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Clostridium and Neonatal Necrotizing Enterocolitis Pathophysiology : Clinical and Molecular Approaches

NCT02444624 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2021-09-13

No results posted yet for this study

Summary

The clinical study involves a French network of 20 neonatology centres created as part of the EPIFLORE project. Investigators propose including all premature babies with confirmed necrotizing enterocolitis (NEC) diagnosis (Bell stage II or III) paired with a control group of healthy premature babies, over a 2-year period. The clinical data will be entered at inclusion until departure from the department, and the ASQ (Ages and Stages Questionnaires) will be collected after 24 months. Samples from NEC cases and from the control group will be submitted for microbiological testing by culture and pyrosequencing. This will enable the main aerobic micro-organisms in the dominant and subdominant intestinal microbiota to be isolated. This case-control study will be used to compile a collection of clinical and microbiological data, in order to confirm the role of bacteria in the pathophysiology of NEC, and to confirm the involvement of bacteria from the Clostridium genus in particular.

Conditions

  • Necrotizing Enterocolitis

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Jean-Christophe Roze, Pr · Nantes University Hospital

Eligibility

Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-28
Primary Completion
2019-09-13
Completion
2019-09-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02444624 on ClinicalTrials.gov