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

NCT ID: NCT03296059

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2024-12-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RBC transfusion with conventional treatment

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

Group Type: EXPERIMENTAL

conventional treatment with RBC transfusion

Intervention Type: OTHER

Besides conventional treatment, neonates is given RBC transfusion.

conventional treatment

neonates diagnosed with ARDS is treated with conventional treatment.

Group Type: ACTIVE_COMPARATOR

conventional treatment

Intervention Type: OTHER

neonates is treated with conventional treatment.

Interventions

conventional treatment with RBC transfusion

Besides conventional treatment, neonates is given RBC transfusion.

Intervention Type: OTHER

conventional treatment

neonates is treated with conventional treatment.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Minutes
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ma Juan

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shi Yuan, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Locations

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ma Juan, MD

Role: CONTACT

476679422@qq.com

13508300283

Ma Juan, MD

Role: CONTACT

476679422@qq.com

1388559467

Facility Contacts

Shi Yuan, PhD,MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 38780066 (View on PubMed)

Other Identifiers

201732

Identifier Type: -

Identifier Source: org_study_id