Age of Red blood cells In Premature Infants trial
| ISRCTN | ISRCTN65939658 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65939658 |
| ClinicalTrials.gov number | NCT00326924 |
| Secondary identifying numbers | MCT-75527 |
- Submission date
- 02/10/2006
- Registration date
- 02/10/2006
- Last edited
- 16/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dean A Fergusson
Scientific
Scientific
Clinical Epidemiology Program
Ottawa Hospital Research Institute
501 Smyth Road, Box 201
Ottawa
Ontario
K1H 8L6
Canada
| Phone | +1 613 737 8480 |
|---|---|
| dafergusson@ohri.ca |
Study information
| Study design | Multicentre, two arm, randomised parallel trial with study participant, investigator, caregiver, outcome assessor and data analyst blinded |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Age of Red blood cells In Premature Infants: a multicentre, two arm, randomised parallel trial |
| Study acronym | ARIPI |
| Study objectives | The transfusion of red blood cells (RBCs) stored for less than or equal to seven days will decrease the incidence of a 90-day composite measure consisting of all-cause mortality and organ dysfunction including bronchopulmonary dysplasia, necrotising enterocolitis, intraventricular haemorrhage and retinopathy of prematurity in premature infants weighing less than or equal to 1250 grams. |
| Ethics approval(s) | Research Ethics Board of The Ottawa Hospital, Ottawa, Ontario (Canada) approved on the 14th June 2006. |
| Health condition(s) or problem(s) studied | Premature infants weighing less than 1250 g admitted to the neonatal intensive care unit |
| Intervention | Experimental Group: transfusion of fresh blood stored less than or equal to seven days. Control Group: standard practice (blood stored up to 35 days). In all sites but Saskatoon, O-Rh negative RBCs will be divided into satellite units of between four and eight aliquots, and these aliquots will be removed from their satellite units as needed in order to reduce wastage. Dose as per standard care/duration: up to 90 days. |
| Intervention type | Other |
| Primary outcome measure | Composite outcome comprised of five major neonatal morbidities: 1. Necrotising enterocolitis 2. Retinopathy of prematurity 3. Bronchopulmonary dysplasia 4. Intraventricular hemorrhage 5. Mortality measured at 90 days |
| Secondary outcome measures | 1. Nosocomial infection 2. Individual rates of the morbidities comprising the primary outcome: 2.1. Necrotising enterocolitis 2.2. Retinopathy of prematurity 2.3. Bronchopulmonary dysplasia 2.4. Intraventricular hemorrhage 2.5. Death Tertiary outcomes will include: 1. Length of mechanical ventilation 2. Length of stay in the NICU 3. Both minor and major interventions received while in the NICU |
| Overall study start date | 01/05/2006 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 450 |
| Key inclusion criteria | 1. Requirement of a second allogeneic RBC transfusion for the treatment of prematurity 2. Infant age 0 - 27 days, either sex 3. Less than 1250 grams birth weight 4. Admitted to the participating Neonatal Intensive Care Unit (NICU) 5. Parents or guardian have signed (proxy) informed consent |
| Key exclusion criteria | 1. Infants whose first transfusion was older than seven days 2. Infants already given a second RBC transfusion 3. Infants scheduled to undergo an exchange transfusion 4. Infants that will receive directed donations 5. Infants that have rare blood types or difficulty with cross-matching 6. Infants whose proxy has refused consent 7. Infants who are moribund upon admission to the NICU or not expected to survive due to a severe congenital anomaly |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
Clinical Epidemiology Program
Ontario
K1H 8L6
Canada
K1H 8L6
Canada
Sponsor information
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Research organisation
Research organisation
725 Parkdale Avenue
Ottawa
Ontario
K1Y 4E9
Canada
| Phone | +1 613 761 4395 |
|---|---|
| info@ohri.ca | |
| Website | http://www.ohri.ca/ |
"ROR" |
https://ror.org/03c62dg59 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75527)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/01/2009 | Yes | No | |
| Results article | results | 10/10/2012 | Yes | No |
