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

Primary Purpose

Red Blood Cells(RBC), Acute Respiratory Distress Syndrome (ARDS)

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
conventional treatment with RBC transfusion
conventional treatment
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Red Blood Cells(RBC)

Eligibility Criteria

30 Minutes - 1 Month (Child)All SexesDoes not accept 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

Sites / Locations

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RBC transfusion with conventional treatment

conventional treatment

Arm Description

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

neonates diagnosed with ARDS is treated with conventional treatment.

Outcomes

Primary Outcome Measures

death rate
neonate died due to respiratory failure

Secondary Outcome Measures

Full Information

First Posted
September 25, 2017
Last Updated
October 23, 2022
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03296059
Brief Title
Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates
Official Title
Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Red Blood Cells(RBC), Acute Respiratory Distress Syndrome (ARDS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RBC transfusion with conventional treatment
Arm Type
Experimental
Arm Description
Besides conventional treatment,neonates diagnosed with ARDS is treated with RBC transfusion.
Arm Title
conventional treatment
Arm Type
Active Comparator
Arm Description
neonates diagnosed with ARDS is treated with conventional treatment.
Intervention Type
Other
Intervention Name(s)
conventional treatment with RBC transfusion
Intervention Description
Besides conventional treatment, neonates is given RBC transfusion.
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
neonates is treated with conventional treatment.
Primary Outcome Measure Information:
Title
death rate
Description
neonate died due to respiratory failure
Time Frame
within 100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Juan, MD
Phone
13508300283
Email
476679422@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Juan, MD
Phone
1388559467
Email
476679422@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Yuan, PhD,MD
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi Yuan, PhD,MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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