Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

Official title:

Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03296059
• Other study ID #: 201732
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Ma Juan, MD
• Phone: 13508300283
• Email: 476679422[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.

The death rate is over 50%.There are no special treatments for acute respiratory distress syndrome.

Description:

Acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. There are few options for mechanical ventilation for such situations such as high frequency oscillation ventilation and extracorporeal membrane oxygenation. The aim of the present study is to determine whether transfusion of red blood cells can decrease the mortality in neonate with ARDS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Minutes to 1 Month

Eligibility

Inclusion Criteria:

• diagnosed with neonatal ARDS.

• informed parental consent has been obtained

Exclusion Criteria:

• major congenital malformations or complex congenital heart disease

• transferred out of the neonatal intensive care unit without treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Red Blood Cells(RBC)
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• conventional treatment with RBC transfusion
Besides conventional treatment, neonates is given RBC transfusion.
• conventional treatment
neonates is treated with conventional treatment.

Locations

Country	Name	City	State
China	Daping Hospital and the Research Institute of Surgery 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	death rate	neonate died due to respiratory failure	within 100 days