a Clinical Risk Score to Predict Bloody Stool in Neonates

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT05055817

Collaborator

Children's Hospital of Chongqing Medical University (Other)

1,000

Enrollment

Location

Anticipated Duration (Months)

334.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bloody Stool Necrotizing Enterocolitis	Other: bloody stool group Other: non-bloody stool group

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Development and Validation of a Clinical Risk Score to Predict the Occurrence of Bloody Stool in Hospitalized Neonates in Non-neonatal Intensive Care Unit

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
bloody stool group bloody stool appear in the hospitalized neonate	Other: bloody stool group bloody stool appear in the hospitalized neonate
non-bloody stool group bloody stool do not appear in the hospitalized neonate	Other: non-bloody stool group bloody stool do not appear in the hospitalized neonate

Arm

Intervention/Treatment

bloody stool group

bloody stool appear in the hospitalized neonate

Other: bloody stool group

bloody stool appear in the hospitalized neonate

non-bloody stool group

bloody stool do not appear in the hospitalized neonate

Other: non-bloody stool group

bloody stool do not appear in the hospitalized neonate

Outcome Measures

Primary Outcome Measures

a Clinical Risk Score [up to 28 days or discharge from hospital]
a Clinical Risk Score is developed in a retrospective cohort
validation of a Clinical Risk Score [up to 28 days or discharge from hospital]
a Clinical Risk Score is validation in another prospective cohort

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Minute to 28 Days

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400042

Sponsors and Collaborators

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Children's Hospital of Chongqing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT05055817

Other Study ID Numbers:

2020204

First Posted:

Sep 24, 2021

Last Update Posted:

Sep 24, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Enterocolitis

Enterocolitis, Necrotizing

Study Results

No Results Posted as of Sep 24, 2021