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

Army Medical University of People's Liberation Army

Status: Enrolling

Conditions: Acute Respiratory Distress Syndrome (ARDS); Red Blood Cells(RBC)

Treatments: Other: conventional treatment with RBC transfusion; Other: conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03296059

201732

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 minutes to 1 month old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

RBC transfusion with conventional treatment

Experimental group

Description:

Besides conventional treatment,neonates diagnosed with ARDS is treated with RBC transfusion.

Treatment:

Other: conventional treatment with RBC transfusion

conventional treatment

Active Comparator group

Description:

neonates diagnosed with ARDS is treated with conventional treatment.

Treatment:

Other: conventional treatment