Analysis of Differential Proteins and Maternal Influencing Factors of Septic Shock in Neonates

Recruiting

• Conditions: Neonatal Disease
• Interventions: Other: Whole-proteomic assay

• Registration Number: NCT06206590
• Lead Sponsor: Guangdong Women and Children Hospital

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2023-11-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
exposed group	Whole-proteomic assay	Contains differential proteins
non-exposed group	Whole-proteomic assay	No differential protein

Primary Outcome Measures

Name	Time	Method
The incidence and mortality of shock	1/10/2025

Trial Locations

Locations (1)

Guangdong Women and Children Hospital; 🇨🇳 Guangzhou, Guangdong, China