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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02598648
Other study ID # 8157060555
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 20, 2015
Est. completion date September 30, 2023

Study information

Verified date October 2022
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact Wu Fang, Bachelor
Phone 00862318696670405
Email liuchengchun001@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the clinical data, the changes of RIPK3 and FXR were monitored in the lung lavage fluid and blood from the patients. In vivo experiments to find high risk factors to induce AEC necrosis and further lead to ARDS evidence, can provide a more direct theoretical research foundation for the pathogenesis of ARDS.


Description:

Divided into 3 Arms ALI :Diagnostic criteria: 1.Acute onset;2.FiO2/ PaO2< 40.0 kPa (300mmHg, ALI); 3.Chest X-ray showed that the double lung texture increased, the increase of crude, fuzzy, visible diffuse patchy infiltration shadow with compensatory emphysema, for the most early performance; B. double lung field large sheet, asymmetric, edge fuzzy infiltration shadow, the most dense in the lung;4. Echocardiography, left atrial hypertension; 5.The gestational age >35 week, have maternal age cholestasis (severe), sepsis or meconium aspiration syndrome (MAS) understanding of history, and with the exception of the primary pulmonary surfactant (PS) lack of. ARDS :Pediatric acute respiratory distress syndrome (ARDS) is a severe lung injury caused by pneumonia, sepsis, and trauma.Diagnostic criteria: 1.Acute onset;2.FiO2/ PaO2< 26.7 kPa (200mmHg, ARDS); 3.Chest X-ray showed that the double lung transparent brightness is generally lower, the glass sample, with bronchial inflatable sign, and even double lung field common density increased, the heart shadow is not clear, a white lung, as the most important performance;4. Echocardiography, left atrial hypertension; 5.The gestational age >35 week, have maternal age cholestasis (severe), sepsis or meconium aspiration syndrome (MAS) understanding of history, and with the exception of the primary pulmonary surfactant (PS) lack of;6.Need to use a ventilator. Control group: Patients with mechanical ventilation due to external causes of the lung, no ALI-ARDS performance,FiO2/ PaO2< 40.0 kPa (300 mmHg), such as premature apnea or HIE.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Week
Eligibility Inclusion Criteria:According to the diagnostic criteria, the diagnosis was ALI or ARDS; Exclusion Criteria:Severe congenital or hereditary disease of the newborn, is clearly diagnosed as NRDS, which is caused by the lack of the primary PS?

Study Design


Related Conditions & MeSH terms


Intervention

Other:
FXR
FXR could elevate the transcription of RIPK3, a key protein in necroptosis, and play important role in bile aicd induced alveolar epithelial cell(AEC) necroptosis. FXR were measured in neonate with ALI?ARDS and control
RIPK3
FXR(farnesoid-X-receptor) could elevate the transcription of RIPK3, a key protein in necroptosis, and play important role in bile aicd induced alveolar epithelial cell(AEC) necroptosis. RIPK3 were measured in neonate with ALI?ARDS and control.

Locations

Country Name City State
China NICU of Daping Hospital of the Third Military Medical University ChongQing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary FXR 6 hours later
Secondary chest-X-ray 1 hours later
Secondary RIPK3 6 hours later
Secondary blood gas 1 hours later
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