NCT00326924

Brief Summary

To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
377

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

January 19, 2018

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

6.1 years

First QC Date

May 15, 2006

Results QC Date

March 13, 2017

Last Update Submit

January 17, 2018

Conditions

Premature Birth

Keywords

Transfusion

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks, 4 weeks, 12 weeks, 90 days

Secondary Outcomes (3)

  • Clinically Suspected Infection and Culturally Confirmed Infections

    90 days

  • Length of Stay

    until last participants left neonatal intensive care unit

  • Number of Participants Using Mechanical Ventilation.

    whether a mechanical ventilation was used at any time point during 90 days

Study Arms (2)

Biological

EXPERIMENTAL

PRBCs that are less than 7 days old are considered 'fresh'.

Biological: Transfusion

Standard PRBCs

EXPERIMENTAL

PRBCs 'stored' as per hospital policy.

Biological: Transfusion

Interventions

TransfusionBIOLOGICAL

PRBC blood transfusions.

Also known as: non applicable
BiologicalStandard PRBCs

Eligibility Criteria

Age1 Minute - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • birthweight of less than 1250g
  • admitted to participating NICU
  • consent acquired from proxy for the patient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (3)

  • 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.

    PMID: 23874777DERIVED

  • Fergusson 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.

    PMID: 23045213DERIVED

  • Fergusson 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.

    PMID: 19056034DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Results Point of Contact

Title
Dean Fergusson, Senior Scientist
Organization
Ottawa Hospital Research Institute
dafergusson@ohri.ca
613-737-8480

Study Officials

  • Dean Fergusson, PhD

    OHRI

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

May 1, 2006

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

January 19, 2018

Results First Posted

January 19, 2018

Record last verified: 2018-01

Locations

CA(1)