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

Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03296059
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
60
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: conventional treatment with RBC transfusion
  • Other: conventional treatment
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates: A Randomized Controlled Trial
Actual Study Start Date :
Oct 1, 2017
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. death rate [within 100 days]

    neonate died due to respiratory failure

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Minutes to 1 Month
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Chongqing Chongqing China 400042

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ma Juan, director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier:
NCT03296059
Other Study ID Numbers:
  • 201732
First Posted:
Sep 28, 2017
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome

Study Results

No Results Posted as of Feb 16, 2021