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

TRAIN study: TRAnsfusion In Neonates and ideal red cell volume study - a randomised controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68861901

Enrollment

Registered

2014-01-31

Start date

2014-05-01

Completion date

Unknown

Last updated

2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfusion for anaemia of prematurity Neonatal Diseases

Interventions

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 ris

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 05/08/2014: 1. Evidence of active bleeding 2. 24-hour post surgical intervention 3. ABO/Rh incompatibility haemolysis 4. Disseminated Intravascular Coagulopathy 5. Intra-Ventricular Haemorrhage (IVH) grade III or more Previous exclusion criteria: 1. Evidence of bleeding 2. 24 h post surgical intervention 3. ABO/Rh incompatibility haemolysis and/or 4. Disseminated Intravascular Coagulopathy

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026