Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China

Neonatal Sepsis Clinical Trial

Official title:

Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in Chinese Neonatal Intensive Care Units

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05089760
• Other study ID #: MAROC-ChiNICU
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Children's Hospital of Fudan University
• Contact: Yun Cao, Ph.D. M.D.
• Phone: +8602164931160
• Email: yuncao[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Neonatal sepsis remains one of the most important cause of mortality and morbidities in China. This study will establish a prospective registral cohort of all infants with culture-proven neonatal sepsis in Chinese NICUs participating in the Chinese Neonatal Network (CHNN). The microbiology, antimicrobial resistance patterns and neonatal outcomes will be described in detail for this cohort.

Description:

All infants with culture-proven sepsis in NICUs of CHNN will be enrolled in the study. Detailed data on microbiology, resistance pattern, neonatal mortality and morbidities will be collected and described. Risk factors for multi-resistant bacteria infections and for sepsis-related mortality will be identified.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 1 Month

Eligibility

Inclusion Criteria:

• Admitted to CHNN NICUs from 2022.1.1 to 2023.12.31

• Diagnosed with culture-proven sepsis

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Antimicrobial Resistance
• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

Other:
• No intervention
This is a prospective observational cohort study. The purpose of the study was to compare the incidence of mortality, complications, and other outcomes between infants with multi-resistant bacteria sepsis and infants with sepsis caused by non-multi-resistant bacteria, and compare the incidence of complications and other outcomes between infants with sepsis-related death and infants who survive.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Chinese Neonatal Network

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality	Incidence of death during the study period	About 3 months from admission to discharge or death
Secondary	Sepsis-related mortality (within 7 days of sepsis)	Incidence of death within 7 days after sepsis	About 3 months from admission to discharge or death
Secondary	Incidence of multiorgan dysfunction	Propertion of infants who occur multiorgan dysfunction	About 3 months from admission to discharge or death
Secondary	Incidence of septic shock	Propertion of infants who occur septic shock	About 3 months from admission to discharge or death
Secondary	Incidence of respiratory failure	Propertion of infants who occur respiratory failure	About 3 months from admission to discharge or death
Secondary	Incidence of disseminated intravascular coagulation (DIC)	Propertion of infants who occur DIC	About 3 months from admission to discharge or death
Secondary	Incidence of renal failure	Propertion of infants who accur renal failure	About 3 months from admission to discharge or death
Secondary	Incidence of meningitis	Propertion of infants who accur meningitis	About 3 months from admission to discharge or death
Secondary	Incidence of necrotizing enterocolitis	Propertion of infants who accur necrotizing enterocolitis	About 3 months from admission to discharge or death
Secondary	Incidence of brain injury	Propertion of infants who accur brain injury	About 3 months from admission to discharge or death
Secondary	Length of hospital stay	Days of hospitalization	About 3 months from admission to discharge or death
Secondary	Length of antibiotic treatment	Days of antibiotic treatment	About 3 months from admission to discharge or death
Secondary	Type and quantity of transfusion	Which kind and how much (ml) of blood product was used during the study	About 3 months from admission to discharge or death