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

NCT ID: NCT06206590

Last Updated: 2024-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Neonatal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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exposed group

Contains differential proteins

Whole-proteomic assay

Intervention Type OTHER

Whole-proteomic analysis was performed on all the blood samples

non-exposed group

No differential protein

Whole-proteomic assay

Intervention Type OTHER

Whole-proteomic analysis was performed on all the blood samples

Interventions

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Whole-proteomic assay

Whole-proteomic analysis was performed on all the blood samples

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Women and Children Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ma Dongju

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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xiuzhen ye

Role: STUDY_CHAIR

Guangdong Women and Children Hospital

Locations

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Guangdong Women and Children Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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dongju ma

Role: CONTACT

+86 188 9853 7230

Facility Contacts

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xiuzhen ye, Master

Role: primary

+8613725116591

Other Identifiers

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202301393

Identifier Type: -

Identifier Source: org_study_id

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