Age of Red blood cells In Premature Infants trial

Completed

Conditions: Premature infants weighing less than 1250 g admitted to the neonatal intensive care unit
Pregnancy and Childbirth
Prematurity

Registration Number: ISRCTN65939658

Lead Sponsor: Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 450

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome comprised of five major neonatal morbidities: <br>1. Necrotising enterocolitis<br>2. Retinopathy of prematurity<br>3. Bronchopulmonary dysplasia<br>4. Intraventricular hemorrhage<br>5. Mortality measured at 90 days

Secondary Outcome Measures

Name	Time	Method
1. Nosocomial infection<br>2. Individual rates of the morbidities comprising the primary outcome:<br>2.1. Necrotising enterocolitis<br>2.2. Retinopathy of prematurity<br>2.3. Bronchopulmonary dysplasia<br>2.4. Intraventricular hemorrhage<br>2.5. Death<br><br>Tertiary outcomes will include:<br>1. Length of mechanical ventilation<br>2. Length of stay in the NICU<br>3. Both minor and major interventions received while in the NIC