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RecruitingNCT06206590Updated Jan 16, 2024

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

An observational study in Neonatal Disease, sponsored by Guangdong Women and Children Hospital. Recruiting at 1 site in China. Open to participants aged 1 Day to 1 Day. Per ClinicalTrials.gov, last updated 2024-01-16.

Sponsored by Guangdong Women and Children Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
116
Ages
1 Day to 1 Day
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Neonatal Disease
03

In context

Infant, Newborn, Diseases

140 studies on the registry are indexed under Infant, Newborn, Diseases; 29 are open to participants now.

This study's planned enrollment of 116 is above the median of 100 across 49 observational studies indexed under Infant, Newborn, Diseases.

Browse Infant, Newborn, Diseases studies →

Lead sponsor

Guangdong Women and Children Hospital is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 1 Day
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newborns who born in Guangdong Women and Children Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not delivered in our hospital; congenital cardiovascular development malformation, fetal malformation, genetic metabolic diseases, etc
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
116 participants (estimated)
Patient registry
No

Groups and cohorts

  • exposed group

    Contains differential proteins

    Other: Whole-proteomic assay

  • non-exposed group

    No differential protein

    Other: Whole-proteomic assay

Interventions

  • OtherWhole-proteomic assay

    Whole-proteomic analysis was performed on all the blood samples

06

What researchers measure

Primary outcomes

  1. The incidence and mortality of shock

    Time frame: 1/10/2025

07

Study locations

1 of 1 sites recruiting
  • Guangdong Women and Children Hospital
    Guangzhou, Guangdong 510000, China
    Recruiting
    • xiuzhen ye, Master · Contactyxzh328@126.com · +8613725116591
    • dongju ma, Master · Sub investigator
    • yingyi lin, Master · Principal investigator
    • junjuan zhong, Master · Principal investigator
    • jing zhang, Master · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided — after the end of the study

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Sep 2025, 22 months after the start.

Of 32 observational studies under Infant, Newborn, Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 39. This study's planned 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2024
First posted
Jan 16, 2024
StartActual
Nov 1, 2023
Primary completionEst.
Sep 1, 2025
CompletionEst.
Dec 31, 2025
Last update
Jan 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06206590
Lead sponsor
Guangdong Women and Children Hospital
Responsible party
Ma Dongju (Physician, Guangdong Women and Children Hospital) — Principal investigator
First posted
Jan 16, 2024
Start date
Nov 1, 2023
Primary completion
Sep 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 16, 2024

Study contacts

dongju ma
Contact
864970051@qq.com
+86 188 9853 7230
xiuzhen ye
study chair · Guangdong Women and Children Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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