An interventional study of premature newborns developing a NEC and premature newborns without NEC in Necrotizing Enterocolitis and Premature Birth, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 1 Minute to 2 Minutes. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Other
Compare the bacterial digestive microbiota during the stay in neonatal intensive care between a group of premature newborns developing a NEC (necrotizing enterocolitis) and a group of newborns free from NEC.
Monitoring of a cohort of premature newborns with constitution of a collection of biological samples.
follow-up of newborns from birth up to 37 weeks of amenorrhea. The medical care of children will not be affected by their participation in the research.
Record of all complications related to prematurity (HIV, bronchodysplastic, sepsis)
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's enrollment of 297 is above the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
premature newborns developing a NEC
Biological: premature newborns developing a NEC
premature newborns without NEC
Biological: premature newborns without NEC
weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC
weekly Blood sample and daily Stools sample during 12 weeks
comparison of volatolomics results of the gut microbiota
Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA
Time frame: Immediatly after the intervention
comparison of microbiological results of the gut microbiota
Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA
Time frame: Immediatly after the intervention
Fungal microbiota
Comparison of the fungal microbiota on 10 NECS and 10 healthy babies
Time frame: Immediatly after the intervention
Tryptasemia
measurement of blood tryptasemia
Time frame: Day 1, Day 3, Immediatly after the intervention
environmental xenobiotics
measurement of titane and silicia levels in placental and meconium assays
Time frame: Day 1
Milk protein composition
milk protein determination
Time frame: daily for 12 weekd
Milk lipid composition
milk lipid determination
Time frame: daily for 12 weekd
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2021 to primary completion in Aug 2024, 36 months.
Of 33 interventional studies with no phase under Enterocolitis, Necrotizing, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 59. This study's 36 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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