NCT05055817

Brief Summary

Bloody stool is a main focus in non-neonatal intensive care unit ward, and it is one of the risk factors in neonates with subsequent necrotizing enterocolitis(NEC) and usually lead to longed duration of hospitalization. NEC is one of the most serious disease in the newborn infants, and two and more grades of NEC might lead to surgery, even death. But, it is difficult to predict when the bloody stool comes and develop to two and more grades of NEC.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 15, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 1, 2023

Status Verified

October 1, 2022

Enrollment Period

3.3 years

First QC Date

September 15, 2021

Last Update Submit

April 28, 2023

Conditions

Bloody StoolNecrotizing Enterocolitis

Outcome Measures

Primary Outcomes (2)

  • a Clinical Risk Score

    a Clinical Risk Score is developed in a retrospective cohort

    up to 28 days or discharge from hospital

  • validation of a Clinical Risk Score

    a Clinical Risk Score is validation in another prospective cohort

    up to 28 days or discharge from hospital

Study Arms (2)

bloody stool group

bloody stool appear in the hospitalized neonate

Other: bloody stool group

non-bloody stool group

bloody stool do not appear in the hospitalized neonate

Other: non-bloody stool group

Interventions

bloody stool groupOTHER

bloody stool appear in the hospitalized neonate

bloody stool group
non-bloody stool groupOTHER

bloody stool do not appear in the hospitalized neonate

non-bloody stool group

Eligibility Criteria

Age1 Minute - 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

neonates with more than or equal to 35 weeks' GA and less than or equal to 28 days in non-neonatal intensive care unit ward are included.

You may qualify if:

  • more than or equal to 35 weeks' gestational age(GA)
  • less than or equal to 28 days
  • non-neonatal intensive care unit ward

You may not qualify if:

  • parents' rejection
  • main congenital malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Gastrointestinal HemorrhageEnterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsEnterocolitisGastroenteritisIntestinal Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

September 15, 2021

First Posted

September 24, 2021

Study Start

October 1, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 1, 2023

Record last verified: 2022-10

Locations

CN(1)