Neonatal DiseaseNCT06206590
Analysis of Differential Proteins and Maternal Influencing Factors of Septic Shock in Neonates
An observational study of Neonatal Disease, run by Guangdong Women and Children Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 to 1 day
- Conditions the study is for
- Neonatal Disease
- What is being tested?
- Whole-proteomic assay
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: Newborns who born in Guangdong Women and Children Hospital
Who may be able to join
- All ≤32-week premature infants admitted to our NICU; All newborns delivered by the mother infected during pregnancy
Who cannot join
- Not delivered in our hospital; congenital cardiovascular development malformation, fetal malformation, genetic metabolic diseases, etc
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Women and Children Hospital
Guangzhou, Guangdong, 510000
xiuzhen ye, Master, +8613725116591, yxzh328@126.com
dongju ma, Master
About this study
Official title: Analysis of Differential Proteins and Maternal Influencing Factors of Septic Shock in Neonates Born to ≤32-week Preterm Infants or Infected Mothers During Pregnancy
- 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.
- Conditions
- Neonatal Disease
- Being tested
- Whole-proteomic assay
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-proteomic assayOther
Whole-proteomic analysis was performed on all the blood samples
| Study group | Role | What they receive |
|---|---|---|
| exposed group | Contains differential proteins Receives: Other: Whole-proteomic assay | |
| non-exposed group | No differential protein Receives: Other: Whole-proteomic assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and mortality of shock
Measured: 1/10/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Nov 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Dongju, Guangdong Women and Children Hospital
- Investigators
- xiuzhen ye, Study chair, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206590
- Sponsor's protocol ID
- 202301393
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Differential Proteins and Maternal Influencing Factors of Septic Shock in Neonates Born to ≤32-week Preterm Infants or Infected Mothers During Pregnancy
- ClinicalTrials.gov ID
- NCT06206590
- Acronym / sponsor ID
- 202301393
- Conditions
- Neonatal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed group | – | Other: Whole-proteomic assayContains differential proteins |
| non-exposed group | – | Other: Whole-proteomic assayNo differential protein |
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns who born in Guangdong Women and Children Hospital
Key inclusion criteria (1 listed)
- All ≤32-week premature infants admitted to our NICU; All newborns delivered by the mother infected during pregnancy
Key exclusion criteria (1 listed)
- Not delivered in our hospital; congenital cardiovascular development malformation, fetal malformation, genetic metabolic diseases, etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-proteomic assayWhole-proteomic analysis was performed on all the blood samples | Other | exposed group, non-exposed group |
Primary outcome
The incidence and mortality of shock
Time frame: 1/10/2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: Undecided. after the end of the study
Related trials for Neonatal Disease
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiuzhen ye study chair
Guangdong Women and Children Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Disease, run by Guangdong Women and Children Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dongju ma (+86 188 9853 7230, 864970051@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and mortality of shock (time frame: 1/10/2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.