Neonatal AnemiaNCT06285604
Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia
An observational study of Neonatal Anemia, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Neonatal Anemia
- What is being tested?
- Blood transfusion
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
About this study
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
- Being tested
- Blood transfusion
- Medical subject headings
- Anemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionProcedure or surgery
Transfusion of designated red blood cell products to anemic neonates.
| Study group | Role | What they receive |
|---|---|---|
| IRBC | Anemic neonates with irradiated red blood cells transfusions. Receives: Procedure: Blood transfusion | |
| WRBC | Anemic neonates with washed red blood cells transfusions. Receives: Procedure: Blood transfusion | |
| LPRBC | Anemic neonates with leukocyte privative red blood cells transfusions. Receives: Procedure: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The test results of each subject before and 24 hours after blood transfusion were analyzed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start10 Sep 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangyong Ye, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285604
- Sponsor's protocol ID
- IRB-20230398-R
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia
- ClinicalTrials.gov ID
- NCT06285604
- Acronym / sponsor ID
- IRB-20230398-R
- Conditions
- Neonatal Anemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IRBC | – | Procedure: Blood transfusionAnemic neonates with irradiated red blood cells transfusions. |
| WRBC | – | Procedure: Blood transfusionAnemic neonates with washed red blood cells transfusions. |
| LPRBC | – | Procedure: Blood transfusionAnemic neonates with leukocyte privative red blood cells transfusions. |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood transfusionTransfusion of designated red blood cell products to anemic neonates. | Procedure or surgery | IRBC, LPRBC, WRBC |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Anemia, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.