NCT06206590

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

January 4, 2024

Last Update Submit

January 4, 2024

Conditions

Neonatal Disease

Outcome Measures

Primary Outcomes (1)

  • The incidence and mortality of shock

    1/10/2025

Study Arms (2)

exposed group

Contains differential proteins

Other: Whole-proteomic assay

non-exposed group

No differential protein

Other: Whole-proteomic assay

Interventions

Whole-proteomic assayOTHER

Whole-proteomic analysis was performed on all the blood samples

exposed groupnon-exposed group

Eligibility Criteria

Age1 Day - 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborns who born in Guangdong Women and Children Hospital

You may qualify if:

  • All ≤32-week premature infants admitted to our NICU; All newborns delivered by the mother infected during pregnancy

You may not qualify if:

  • Not delivered in our hospital; congenital cardiovascular development malformation, fetal malformation, genetic metabolic diseases, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Women and Children Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • xiuzhen ye

    Guangdong Women and Children Hospital

    STUDY CHAIR

Central Study Contacts

dongju ma

CONTACT

+86 188 9853 7230864970051@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 16, 2024

Study Start

November 1, 2023

Primary Completion

September 1, 2025

Study Completion

December 31, 2025

Last Updated

January 16, 2024

Record last verified: 2024-01

Locations

CN(1)