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Active, not recruitingNCT04584320ECUN-2Updated Nov 14, 2024

Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization

An observational study in Necrotizing Enterocolitis, sponsored by Centre Hospitalier Universitaire de Nīmes. Active, not recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2024-11-14.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Sex
All
01

Study summary

The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. Finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.

02

Conditions studied

  • Necrotizing Enterocolitis

Keywords

  • low-birth weight infant
  • Clostridium butyricum
  • Clostridium neonatale
03

In context

Enterocolitis, Necrotizing

228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.

This study's planned enrollment of 40 is below the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.

Browse Enterocolitis, Necrotizing studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Browse Centre Hospitalier Universitaire de Nīmes studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population consists of all newborns born less than 34 weeks of gestation admitted to the neonatology department of the CHU de Nîmes.

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.

Inclusion criteria

  • Premature newborn with a term of birth ≤ 34 weeks of gestation admitted to the neonatology department at the CHU of Nîmes.
  • Affiliated or beneficiary of a health insurance plan.
  • Newborn whose parents received informed information about the study and did not express their opposition to their child's participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Newborn with malformative digestive pathology
  • Newborn baby participating in another category 1 trial
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Premature neonates with necrotizing enterocolitis

    Other: Stool sample

  • Premature neonates without necrotizing enterocolitis

    Other: Stool sample

Interventions

  • OtherStool sample

    Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale

06

What researchers measure

Primary outcomes

  1. Presence of C. butyricum

    PCR

    Time frame: Each day of hospitalization (maximum 120 days)

  2. Presence of C. neonatale

    PCR

    Time frame: Each day of hospitalization (maximum 120 days)

  3. Culture of C. butyricum

    Growth on selective media

    Time frame: Each day of hospitalization (maximum 120 days)

  4. Culture of C. neonatale

    Growth on selective media

    Time frame: Each day of hospitalization (maximum 120 days)

Secondary outcomes

  1. Localisation within the hospital

    Bed numbers occupied

    Time frame: During hospitalization (maximum 120 days)

Other outcomes

  1. Age of mother

    Years

    Time frame: Day 0

  2. Body mass index of mother

    Kg/m2

    Time frame: Day 0

  3. Parity of mother

    Time frame: Day 0

  4. Gravidity of mother

    Time frame: Day 0

  5. Professional activity of mother

    Yes/no; description

    Time frame: Day 0

  6. Smoking status of mother

    Yes/no

    Time frame: Day 0

  7. Chronic pathology of mother

    Yes/no, description

    Time frame: Day 0

  8. Allergy of mother

    Yes/no, description

    Time frame: Day 0

  9. Number of years of schooling of mother

    Time frame: Day 0

  10. Exposure to magnesium sulfate during pregnancy

    Yes/no

    Time frame: Day 0

  11. Cause of prematurity

    Time frame: Day 0

  12. Method of delivery

    Vagina/Caesarean

    Time frame: Day 0

  13. Anesthesia during delivery

    General/spinal

    Time frame: Day 0

  14. Mode of delivery of vaginal birth

    Spontaneous/instrumental

    Time frame: Day 0

  15. Spontaneous rupture of membranes

    Yes/no

    Time frame: Day 0

  16. Time of rupture of membranes before birth

    \<12h/\>12h

    Time frame: Day 0

  17. Pathology during pregnancy

    Yes/No; description

    Time frame: Day 0

  18. Birth term

    Weeks and days

    Time frame: Day 0

  19. Birth weight

    grams

    Time frame: Day 0

  20. Birth weight percentile

    percentile

    Time frame: Day 0

  21. Birth height

    cm

    Time frame: Day 0

  22. Birth height ; percentile

    percentile

    Time frame: Day 0

  23. Intubation

    Yes/no

    Time frame: Day 0

  24. umbilical venous catheter

    Yes/no; duration

    Time frame: Day 0

  25. Epicutaneo-cava catheter

    Yes/no; duration

    Time frame: Day 0

  26. Daily lipid intake per os per kilp

    g/kg

    Time frame: During hospitlization (maximum 120 days)

  27. Presence of sequelae

    Yes/no

    Time frame: During hospitalization (maximum 120 days)

  28. Type of sequelae

    description

    Time frame: During hospitalization (maximum 120 days)

  29. Hemodynamically significant patent ductus arteriosus

    Yes/no

    Time frame: During hospitalization (maximum 120 days)

  30. Type of milk

    pasteurized/fresh/artificial

    Time frame: During hospitalization (maximum 120 days)

  31. Duration of milk intake

    Days

    Time frame: During hospitalization (maximum 120 days)

  32. Probiotic intake duration

    Days

    Time frame: During hospitalization (maximum 120 days)

  33. Types of probiotic taken

    Type

    Time frame: During hospitalization (maximum 120 days)

  34. Type of antibiotics taken in post-natal period

    Type

    Time frame: During hospitalization (maximum 120 days)

  35. Duration of antibiotic treatment in post-natal period

    Days

    Time frame: During hospitalization (maximum 120 days)

  36. Type of vasoactive amines taken

    Type

    Time frame: During hospitalization (maximum 120 days)

  37. Duration of vasoactive amine treatment

    Days

    Time frame: During hospitalization (maximum 120 days)

  38. Type of any postnatal surgery

    Type

    Time frame: During hospitalization (maximum 120 days)

  39. Total duration of parenteral feeding

    Days

    Time frame: During hospitalization (maximum 120 days)

  40. Ibuprofen

    Yes/no

    Time frame: During hospitalization (maximum 120 days)

  41. Hemodynamic shock

    Yes/no

    Time frame: During hospitalization (maximum 120 days)

  42. Labile Blood Product transfusion

    Amount

    Time frame: During hospitalization (maximum 120 days)

  43. antenatal corticosteroid therapy

    Complete/incomplete

    Time frame: Day 0

  44. Type of post-natal corticosteroid therapy

    Type

    Time frame: During hospitalization (maximum 120 days)

  45. Duration of post-natal corticosteroid therapy

    Days

    Time frame: During hospitalization (maximum 120 days)

  46. Exposure to ante- and post-natal antibiotics

    Description

    Time frame: During hospitalization (maximum 120 days)

  47. umbilical arterial catheter

    Duration

    Time frame: Day 0

  48. Nosocomial infection

    Proven/suspected

    Time frame: During hospitalization (maximum 120 days)

  49. Nosocomial infection infective agent

    name

    Time frame: During hospitalization (maximum 120 days)

  50. Rectal bleeding

    Number

    Time frame: During hospitalization (maximum 120 days)

  51. metabolic acidosis

    Yes/no

    Time frame: During hospitalization (maximum 120 days)

  52. Volume of alimentation per kilo

    Time frame: During hospitalization (maximum 120 days)

  53. Daily carbohydrate intake per os per kilp

    g/kg

    Time frame: During hospitalization (maximum 120 days)

  54. Daily proteins intake per os per kilp

    g/kg

    Time frame: During hospitalization (maximum 120 days)

  55. Volume of daily total alimentation

    Time frame: During hospitalization (maximum 120 days)

  56. Cranial circumference

    cm; percentile

    Time frame: Day 0

  57. Cranial circumference percentile

    percentile

    Time frame: Day 0

  58. Other catheter

    Type

    Time frame: Day 0

  59. Duration of other catheter

    Days

    Time frame: Day 0

  60. Enriched maternal milk

    Maximum percentage

    Time frame: During hospitalization (maximum 120 days)

  61. Milk thickening

    Duration

    Time frame: During hospitalization (maximum 120 days)

  62. Chorioamnionitis

    Proven/suspected

    Time frame: During hospitalization (maximum 120 days)

  63. Materno-fetal infection

    Proven/suspected

    Time frame: Day 0

  64. Materno-fetal infection infective agent

    name

    Time frame: Day 0

  65. pneumatosis-pneumoportia

    Yes/no

    Time frame: During hospitalization (maximum 120 days)

  66. Transfer

    Yes/no

    Time frame: During hospitalization (maximum 120 days)

  67. Time of occurence of ulcerative necrotizing enterocolitis

    weeks post-natal

    Time frame: During hospitalization (maximum 120 days)

  68. Warning signs of ulcerative necrotizing enterocolitis

    Time frame: During hospitalization (maximum 120 days)

  69. Duration of bowel rest following necrotizing enterocolitis

    Time frame: During hospitalization (maximum 120 days)

  70. Bell staging of ulcerative necrotizing enterocolitis

    from IA (suspected necrotizing enterocolitis) to IIIB (advanced necrotizing enterocolitis)

    Time frame: During hospitalization (maximum 120 days)

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2021 to primary completion in Nov 2024, 36 months.

Of 39 observational studies under Enterocolitis, Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 115. This study's 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2020
First posted
Oct 12, 2020
StartActual
Oct 18, 2021
Primary completionActual
Nov 9, 2024
CompletionEst.
Oct 2025
Last update
Nov 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04584320
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Oct 12, 2020
Start date
Oct 18, 2021
Primary completion
Nov 9, 2024
Completion
Oct 2025 (estimated)
Last update
Nov 14, 2024

Study contacts

Massimo De Maio
principal investigator · CHU Nimes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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