Age of Red blood cells In Premature Infants trial

ISRCTN	ISRCTN65939658
DOI	https://doi.org/10.1186/ISRCTN65939658
ClinicalTrials.gov (NCT)	NCT00326924
Protocol serial number	MCT-75527
Sponsor	Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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

Clinical Epidemiology Program
Ottawa Hospital Research Institute
501 Smyth Road, Box 201
Ottawa
Ontario
K1H 8L6
Canada

Phone	+1 613 737 8480
Email	dafergusson@ohri.ca

Study information

Primary study design	Interventional
Study design	Multicentre, two arm, randomised parallel trial with study participant, investigator, caregiver, outcome assessor and data analyst blinded
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/10/2012		Yes	No
Protocol article	protocol	01/01/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes