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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome (ARDS); Red Blood Cells(RBC)
• Intervention / Treatment: Other: conventional treatment with RBC transfusion; Other: conventional treatment

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ma Juan, MD; Phone Number: 1388559467; Email: 476679422@qq.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 minutes to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RBC transfusion with conventional treatment; Besides conventional treatment,neonates diagnosed with ARDS is treated with RBC transfusion.	Other: conventional treatment with RBC transfusion; Besides conventional treatment, neonates is given RBC transfusion.
Active Comparator: conventional treatment; neonates diagnosed with ARDS is treated with conventional treatment.	Other: conventional treatment; neonates is treated with conventional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
death rate	neonate died due to respiratory failure	within 100 days

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Investigators: Principal Investigator: Shi Yuan, PhD,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 23, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 201732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No