Neonatal Acquisition of ESBL-PE in a Low-income Country - NeoLIC

Launched by INSTITUT PASTEUR · Apr 5, 2021

Keywords

ClinConnect Summary

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 anthropologi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. 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)
• • 2. 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)
• • 3. 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 Criteria:
• 1. For the epidemiological part:
• • Pregnant woman: non-monofetal pregnancy
• • Newborn: died during childbirth
• • Household resident: None
• 2. 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