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NCT05055817 Clinical Trial

a Clinical Risk Score to Predict Bloody Stool in Neonates

Necrotizing Enterocolitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05055817
Other study ID # 2020204
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date December 31, 2024

Study information
Verified date October 2022
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 1 Minute to 28 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• bloody stool group
bloody stool appear in the hospitalized neonate
• non-bloody stool group
bloody stool do not appear in the hospitalized neonate

Locations
Country Name City State
China Children's Hospital of Chongqing Medical University Chongqing Chongqing

Sponsors (2)
Lead Sponsor Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary a Clinical Risk Score a Clinical Risk Score is developed in a retrospective cohort up to 28 days or discharge from hospital
Primary validation of a Clinical Risk Score a Clinical Risk Score is validation in another prospective cohort up to 28 days or discharge from hospital
See also
  Status Clinical Trial Phase
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Recruiting NCT03210831 - Early Predictors of Necrotizing Enterocolitis in Neonates
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Recruiting NCT02552706 - The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis N/A
Completed NCT02400697 - Placental Transfusion Project for Preterm Infants N/A
Completed NCT01751477 - Infloran® for Prevention of Necrotizing Enterocolitis N/A
Terminated NCT01156480 - Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Recruiting NCT01441739 - Intestinal Failure in Necrotising Enterocolitis N/A
Recruiting NCT03869827 - Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
Recruiting NCT04074824 - A Genome-Wide Association Study for Neonatal Diseases
Terminated NCT03320785 - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Active, not recruiting NCT03554278 - Alteration of Stool Microbiota in Preterm Infants With Anemia
Not yet recruiting NCT04541771 - The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Phase 2
Not yet recruiting NCT03700957 - The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Unknown status NCT01807858 - The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants N/A
Completed NCT01745510 - Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates Phase 1/Phase 2
Completed NCT01735578 - Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis N/A