NCT02598648

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

8 years

First QC Date

November 4, 2015

Last Update Submit

October 13, 2022

Conditions

Keywords

FXRRIPK3NeonatesAcute Respiratory Distress SyndromeAcute Lung Injury

Outcome Measures

Primary Outcomes (1)

  • FXR

    6 hours later

Secondary Outcomes (3)

  • chest-X-ray

    1 hours later

  • RIPK3

    6 hours later

  • blood gas

    1 hours later

Study Arms (3)

ALI( acute lung injury)

OTHER

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.

Other: FXROther: RIPK3

ARDS(respiratory distress syndrome)

OTHER

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

Other: FXROther: RIPK3

control

OTHER

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

Other: FXROther: RIPK3

Interventions

FXROTHER

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

ALI( acute lung injury)ARDS(respiratory distress syndrome)control
RIPK3OTHER

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.

ALI( acute lung injury)ARDS(respiratory distress syndrome)control

Eligibility Criteria

AgeUp to 1 Week
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NICU of Daping Hospital of the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Study Officials

  • Hu Zh Xue, Doctorate

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

    STUDY DIRECTOR

Central Study Contacts

Hu Zh Xue, Bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Fang Wu

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 6, 2015

Study Start

September 20, 2015

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations