Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2017
CompletedFirst Posted
Study publicly available on registry
September 28, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedOctober 25, 2022
October 1, 2022
7.2 years
September 25, 2017
October 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
death rate
neonate died due to respiratory failure
within 100 days
Study Arms (2)
RBC transfusion with conventional treatment
EXPERIMENTALBesides conventional treatment,neonates diagnosed with ARDS is treated with RBC transfusion.
conventional treatment
ACTIVE COMPARATORneonates diagnosed with ARDS is treated with conventional treatment.
Interventions
Besides conventional treatment, neonates is given RBC transfusion.
Eligibility Criteria
You may qualify if:
- diagnosed with neonatal ARDS.
- informed parental consent has been obtained
You may not qualify if:
- major congenital malformations or complex congenital heart disease
- transferred out of the neonatal intensive care unit without treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
Related Publications (1)
Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
PMID: 38780066DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shi Yuan, PhD,MD
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director
Study Record Dates
First Submitted
September 25, 2017
First Posted
September 28, 2017
Study Start
October 1, 2017
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
October 25, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share