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

NCT ID: NCT02598648

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-20
• Study Completion Date: 2023-09-30

Brief 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.

Detailed 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.

Conditions

Acute Respiratory Distress Syndrome; Acute Lung Injury; FXR; RIPK3

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ALI( acute lung injury)

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. FXR and RIPK3 were measured in neonate with ALI.

Group Type: OTHER

FXR

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

ARDS(respiratory distress syndrome)

ARDS :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.

FXR and RIPK3 were measured in neonate with ALI.were measured in another group neonate with ARDS

Group Type: OTHER

FXR

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

control

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. FXR and RIPK3 were measured in neonate with HIE

Group Type: OTHER

FXR

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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。

• Maximum Eligible Age: 1 Week
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Fang Wu

Principal Investigator Fang Wu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hu Zh Xue, Doctorate

Role: STUDY_DIRECTOR

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

Locations

NICU of Daping Hospital of the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wu Fang, Bachelor

Role: CONTACT

liuchengchun001@163.com

00862318696670405

Hu Zh Xue, Bachelor

Role: CONTACT

00862318696668598

Facility Contacts

WU FANG, Bachelor

Role: primary

00862318696670405

Other Identifiers

8157060555

Identifier Type: -

Identifier Source: org_study_id