NCT05055817

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• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 1 Minute – 28 Days
• Healthy volunteers: —

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.

Conditions

• Bloody Stool
• Necrotizing Enterocolitis

Interventions

Type	Name	Description
OTHER	bloody stool group	bloody stool appear in the hospitalized neonate
OTHER	non-bloody stool group	bloody stool do not appear in the hospitalized neonate

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-09-24
• Last updated: 2023-05-01

Locations

1 site across 1 country: China