Neonatal Acquisition of ESBL-PE in a Low-income Country - NeoLIC
- Conditions
- Enterobacteriaceae Infections
- Registration Number
- NCT04836208
- Lead Sponsor
- Institut Pasteur
- 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.
- 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:
* recruit a cohort of all members of 60 households in which a newborn has just been born
* carry out semi-structured interviews and direct participant observation.
This study is divided in two parts :
* 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.
* 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
-
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
- residing regularly in the study area OR planning to reside in the study area during the study period;
- having been informed of the research and collection of biological samples on herself and her newborn;
- having given its agreement to carry out the research and the associated collection of biological samples, and;
- having signed the informed consent (or its witness if applicable).
Inclusion criteria for the live newborn at the time of childbirth, new born :
- living after childbirth;
- whose parents or legal representatives present:
- reside regularly in the study area or plan to reside in the study area during the study period;
- were informed of the research and the associated collection of biological samples on their newborn;
- have given their agreement to carry out the research and the associated collection of biological samples,
Inclusion criteria for the household member, resident:
- from the same household as the mother-child (ren) couple included
- Residing at least 4 nights per week in this home
- Having given its agreement to carry out the research and the associated collection of biological samples,
- 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 :
- people responding to the structuring functions of the child's social and family environment
- Having given its agreement to carry out the research,
- 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 :
- people responding to the targeted functions
- working in the district of homes included
- Having given its agreement to carry out the research,
- 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
- Residents of the same household as the mother-child (ren) couple included
- having agreed to participate in the study
- Having given its agreement to carry out the research,
- and having signed the consent of the study (or its witness, or its legal representative if applicable)
-
For the epidemiological part:
- Pregnant woman: non-monofetal pregnancy
- Newborn: died during childbirth
- Household resident: None
-
and 3) For the anthropological part: • Semi-structured interview:
For household members:
-
not responding to the structural family and social functions of the child's environment For health workers and district managers
-
people not meeting the targeted functions
-
not practicing in the district of homes included
• Participant direct observation:
-
Not living in the same household as the mother-child couple included
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut Pasteur de Madagascar
🇲🇬Antananarivo, Madagascar