Clinical trial NCT05089760: Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in China
Official title: Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in Chinese Neonatal Intensive Care Units
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Antimicrobial Resistance
Neonatal Sepsis
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Chinese Neonatal Network
First posted: 2021-10-22
Enrollment: 1200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall mortality
timeFrame: About 3 months from admission to discharge or death
Secondary outcomes:
measure: Sepsis-related mortality (within 7 days of sepsis)
timeFrame: About 3 months from admission to discharge or death
measure: Incidence of multiorgan dysfunction
timeFrame: About 3 months from admission to discharge or death
measure: Incidence of septic shock
timeFrame: About 3 months from admission to discharge or death
measure: Incidence of respiratory failure
timeFrame: About 3 months from admission to discharge or death
measure: Incidence of disseminated intravascular coagulation (DIC)
timeFrame: About 3 months from admission to discharge or death
measure: Incidence of renal failure
timeFrame: About 3 months from admission to discharge or death
measure: Incidence of meningitis
timeFrame: About 3 months from admission to discharge or death
measure: Incidence of necrotizing enterocolitis
timeFrame: About 3 months from admission to discharge or death
measure: Incidence of brain injury
timeFrame: About 3 months from admission to discharge or death
measure: Length of hospital stay
timeFrame: About 3 months from admission to discharge or death
measure: Length of antibiotic treatment
timeFrame: About 3 months from admission to discharge or death
measure: Type and quantity of transfusion
timeFrame: About 3 months from admission to discharge or death
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Fudan University, Shanghai, China
name: Yun Cao, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References: