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

January 4, 2024 updated by: Ma Dongju, Guangdong Women and Children Hospital

Analysis of Differential Proteins and Maternal Influencing Factors of Septic Shock in Neonates Born to ≤32-week Preterm Infants or Infected Mothers During Pregnancy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangdong Women and Children Hospital
        • Contact:
        • Sub-Investigator:
          • dongju ma, Master
        • Principal Investigator:
          • yingyi lin, Master
        • Principal Investigator:
          • junjuan zhong, Master
        • Principal Investigator:
          • jing zhang, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newborns who born in Guangdong Women and Children Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
exposed group
Contains differential proteins
Other: Whole-proteomic assay
Whole-proteomic analysis was performed on all the blood samples
non-exposed group
No differential protein
Other: Whole-proteomic assay
Whole-proteomic analysis was performed on all the blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence and mortality of shock
Time Frame: 1/10/2025
1/10/2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Women and Children Hospital

Investigators

  • Study Chair: xiuzhen ye, Guangdong Women and Children Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Estimated)

January 15, 2024

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301393

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

after the end of the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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