Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Antimicrobial Resistance; Neonatal Sepsis
• Intervention / Treatment: Other: No intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Yun Cao, Ph.D. M.D.; Phone Number: +8602164931160; Email: yuncao@fudan.edu.cn
• Study Contact Backup: Name: Siyuan Jiang, Ph.D. M.D.; Phone Number: +8602164931160; Email: jane1350@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 month (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All neonates diagnosed with culture-proven sepsis and admitted to CHNN NICUs from 2022.1.1 to 2023.12.31

Description

Inclusion Criteria:

• Admitted to CHNN NICUs from 2022.1.1 to 2023.12.31
• Diagnosed with culture-proven sepsis

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Infants with bacteria sepsis; Infants diagnosed with culture-proven sepsis

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality	Incidence of death during the study period	About 3 months from admission to discharge or death

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of multiorgan dysfunction	Propertion of infants who occur multiorgan dysfunction	About 3 months from admission to discharge or death
Incidence of septic shock	Propertion of infants who occur septic shock	About 3 months from admission to discharge or death
Incidence of respiratory failure	Propertion of infants who occur respiratory failure	About 3 months from admission to discharge or death
Incidence of disseminated intravascular coagulation (DIC)	Propertion of infants who occur DIC	About 3 months from admission to discharge or death
Incidence of renal failure	Propertion of infants who accur renal failure	About 3 months from admission to discharge or death
Incidence of meningitis	Propertion of infants who accur meningitis	About 3 months from admission to discharge or death
Incidence of necrotizing enterocolitis	Propertion of infants who accur necrotizing enterocolitis	About 3 months from admission to discharge or death
Incidence of brain injury	Propertion of infants who accur brain injury	About 3 months from admission to discharge or death
Length of hospital stay	Days of hospitalization	About 3 months from admission to discharge or death
Length of antibiotic treatment	Days of antibiotic treatment	About 3 months from admission to discharge or death
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Chinese Neonatal Network
• Investigators: Principal Investigator: Yun Cao, Ph.D, M.D., Children's Hospital of Fudan University, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis
• Other Study ID Numbers: MAROC-ChiNICU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No