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Clinical research of Prediction of early onset intrauterial bacterial infection in neonates.

Clinical research of Prediction of early onset intrauterial bacterial infection in neonates.

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025353
Enrollment
Unknown
Registered
2019-08-24
Start date
2016-09-18
Completion date
Unknown
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial early-onset neonatal infection

Interventions

Gold Standard:1.It has clinical manifestations of infection and accords with any of the following
2. Pathogenic bacteria results are positive in blood or aseptic body fluid culture
3. If opportunistic pathogens can be cultured in blood culture, homologous bacteria must be cultured in another part of blood, or in aseptic body
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Sponsors

Qingpu Branch, Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Newborns with high risk factors for infection such as premature rupture of membranes, gestational diabetes mellitus and muddy amniotic fluid, or completely normal; 2. Cases with gestational age of 37-42 weeks; 3. Neonates of boys or girls; 4. Neither mother nor newborn received antibiotic treatment; 5. Mothers did not use hormones or other drugs in the third trimester of pregnancy; 6. Neonates have no serious heart, lung, liver, kidney and other important organ dysfunction; 7. Neonatal organ-free tissue deformity and various hereditary diseases; 8. Written informed consent with exact date obtained.

Exclusion criteria

Exclusion criteria: 1. Neonates have any diseases other than infection such as organ malformations and various hereditary diseases, as well as heart, lung, liver, kidney and other important organ dysfunction; 2. Neonates with marked symptoms of viral or fungal infections, or mothers have history of fungal or viral infections; 3. Mothers have diseases that affect the level of biomarkers in the blood, such as organ inflammation, heart disease and cancer; 4. Mothers and newborns were treated with antibiotics before cord blood samples was collected; 5. Mothers used hormones, immunosuppressants and other drugs in the third trimester of pregnancy; 6. The discharged cases within 7 days after birth can not cooperate with 7 days follow-up due to psychological, social, family and geographical reasons; 7. Informed consent refusal.

Design outcomes

Primary

MeasureTime frame
CD64;TREM-1;

Countries

China

Contacts

Public ContactXu Lingmin

Qingpu Branch, Zhongshan Hospital Affiliated to Fudan University

xulingmin6303@163.com+86-18116016303

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026