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NCT Number: NCT04584320

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Necrotizing Enterocolitis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Stool sample

Other

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

Primary outcomes

  1. Presence of C. butyricum

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

    PCR

  2. Presence of C. neonatale

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

    PCR

  3. Culture of C. butyricum

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

    Growth on selective media

  4. Culture of C. neonatale

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

    Growth on selective media

Secondary outcomes

  1. Localisation within the hospital

    Time frame: During hospitalization (maximum 120 days)

    Bed numbers occupied

Other outcomes

  1. Age of mother

    Time frame: Day 0

    Years

  2. Body mass index of mother

    Time frame: Day 0

    Kg/m2

  3. Parity of mother

    Time frame: Day 0

  4. Gravidity of mother

    Time frame: Day 0

  5. Professional activity of mother

    Time frame: Day 0

    Yes/no; description

  6. Smoking status of mother

    Time frame: Day 0

    Yes/no

  7. Chronic pathology of mother

    Time frame: Day 0

    Yes/no, description

  8. Allergy of mother

    Time frame: Day 0

    Yes/no, description

  9. Number of years of schooling of mother

    Time frame: Day 0

  10. Exposure to magnesium sulfate during pregnancy

    Time frame: Day 0

    Yes/no

  11. Cause of prematurity

    Time frame: Day 0

  12. Method of delivery

    Time frame: Day 0

    Vagina/Caesarean

  13. Anesthesia during delivery

    Time frame: Day 0

    General/spinal

  14. Mode of delivery of vaginal birth

    Time frame: Day 0

    Spontaneous/instrumental

  15. Spontaneous rupture of membranes

    Time frame: Day 0

    Yes/no

  16. Time of rupture of membranes before birth

    Time frame: Day 0

    <12h/>12h

  17. Pathology during pregnancy

    Time frame: Day 0

    Yes/No; description

  18. Birth term

    Time frame: Day 0

    Weeks and days

  19. Birth weight

    Time frame: Day 0

    grams

  20. Birth weight percentile

    Time frame: Day 0

    percentile

  21. Birth height

    Time frame: Day 0

    cm

  22. Birth height ; percentile

    Time frame: Day 0

    percentile

  23. Intubation

    Time frame: Day 0

    Yes/no

  24. umbilical venous catheter

    Time frame: Day 0

    Yes/no; duration

  25. Epicutaneo-cava catheter

    Time frame: Day 0

    Yes/no; duration

  26. Daily lipid intake per os per kilp

    Time frame: During hospitlization (maximum 120 days)

    g/kg

  27. Presence of sequelae

    Time frame: During hospitalization (maximum 120 days)

    Yes/no

  28. Type of sequelae

    Time frame: During hospitalization (maximum 120 days)

    description

  29. Hemodynamically significant patent ductus arteriosus

    Time frame: During hospitalization (maximum 120 days)

    Yes/no

  30. Type of milk

    Time frame: During hospitalization (maximum 120 days)

    pasteurized/fresh/artificial

  31. Duration of milk intake

    Time frame: During hospitalization (maximum 120 days)

    Days

  32. Probiotic intake duration

    Time frame: During hospitalization (maximum 120 days)

    Days

  33. Types of probiotic taken

    Time frame: During hospitalization (maximum 120 days)

    Type

  34. Type of antibiotics taken in post-natal period

    Time frame: During hospitalization (maximum 120 days)

    Type

  35. Duration of antibiotic treatment in post-natal period

    Time frame: During hospitalization (maximum 120 days)

    Days

  36. Type of vasoactive amines taken

    Time frame: During hospitalization (maximum 120 days)

    Type

  37. Duration of vasoactive amine treatment

    Time frame: During hospitalization (maximum 120 days)

    Days

  38. Type of any postnatal surgery

    Time frame: During hospitalization (maximum 120 days)

    Type

  39. Total duration of parenteral feeding

    Time frame: During hospitalization (maximum 120 days)

    Days

  40. Ibuprofen

    Time frame: During hospitalization (maximum 120 days)

    Yes/no

  41. Hemodynamic shock

    Time frame: During hospitalization (maximum 120 days)

    Yes/no

  42. Labile Blood Product transfusion

    Time frame: During hospitalization (maximum 120 days)

    Amount

  43. antenatal corticosteroid therapy

    Time frame: Day 0

    Complete/incomplete

  44. Type of post-natal corticosteroid therapy

    Time frame: During hospitalization (maximum 120 days)

    Type

  45. Duration of post-natal corticosteroid therapy

    Time frame: During hospitalization (maximum 120 days)

    Days

  46. Exposure to ante- and post-natal antibiotics

    Time frame: During hospitalization (maximum 120 days)

    Description

  47. umbilical arterial catheter

    Time frame: Day 0

    Duration

  48. Nosocomial infection

    Time frame: During hospitalization (maximum 120 days)

    Proven/suspected

  49. Nosocomial infection infective agent

    Time frame: During hospitalization (maximum 120 days)

    name

  50. Rectal bleeding

    Time frame: During hospitalization (maximum 120 days)

    Number

  51. metabolic acidosis

    Time frame: During hospitalization (maximum 120 days)

    Yes/no

  52. Volume of alimentation per kilo

    Time frame: During hospitalization (maximum 120 days)

  53. Daily carbohydrate intake per os per kilp

    Time frame: During hospitalization (maximum 120 days)

    g/kg

  54. Daily proteins intake per os per kilp

    Time frame: During hospitalization (maximum 120 days)

    g/kg

  55. Volume of daily total alimentation

    Time frame: During hospitalization (maximum 120 days)

  56. Cranial circumference

    Time frame: Day 0

    cm; percentile

  57. Cranial circumference percentile

    Time frame: Day 0

    percentile

  58. Other catheter

    Time frame: Day 0

    Type

  59. Duration of other catheter

    Time frame: Day 0

    Days

  60. Enriched maternal milk

    Time frame: During hospitalization (maximum 120 days)

    Maximum percentage

  61. Milk thickening

    Time frame: During hospitalization (maximum 120 days)

    Duration

  62. Chorioamnionitis

    Time frame: During hospitalization (maximum 120 days)

    Proven/suspected

  63. Materno-fetal infection

    Time frame: Day 0

    Proven/suspected

  64. Materno-fetal infection infective agent

    Time frame: Day 0

    name

  65. pneumatosis-pneumoportia

    Time frame: During hospitalization (maximum 120 days)

    Yes/no

  66. Transfer

    Time frame: During hospitalization (maximum 120 days)

    Yes/no

  67. Time of occurence of ulcerative necrotizing enterocolitis

    Time frame: During hospitalization (maximum 120 days)

    weeks post-natal

  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

    Time frame: During hospitalization (maximum 120 days)

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Qualitative and Quantitative 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 Their Hospitalization in Neonatology

Acronym: ECUN-2

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Oct 12, 2020
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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