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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06206590
Other study ID # 202301393
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source Guangdong Women and Children Hospital
Contact dongju ma
Phone +86 188 9853 7230
Email 864970051@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. Explore 32 weeks of premature infants or maternal pregnancy infection of newborn septic shock maternal influence factors. 2. Through maternal blood samples before delivery and labor cord blood sample screening and septic shock related proteomics analysis, explore the relationship between the difference protein and septic shock and prognosis, and explore the pathway mechanism, in order to prevent and reduce the occurrence of septic shock in premature infants


Description:

The birth cohort was established with 32 weeks of premature infants or maternal infection during pregnancy.Whole proteomic analysis was performed on maternal blood before delivery and umbilical cord blood samples at delivery,and screscreen differential proteins associated with septic shock and classify these proteins as leak factor into exposed and non-exposed groups for cohort study.The incidence and mortality of shock,severe brain injury and BPD in the two groups were compared, and the mechanism of the differential protein was studied to provide early warning in children with septic shock.


Recruitment information / eligibility

Status Recruiting
Enrollment 116
Est. completion date December 31, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Day to 1 Day
Eligibility Inclusion Criteria: - All =32-week premature infants admitted to our NICU; All newborns delivered by the mother infected during pregnancy Exclusion Criteria: - Not delivered in our hospital; congenital cardiovascular development malformation, fetal malformation, genetic metabolic diseases, etc

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Whole-proteomic assay
Whole-proteomic analysis was performed on all the blood samples

Locations

Country Name City State
China Guangdong Women and Children Hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Women and Children Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence and mortality of shock 1/10/2025
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