1 traditional practitioner from the neighborhood), 1 community health worker 1 neighborhood chief
Inclusion criteria for semi-structured interviews :
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people responding to the structuring functions of the child's social and family environment
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Having given its agreement to carry out the research,
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and having signed the consent of the study (or its witness, or its legal representative if applicable)
For health workers and district managers, inclusion criteria for semi-structured interviews :
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people responding to the targeted functions
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working in the district of homes included
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Having given its agreement to carry out the research,
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and having signed the consent of the study (or its witness, or its legal representative if applicable)
- For the anthropological study with observations 4 households in total among the 16 initially selected for the interviews: 2 households in which the child did not acquire ESBL-E during all the follow-up and 2 households in which the child acquired at least once an BLSE-E during his follow-up Inclusion criteria for participating direct observations
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Residents of the same household as the mother-child (ren) couple included
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having agreed to participate in the study
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Having given its agreement to carry out the research,
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and having signed the consent of the study (or its witness, or its legal representative if applicable)
Exclusion Criteria:
- For the epidemiological part:
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Pregnant woman: non-monofetal pregnancy
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Newborn: died during childbirth
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Household resident: None
- and 3) For the anthropological part: • Semi-structured interview:
For household members:
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not responding to the structural family and social functions of the child's environment For health workers and district managers
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people not meeting the targeted functions
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not practicing in the district of homes included
• Participant direct observation:
- Not living in the same household as the mother-child couple included
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Pasteur de Madagascar | Antananarivo | Madagascar |
Sponsors and Collaborators
- Institut Pasteur
- Institut Pasteur de Madagascar
- Centre hospitalier de référence du District de Moramanga
Investigators
- Study Director: Bich-Tram Huynh, Institut Pasteur
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-059