a Clinical Risk Score to Predict Bloody Stool in Neonates | NCT05055817

Studies
a Clinical Risk Score to Predict Bloody Stool in Neonates

NCT05055817

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Status

Withdrawn

Last Update Posted

May 1, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Bloody Stool
Necrotizing Enterocolitis

Interventions

bloody stool group
non-bloody stool group

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no participants were included

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Sep 15, 2021

First Submission Date that Met QC Criteria

Sep 15, 2021

First Posted Date

Sep 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2023

Last Update Posted Date

May 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen Long,MD, director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityOTHER

Collaborators

Name	Class
Children's Hospital of Chongqing Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

NEC is characterized by vomit, abdominal distention, hypoactive bowel sounds and bloody stools, even shock, disseminated intravascular coagulation(DIC) and sepsis. X-ray is shown Intestinal wall gas and/or portal vein pneumatosis and pneumoperitoneum.

Bloody stool in newborn infant is a urgent condition, and neonatologist usually need to predict whether or not two and more grades of NEC it is.

Here, the investigators will develop a score system in one retrospective cohort to predict bloody stool, and the score system is validated in another prospective cohort.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
bloody stool group	Other	bloody stool appear in the hospitalized neonate	bloody stool group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

parents' rejection
main congenital malformation

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

28 Days

Standard Ages

Child

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Chongqing Medical University		Chongqing	Chongqing Municipality	400042	China

Condition Browse Module

MeSH Terms

ID	Term
D006471	Gastrointestinal Hemorrhage
D020345	Enterocolitis, Necrotizing

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

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Browse Branches

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