Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia

NCT06285604 | Active Not Recruiting

• 1 other identifier: IRB-20230398-R
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Clinical efficacy of different red blood cell products transfusion in anemic neonates

  The changes of hemoglobin concentration, crSo2 and cFTOE before and after transfusion were detected to evaluate the effects of different red blood cell products on brain oxygenation capacity of anemic neonates.

  The test results of each subject before and 24 hours after blood transfusion were analyzed.

• The changes of inflammatory response before and after transfusion in anemic neonates

  IL-6, IL-10 and CRP levels were measured, and the effect of infusion of different red blood cell products on the potential inflammatory response of anemic neonates was evaluated.

  The test results of each subject before and 24 hours after blood transfusion were analyzed.

Study Arms (3)

IRBC

Anemic neonates with irradiated red blood cells transfusions.

Procedure: Blood transfusion

WRBC

Anemic neonates with washed red blood cells transfusions.

Procedure: Blood transfusion

LPRBC

Anemic neonates with leukocyte privative red blood cells transfusions.

Procedure: Blood transfusion

Interventions

Blood transfusion PROCEDURE

Transfusion of designated red blood cell products to anemic neonates.

IRBC; LPRBC; WRBC

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Neonates who received blood transfusion at the Women's Hospital School of Medicine Zhejiang University from October 1, 2023 to September 30, 2025.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Anemia, Neonatal

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 29, 2024
• Study Start: September 10, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)