Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia

NCT ID: NCT06285604

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2025-12-31

Brief Summary

The goal of this observational study is to evaluate the clinical efficacy of the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells, and to study the changes of inflammatory response before and after the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells in anemic neonates. The main questions it aims to answer are:

• Objective evaluation of the advantages and disadvantages of transfusion of different blood products in the treatment of neonatal anemia from the clinical efficacy.
• To provide objective basis for clinical rational use of blood in the selection of blood products.

Participants will be transfused with fresh irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells respectively according to relevant clinical and laboratory indicators.

Conditions

Neonatal Anemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

IRBC

Anemic neonates with irradiated red blood cells transfusions.

Blood transfusion

Intervention Type: PROCEDURE

Transfusion of designated red blood cell products to anemic neonates.

WRBC

Anemic neonates with washed red blood cells transfusions.

Blood transfusion

Intervention Type: PROCEDURE

Transfusion of designated red blood cell products to anemic neonates.

LPRBC

Anemic neonates with leukocyte privative red blood cells transfusions.

Blood transfusion

Intervention Type: PROCEDURE

Transfusion of designated red blood cell products to anemic neonates.

Interventions

Blood transfusion

Transfusion of designated red blood cell products to anemic neonates.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Neonates with stable hemodynamics who need blood transfusion are comprehensively evaluated by neonatologists according to their clinical conditions (heart, respiratory status, postnatal age, pregnancy at birth), laboratory indicators, etc. Diagnosis of Neonatal Septicemia:

• The mother had chorioamnionitis infection or Premature rupture of membranes (PROM) ≥18 h.
• The clinical diagnosis is that there are clinical abnormal manifestations, and any of the following conditions is met at the same time: ① blood non-specific examination ≥ 2 items are positive, ② cerebrospinal fluid examination is purulent meningitis change, and ③ pathogenic bacteria DNA is detected in blood.
• The diagnosis was confirmed as having clinical manifestations and positive blood culture or cerebrospinal fluid (or other sterile cavity fluid) culture.

Exclusion Criteria

• Infants with necrotizing enterocolitis (NEC) (current or previous).
• Feeding intolerance (defined as the decision of the treatment clinical team to suspend feeding / suspend feeding for at least 12 hours).
• RBC transfusion in the past 72 hours; Children who received ibuprofen / indomethacin / surgery 72 hours ago and / or severe congenital malformations such as congenital gastrointestinal tract, complex cardiopulmonary / fatal abnormalities or need emergency blood transfusion.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Guangyong Ye

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

IRB-20230398-R

Identifier Type: -

Identifier Source: org_study_id