Clinical trial NCT04836208: Neonatal Acquisition of ESBL-PE in a Low-income Country - NeoLIC
Official title: Neonatal Acquisition of ESBL-PE in a Low-income Country
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Enterobacteriaceae Infections
Keywords: new born
intra-domiciliary transmission
community
Madagascar
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut Pasteur de Madagascar
name: Centre hospitalier de référence du District de Moramanga
First posted: 2021-04-08
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. epidemiological study

   All members of 60 households in which a newborn baby has just been born
2. anthropological study with interviews

16 homes will be selected from among the 60 homes included: 8 homes (no ESBL-E) and 8 homes (ESBL-E). Interviews will be carried out with: 16 mothers 4 people with a mothering role on the child 4 minors in the families 4 fathers

Also, interviews will be done with:

Health actors: medical and traditional, 1 community health worker

1 neighborhood chief

3) anthropological study with observations 4 households in total among the 16 initially selected for the interviews: 2 households (no ESBL-E) and 2 households (ESBL-E)

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.

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

Primary outcomes:
measure: Number of acquisition events and the number of non-acquisition of E-ESBL in newborns for the epidemiological part
timeFrame: 2 years
measure: Number of semi-structured interviews completed for the anthropological part
timeFrame: 2 years
measure: Number of participant direct observation completed for the anthropological part
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Antananarivo
country: Madagascar
facility: Institut Pasteur de Madagascar
Study officials:
affiliation: Institut Pasteur
name: Bich-Tram Huynh
role: STUDY_DIRECTOR
References: