NCT05619055

Brief Summary

Study Description The goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. The main questions it aims to answer are:

  • 1\. Whether there is intestinal flora in the stool of premature infants.
  • 2\. Are there dysregulated intestinal flora and their metabolic products in premature infants diagnosed as necrotizing enterocolitis.
  • 3\. The detailed role and underlying mechanism of the intestinal dysbacteriosis and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. Participants, premature infants diagnosed as necrotizing enterocolitis (NEC group), will be asked to collect stool (usually 2 times) for intestinal flora analysis. If there is a comparison group: Researchers will compare premature infants without necrotizing enterocolitis (control group) to see if their intestinal flora and the metabolic products also changed as their NEC counterparts.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

November 5, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

2.4 years

First QC Date

November 2, 2022

Last Update Submit

November 8, 2022

Conditions

Necrotizing Enterocolitis of Newborn

Keywords

Necrotizing Enterocolitisintestinal flora

Outcome Measures

Primary Outcomes (7)

  • intestinal flora

    the intestinal flora in the stool using 16S ribosomal RNA(rRNA) gene sequencing

    up to 4 weeks

  • short-chain fatty acids

    short-chain fatty acids, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing

    up to 4 weeks

  • neurotransmitters

    neurotransmitters, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing

    up to 4 weeks

  • lipopolysaccharide

    lipopolysaccharide, a metabolic product of intestinal flora, in the stool using 16S rRNA gene sequencing

    up to 4 weeks

  • L-FABP

    L-FABP, the injury marker of intestinal mucosa, in the blood

    up to 4 weeks

  • I-FABP

    I-FABP, the injury marker of intestinal mucosa, in the blood

    up to 4 weeks

  • hospital stay

    one vital clinical outcome of the premature infants

    up to 4 weeks

Secondary Outcomes (4)

  • X-ray

    up to 4 weeks

  • complete blood count

    up to 4 weeks

  • c-reactive protein

    up to 4 weeks

  • procalcitonin

    up to 4 weeks

Study Arms (2)

neonate with necrotizing enterocolitis

premature infants diagnosed as necrotizing enterocolitis

Other: Routine treatment

neonate without necrotizing enterocolitis

premature infants without necrotizing enterocolitis

Other: Routine treatment

Interventions

Routine treatmentOTHER

Antibiotics, intravenous fluids and symptomatic supportive treatment.

neonate with necrotizing enterocolitisneonate without necrotizing enterocolitis

Eligibility Criteria

Age5 Days - 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Hospitalized children in Neonatology

You may qualify if:

  • clinical diagnosis of Necrotizing Enterocolitis,
  • gestational age \<37 weeks,
  • body weight 1,000-2,500 g,
  • postnatal Apgar score ≥7,
  • initial oral feeding tolerance.

You may not qualify if:

  • serious hereditary or other serious diseases, such as heart, lung and abdominal malformations ,
  • early or late onset septicemia,
  • early use of antibiotics in the newborn,
  • serious adverse reactions caused by probiotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Zuohui Zhao, Dr

    Shandong First Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zuohui Zhao, Dr

CONTACT

0086-531-89268509zhaozuohui@126.com

Jiahui Li, Dr

CONTACT

0086-531-892685082149@sdhospital.com.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 16, 2022

Study Start

November 5, 2022

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

November 16, 2022

Record last verified: 2022-11

Locations

CN(1)