Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03296059
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ma Juan, 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.


Condition or disease Intervention/treatment Phase
Red Blood Cells(RBC) Acute Respiratory Distress Syndrome (ARDS) Other: conventional treatment with RBC transfusion Other: conventional treatment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020


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.




Primary Outcome Measures :
  1. death rate [ Time Frame: within 100 days ]
    neonate died due to respiratory failure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296059


Contacts
Layout table for location contacts
Contact: Ma Juan, MD 13508300283 476679422@qq.com
Contact: Ma Juan, MD 1388559467 476679422@qq.com

Locations
Layout table for location information
China, Chongqing
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Shi Yuan, PhD,MD         
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
Layout table for investigator information
Principal Investigator: Shi Yuan, PhD,MD Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Layout table for additonal information
Responsible Party: Ma Juan, director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT03296059     History of Changes
Other Study ID Numbers: 201732
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury