Clostridium and Neonatal Necrotizing Enterocolitis Pathophysiology : Clinical and Molecular Approaches

NCT02444624 | Completed

• 1 other identifier: RC14_0295
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

necrotizing enterocolitis; Clostridium; premature birth

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the difference in prevalence of colonisation by bacteria from the Clostridium genus between the two study groups, CASE and CONTROL.

  Results from analyses will not be used back for patients enrolled in this non interventional study

  Inclusion until departure from hospital, an average of three months

Secondary Outcomes (1)

• Phenotypic comparison of clostridia between the 2 CASE and CONTROL groups

  Inclusion until departure from hospital, an average of three months

Study Arms (2)

not necrotizing enterocolitis group

not necrotizing enterocolitis preterm neonates matched with necrotizing enterocolitis preterm neonates

necrotizing enterocolitis group

necrotizing enterocolitis preterm neonates of gestational age less than or equal to 31+6 weeks of amenorrhoea with confirmed NEC diagnosis (Bell stage II or III)

Eligibility Criteria

• Age: Up to 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment of CASES (NEC group) will prospectively occure according to the following schedule: Following the diagnosis confirmed ECUN (stage II or III Bell) during the stay in neonatology: * stool sample at the earliest * In case of surgery, if resection: a collection of intestinal contents and biopsy of the intestinal mucosa during the act * collection of clinical data from birth until hospital discharge or transfer of the child and then collecting the ASQ 24 months. Inclusion of control patients should be made within 7 days of the onset of the corresponding NEC case. Informed parents will previously allow enrollment of their child to set faeces sampling and data capture from birth to the output of hospitalization or transfer of the child and then collecting the ASQ 24 months.

You may qualify if:

• Newborn gestational age less than or equal to 31 + 6 weeks of amenorrhea
• ECUN of diagnosis (Stage II or III Bell) confirmed
• Parental non-opposition / legal representative
• Newborn gestational age less than or equal to 31 + 6 weeks of amenorrhea
• Respect for matching the order of priority set for criteria
• of 2 control patients will be free of any antibiotic
• Parental non-opposition / legal representative

Sponsors & Collaborators

• Nantes University Hospital: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Nantes UH

Nantes, 44000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal samples

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jean-Christophe Roze, Pr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: May 14, 2015
• Study Start: May 28, 2015
• Primary Completion: September 13, 2019
• Study Completion: September 13, 2019
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

FR (1)