N/A
N=377
Age of Red Blood Cells in Premature Infants Study (ARIPI)
Premature Birth
Bottom Line
View on ClinicalTrials.gov: NCT00326924 ↗Enrolled (actual)
377
Serious AEs
0.3%
Results posted
Jan 2018
Primary outcome: Primary: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality — 99; 100 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transfusion (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality |
99; 100 | — |
| SECONDARY Clinically Suspected Infection and Culturally Confirmed Infections |
146; 146 | — |
| SECONDARY Length of Stay |
84; 77 | — |
| SECONDARY Number of Participants Using Mechanical Ventilation. |
151; 153 | — |
Summary
To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.
Eligibility Criteria
Inclusion Criteria
- birthweight of less than 1250g
- admitted to participating NICU
- consent acquired from proxy for the patient
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00326924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.