Premature BirthNCT00326924
Age of Red Blood Cells in Premature Infants Study (ARIPI)
A study testing Transfusion in people with Premature Birth, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome. Read more about this study
- Who is it for?
- Ages 1 minute to 37 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 377 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 minute to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- birthweight of less than 1250g
- admitted to participating NICU
- consent acquired from proxy for the patient
Who cannot join
- already received one or more transfusions
- requirement for an exchange transfusion
- will be receiving directed donations
- have rare blood types/difficult cross-match
- proxy has refused consent
- moribund on admission to NICU/expected to die
- mitigating child protection issues
Trial locations and contacts
1 site in 1 country.
About this study
To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.
- Conditions
- Premature Birth
- Being tested
- Transfusion
- Keywords
- Transfusion
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransfusionBiological
Also called non applicable
PRBC blood transfusions.
| Study group | Role | What they receive |
|---|---|---|
| Biological | Experimental | PRBCs that are less than 7 days old are considered 'fresh'. Receives: Biological: Transfusion |
| Standard PRBCs | Experimental | PRBCs 'stored' as per hospital policy. Receives: Biological: Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality
The primary outcome was a composite outcome composed of mortality and major neonatal morbidities associated with acute organ dysfunction or failure. In addition to death, the 4 major morbidities comprising the composite outcome were bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intraventricular hemorrhage.
Measured: 2 weeks, 4 weeks, 12 weeks, 90 days
Secondary outcomes (3)
Clinically Suspected Infection and Culturally Confirmed Infections
Infection was categorized as clinically suspected and positive cultures.
Measured: 90 days
Length of Stay
Length of Stay in neonatal intensive unit
Measured: until last participants left neonatal intensive care unit
Number of Participants Using Mechanical Ventilation.
Number of Participants using Mechanical Ventilation
Measured: whether a mechanical ventilation was used at any time point during 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean Fergusson, PhD, Study director, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326924
- Sponsor's protocol ID
- 2004706-01H
- Status last verified
- Jan 2018
- First submitted
- 15 May 2006
- Last updated
- 19 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.
PubMed 23874777Fergusson DA, Hebert P, Hogan DL, LeBel L, Rouvinez-Bouali N, Smyth JA, Sankaran K, Tinmouth A, Blajchman MA, Kovacs L, Lachance C, Lee S, Walker CR, Hutton B, Ducharme R, Balchin K, Ramsay T, Ford JC, Kakadekar A, Ramesh K, Shapiro S. Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: the ARIPI randomized trial. JAMA. 2012 Oct 10;308(14):1443-51. doi: 10.1001/2012.jama.11953.
PubMed 23045213Fergusson D, Hutton B, Hogan DL, LeBel L, Blajchman MA, Ford JC, Hebert P, Kakadekar A, Kovacs L, Lee S, Sankaran K, Shapiro S, Smyth JA, Ramesh K, Bouali NR, Tinmouth A, Walker R. The age of red blood cells in premature infants (ARIPI) randomized controlled trial: study design. Transfus Med Rev. 2009 Jan;23(1):55-61. doi: 10.1016/j.tmrv.2008.09.005.
PubMed 19056034
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age of Red Blood Cells in Premature Infants Study (ARIPI)
- ClinicalTrials.gov ID
- NCT00326924
- Acronym / sponsor ID
- 2004706-01H
- Conditions
- Premature Birth
- Keywords
- Transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 May 2006 (estimated)
- Results
- Posted 19 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological | Experimental | Biological: TransfusionPRBCs that are less than 7 days old are considered 'fresh'. |
| Standard PRBCs | Experimental | Biological: TransfusionPRBCs 'stored' as per hospital policy. |
Who may qualify
- Ages
- 1 minute to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- birthweight of less than 1250g
- admitted to participating NICU
- consent acquired from proxy for the patient
Key exclusion criteria (7 listed)
- already received one or more transfusions
- requirement for an exchange transfusion
- will be receiving directed donations
- have rare blood types/difficult cross-match
- proxy has refused consent
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 |
|---|---|---|
| TransfusionAlso: non applicablePRBC blood transfusions. | Biological | Biological, Standard PRBCs |
Primary outcome
1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality
Time frame: 2 weeks, 4 weeks, 12 weeks, 90 days
The primary outcome was a composite outcome composed of mortality and major neonatal morbidities associated with acute organ dysfunction or failure. In addition to death, the 4 major morbidities comprising the composite outcome were bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intraventricular hemorrhage.
3 secondary outcomes
Clinically Suspected Infection and Culturally Confirmed Infections
Time frame: 90 days
Length of Stay
Time frame: until last participants left neonatal intensive care unit
Number of Participants Using Mechanical Ventilation.
Time frame: whether a mechanical ventilation was used at any time point during 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23874777Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.
- Derived from this study: PubMed 23045213Fergusson DA, Hebert P, Hogan DL, LeBel L, Rouvinez-Bouali N, Smyth JA, Sankaran K, Tinmouth A, Blajchman MA, Kovacs L, Lachance C, Lee S, Walker CR, Hutton B, Ducharme R, Balchin K, Ramsay T, Ford JC, Kakadekar A, Ramesh K, Shapiro S. Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: the ARIPI randomized trial. JAMA. 2012 Oct 10;308(14):1443-51. doi: 10.1001/2012.jama.11953.
- Derived from this study: PubMed 19056034Fergusson D, Hutton B, Hogan DL, LeBel L, Blajchman MA, Ford JC, Hebert P, Kakadekar A, Kovacs L, Lee S, Sankaran K, Shapiro S, Smyth JA, Ramesh K, Bouali NR, Tinmouth A, Walker R. The age of red blood cells in premature infants (ARIPI) randomized controlled trial: study design. Transfus Med Rev. 2009 Jan;23(1):55-61. doi: 10.1016/j.tmrv.2008.09.005.
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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.
Dean Fergusson, PhD study director
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfusion in people with Premature Birth, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 3 inclusion and 7 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 19 Jan 2018. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 19 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality (time frame: 2 weeks, 4 weeks, 12 weeks, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00326924, which also lists 3 linked publications.
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 19 Jan 2018.