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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2024

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: RBC transfusion with conventional treatment
    • Besides conventional treatment,neonates diagnosed with ARDS is treated with RBC transfusion.
  • Active Comparator: conventional treatment
    • neonates diagnosed with ARDS is treated with conventional treatment.

Clinical Trial Outcome Measures

Primary Measures

  • death rate
    • Time Frame: within 100 days
    • neonate died due to respiratory failure

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Minutes

Maximum Age: 1 Month

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ma Juan, director – Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Overall Official(s)
    • Shi Yuan, PhD,MD, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Overall Contact(s)
    • Ma Juan, MD, 13508300283, 476679422@qq.com

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