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Age of Red Blood Cells in Premature Infants Study (ARIPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00326924
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Premature Birth
Intervention: Biological: Transfusion

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Biological

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

Transfusion: PRBC blood transfusions.

Standard PRBCs

PRBCs 'stored' as per hospital policy.

Transfusion: PRBC blood transfusions.


Participant Flow:   Overall Study
    Biological   Standard PRBCs
STARTED   188   189 
COMPLETED   187   188 
NOT COMPLETED   1   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biological

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

Transfusion: PRBC blood transfusions.

Standard PRBCs

PRBCs 'stored' as per hospital policy.

Transfusion: PRBC blood transfusions.

Total Total of all reporting groups

Baseline Measures
   Biological   Standard PRBCs   Total 
Overall Participants Analyzed 
[Units: Participants]
 188   189   377 
Age 
[Units: Days]
Mean (Standard Deviation)
 10.0  (9.7)   9.9  (9.5)   10  (9.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      79  42.0%      95  50.3%      174  46.2% 
Male      109  58.0%      94  49.7%      203  53.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Mothers' characteristics       
White      138  73.4%      123  65.1%      261  69.2% 
Black      17   9.0%      24  12.7%      41  10.9% 
Latin American      4   2.1%      1   0.5%      5   1.3% 
Asian      6   3.2%      8   4.2%      14   3.7% 
Aboriginal      10   5.3%      20  10.6%      30   8.0% 
Filipino      0   0.0%      4   2.1%      4   1.1% 
Arab      3   1.6%      1   0.5%      4   1.1% 
Other or unknown      10   5.3%      8   4.2%      18   4.8% 
Region of Enrollment 
[Units: Participants]
     
Canada   188   189   377 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Clinically Suspected Infection and Culturally Confirmed Infections   [ Time Frame: 90 days ]

3.  Secondary:   Length of Stay   [ Time Frame: until last participants left neonatal intensive care unit ]

4.  Secondary:   Number of Participants Using Mechanical Ventilation.   [ Time Frame: whether a mechanical ventilation was used at any time point during 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dean Fergusson, Senior Scientist
Organization: Ottawa Hospital Research Institute
phone: 613-737-8480
e-mail: dafergusson@ohri.ca


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00326924     History of Changes
Other Study ID Numbers: 2004706-01H
First Submitted: May 15, 2006
First Posted: May 17, 2006
Results First Submitted: March 13, 2017
Results First Posted: January 19, 2018
Last Update Posted: January 19, 2018