a Clinical Risk Score to Predict Bloody Stool in Neonates

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05055817

Enrollment

Registered

2021-09-24

Start date

2021-10-01

Completion date

2024-12-31

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloody Stool, Necrotizing Enterocolitis

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.

Interventions

OTHERbloody stool group

bloody stool appear in the hospitalized neonate

OTHERnon-bloody stool group

bloody stool do not appear in the hospitalized neonate

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 28 Days

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026