Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns (DAIR3N)
|ClinicalTrials.gov Identifier: NCT02434679|
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : October 24, 2019
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||278 participants|
|Official Title:||Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||March 2016|
- The occurrence over time of digestive acquisition of any type of RI [ Time Frame: 3 weeks ]
- The occurrence over time of digestive acquisition of severals type of RI [ Time Frame: 3 weeks ]"intI1" whenever the gene encoding a class 1 integrase will be detected "intI2" whenever the gene encoding a class 2 integrase will be detected "intI3" whenever the gene encoding a class 3 integrase will be detected An association: "intI1+intI2", "intI1+intI3", "intI2+intI3", "intI1+intI2+intI3" will also be searched.
- Occurrence over time of digestive acquisition of MRB in NB hospitalized in neonatology units [ Time Frame: 3 weeks ]Occurrence over time of digestive acquisition of MRB in NB hospitalized in neonatology units
Biospecimen Retention: Samples With DNA
The meconium or the first stool will be sampled at D0. The stool will then be sampled: at D7, at D21 and every 15 days until the day of discharge.
If the NB has no stool on the given day, a period of 3 more days will be accepted from the day the sampling was planned. After this period, "no sample" will be stated.
Meconiums and stool must be sampled in sterile jars, labelled and sent with the designation "DAIR3N protocol" to the bacteriology laboratory of each center. If the local laboratory cannot seed the samples 7 days a week, stool samples can be kept maximum 48h at +4°C before management.
In the mother
Vaginal sample will be taken during the delivery according to care practices of each center if:
it is a preterm vaginal delivery, early membrane rupture happens, there is a threat of very preterm delivery. About 55% of inclusions should be subject to this type of sampling. Sampling of mother's stool will be asked at the inclusion.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434679
|Bayonne, France, 64109|
|Bordeaux, France, 33076|
|Limoges, France, 87042|
|Pau, France, 64000|
|Toulouse, France, 31059|
|Principal Investigator:||Antoine BEDU, MD||University Hospital, Limoges|