Status:
UNKNOWN
Neonatal Acquisition of ESBL-PE in a Low-income Country - NeoLIC
Lead Sponsor:
Institut Pasteur
Collaborating Sponsors:
Institut Pasteur de Madagascar
Centre hospitalier de référence du District de Moramanga
Conditions:
Enterobacteriaceae Infections
Eligibility:
All Genders
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 multidru...
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 hous...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04836208
Start Date
April 30 2021
End Date
May 1 2023
Last Update
October 7 2022
Active Locations (1)
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1
Institut Pasteur de Madagascar
Antananarivo, Madagascar