TRAIN study: TRAnsfusion In Neonates and ideal red cell volume study

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2014
INTERVENTION: Comparing standard method to calculate RBC volume to transfuse (10 ‐ 20ml/kg) to a formula that includes desired rise in Hb level (volume of packed cell transfused (ml) = 5 X weight (kg) X desired rise in Hb (g/dl)). The main outcome of the study is determine which method of calculating RBC transfusion volume is more likely to achieve the target Hb level. One arm will include neonates where volume is calculated using the standard method, which is based only on weight (ml/kg). The other arm will include neonates who receive a volume calculated using weight and desired rise in Hb. Duration of intervention is maximum 4 hours, which is the duration of transfusion. Neonates will be followed for a period of 2 weeks to determine the rise in Hb post transfusion and the need to re‐transfuse. CONDITION: Transfusion for anaemia of prematurity ; Neonatal Diseases PRIMARY OUTCOME: Current primary outcome measures as of 05/08/2014:; Reaching desired Haemoglobin level within 16 hours post transfusion; ; Previous primary outcome measures:; Hemoglobin/Hematocrit (Hb/HCT) rise within 24 hours post transfusion SECONDARY OUTCOME: Current secondary outcome measures as of 05/08/2014:; 1. Re‐transfusion within two weeks after the first transfusion; 2. Transfusion‐associated circulatory overload (TACO); 3. Use of diuretics during or post transfusion; 4. Oxygen requirement (before and after transfusion); 5. Incidence:; 5.1. Necrotising entero‐colitis (NEC); 5.2. Chronic lung disease (CLD); 5.3. Retinopathy of prematurity (ROP); 5.4. Peri‐ventricular leukomalacia (PVL); 5.5. Intra‐ventricular haemorrhage (IVH); 5.6. Bayley's scales of infant development at 2 years; 5.7. Mortality; ; Previous secondary outcome measures:; 1. Re‐transfusion within two weeks after the first transfusion; 2. Transfusion Associated Circulatory Overload (TACO) within 24 hours of transfusion; 3. Use of diuretics due to volume overload within 24 hours of transfusion; 4. Oxygen requirement pre and post transfusion within 24 hours using pulse oximeter INCLUSION CRITERIA: Current inclusion criteria as of 05/08/2014: 1. All infants admitted to NICU and requiring RBC transfusion for the first time 2. Born less than 32 weeks gestation Previous INCLUSION CRITERIA: All infants admitted to NICU and required RBC transfusion for the first time.
Epistemonikos ID: 9f004f4e58061e3b7dea623e32a497e7bc12545d
First added on: Aug 23, 2024