a Clinical Risk Score to Predict Bloody Stool in Neonates

NCT ID: NCT05055817

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Bloody Stool Necrotizing Enterocolitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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bloody stool group

bloody stool appear in the hospitalized neonate

bloody stool group

Intervention Type OTHER

bloody stool appear in the hospitalized neonate

non-bloody stool group

bloody stool do not appear in the hospitalized neonate

non-bloody stool group

Intervention Type OTHER

bloody stool do not appear in the hospitalized neonate

Interventions

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bloody stool group

bloody stool appear in the hospitalized neonate

Intervention Type OTHER

non-bloody stool group

bloody stool do not appear in the hospitalized neonate

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Chen Long,MD

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2020204

Identifier Type: -

Identifier Source: org_study_id

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