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OpenTrials
Active, Not Recruiting

NCT Number: NCT06285604

Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Transfusion

Procedure

Transfusion of designated red blood cell products to anemic neonates.

Primary outcomes

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

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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