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

Not Applicable

Recruiting

• Conditions: Red Blood Cells(RBC); Acute Respiratory Distress Syndrome (ARDS)
• Interventions: Other: conventional treatment with RBC transfusion; Other: conventional treatment

• Registration Number: NCT03296059
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-09-28
• Study Start: 2017-10-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-23
• Last Update Posted: 2022-10-25
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
death rate	within 100 days	neonate died due to respiratory failure

Trial Locations

Locations (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China