Anemia of PrematurityNCT02101086
Autologous Cord Blood Transfusion in Preterm Infants
A study testing Blood transfusion in people with Anemia of Prematurity, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the efficacy and safety of autologous cord blood transfusions in very-low-birth-weight premature infants, and to evaluate the developmental outcomes of the infants who received autologous transfusions. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Anemia of Prematurity
- What is being tested?
- Blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born at ≤ 32 weeks gestational age
- Parental consent
Who cannot join
- rhesus incompatibility
- hydrops fetalis
- maternal viral or bacterial infections including suspected chorioamnionitis
- parental refuse
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School of Medicine
Ankara, 06100
About this study
Official title: Evaluation of the Efficacy and Safety of Autologous Cord Blood Transfusions in Premature Infants
The purpose of this study is to investigate the efficacy and safety of autologous cord blood transfusions in very-low-birth-weight premature infants, and to evaluate the developmental outcomes of the infants who received autologous transfusions.
Read the detailed description
Blood transfusions have many risks including transfusion reactions and infections. Cord blood is accepted as an alternative method for red cell transfusions in low-birth weight (LBW) premature newborns. However, experience and scientific evidence concerning in-vivo efficacy and safety of red blood cell (RBC) concentrates derived from cord blood in very LBW premature newborns is still insufficient.
A total of 50 umbilical cord blood (UCB) collected from infants born before 32 weeks' gestational age and processed into autologous RBC products. Infants requiring blood transfusion were randomly assigned to an autologous or allogeneic product. Two randomized groups were compared on the 14th, 28th, 35th days and >35th days with respect to hemoglobin levels, transfusion numbers, transfusion and phlebotomy volumes, and hemoglobin, reticulocyte counts and erythropoietin levels in the postconceptional 36th and 40th weeks' gestation, and hemoglobin levels at postnatal 6-months age. All transfused infants were developmentally assessed by the end of the postnatal first year.
- Conditions
- Anemia of Prematurity
- Being tested
- Blood transfusion
- Keywords
- umbilical cord blood, premature, autologous transfusion, allogeneic transfusion
- Medical subject headings
- Anemia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionOther
Whenever the infant indicated to receive transfusion, a blood product request was sent to the blood bank. This infant was randomly assigned to the autologous or the allogeneic product labeled for each patient at birth in the blood bank
| Study group | Role | What they receive |
|---|---|---|
| Autologous Cord Blood Transfusion | Experimental | Autologous cord blood transfusion 10 mL per kg for anemia Receives: Other: Blood transfusion |
| Allogeneic blood transfusion | Active comparator | Allogeneic blood transfusion 10 mL per kg for anemia Receives: Other: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion
Measured: one year
Secondary outcomes (6)
The hemoglobin levels at postnatal 14th days
Measured: 14 days
The hemoglobin levels at postnatal 28th days
Measured: 28 days
The hemoglobin levels at postnatal 35th days
Measured: 35 days
The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 36 weeks
Measured: 3 months
The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 40 weeks
Measured: 5 months
Developmental assessments of infants
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startMar 2009
- Primary completionSep 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of PrematurityStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Okulu, Ankara University
- Investigators
- Saadet Arsan, Professor, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101086
- Sponsor's protocol ID
- Ankara University-06
- Status last verified
- Mar 2014
- First submitted
- 28 Mar 2014
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Autologous Cord Blood Transfusions in Premature Infants
- ClinicalTrials.gov ID
- NCT02101086
- Acronym / sponsor ID
- Ankara University-06
- Conditions
- Anemia of Prematurity
- Keywords
- umbilical cord blood, premature, autologous transfusion, allogeneic transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Apr 2014 (estimated)
- 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 purpose of this study is to investigate the efficacy and safety of autologous cord blood transfusions in very-low-birth-weight premature infants, and to evaluate the developmental outcomes of the infants who received autologous transfusions.
Detailed description
Blood transfusions have many risks including transfusion reactions and infections. Cord blood is accepted as an alternative method for red cell transfusions in low-birth weight (LBW) premature newborns. However, experience and scientific evidence concerning in-vivo efficacy and safety of red blood cell (RBC) concentrates derived from cord blood in very LBW premature newborns is still insufficient.
A total of 50 umbilical cord blood (UCB) collected from infants born before 32 weeks' gestational age and processed into autologous RBC products. Infants requiring blood transfusion were randomly assigned to an autologous or allogeneic product. Two randomized groups were compared on the 14th, 28th, 35th days and >35th days with respect to hemoglobin levels, transfusion numbers, transfusion and phlebotomy volumes, and hemoglobin, reticulocyte counts and erythropoietin levels in the postconceptional 36th and 40th weeks' gestation, and hemoglobin levels at postnatal 6-months age. All transfused infants were developmentally assessed by the end of the postnatal first year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Cord Blood Transfusion | Experimental | Other: Blood transfusionAutologous cord blood transfusion 10 mL per kg for anemia |
| Allogeneic blood transfusion | Active comparator | Other: Blood transfusionAllogeneic blood transfusion 10 mL per kg for anemia |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants born at ≤ 32 weeks gestational age
- Parental consent
Key exclusion criteria (4 listed)
- rhesus incompatibility
- hydrops fetalis
- maternal viral or bacterial infections including suspected chorioamnionitis
- parental refuse
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 transfusionWhenever the infant indicated to receive transfusion, a blood product request was sent to the blood bank. This infant was randomly assigned to the autologous or the allogeneic product labeled for each patient at birth in the blood bank | Other | Allogeneic blood transfusion, Autologous Cord Blood Transfusion |
Primary outcome
Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion
Time frame: one year
6 secondary outcomes
The hemoglobin levels at postnatal 14th days
Time frame: 14 days
The hemoglobin levels at postnatal 28th days
Time frame: 28 days
The hemoglobin levels at postnatal 35th days
Time frame: 35 days
The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 36 weeks
Time frame: 3 months
The hemoglobin, erythropoietin and reticulocyte counts at postconceptional 40 weeks
Time frame: 5 months
Developmental assessments of infants
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
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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.
Saadet Arsan, Professor study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood transfusion in people with Anemia of Prematurity, run by Ankara University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 1 Apr 2014. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number and percentage of participants that receive autologous transfusion with a decrease in allogeneic transfusion (time frame: one year). 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 1 Apr 2014.