Role and Molecular Mechanism of Farnesoid X Receptor(FXR) and RIPK3 in the Formation of Acute Respiratory Distress Syndrome in Neonates

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Daping Hospital of the Third Military Medical University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02598648
• Other study ID #: 8157060555
• Status: Recruiting
• Phase: N/A
• 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
• 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?

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• FXR
• Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• RIPK3
• Syndrome

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