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**** DRAFT FOR PUBLIC CONSULTATION **** Technical report on neonatal and paediatric patient blood management Volume 1 – Review of the evidence August 2015

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**** DRAFT FOR PUBLIC CONSULTATION ****

References

Technical report on neonatal and paediatric patient blood management

Volume1 Review of the evidence

August 2015

**** DRAFT FOR PUBLIC CONSULTATION ****

**** DRAFT FOR PUBLIC CONSULTATION ****

Note

This volume presents the main body of evidence found by a systematic literature review on neonatal and paediatric patient blood management. Volume2 presents the related appendixes (AppendixA to AppendixF). These two volumes cover all research questions developed for this topic.

Contents

Abbreviations and acronymsxiv

1Introduction1

2Methods2

2.1Research question development2

2.1.1Foreground research questions3

2.1.2Background research questions4

2.1.3Aboriginal and Torres Strait Islander populations4

2.2Literature searches4

2.2.1Electronic databases4

2.2.2Manual searching of reference lists5

2.2.3Expert sources5

2.2.4Background question research5

2.2.5Issues relevant to Aboriginal and Torres Strait Islander peoples and culturally and linguistically diverse communities6

2.2.6Cost effectiveness6

2.3Inclusion and exclusion criteria6

2.4Classification and assessment of evidence7

2.4.1Quality appraisal9

2.4.2Data extraction9

2.5Assessment of the body of evidence and formulation of recommendations10

2.5.1Use of the modified NHMRC evidence statement form10

2.5.2Practice points13

2.6Limitations of the review methodology14

2.7Protocol deviation14

3Findings of systematic review15

3.1Question 115

3.1.1Background17

3.1.2Methods17

3.1.3Preterm and low birth weight infants19

3.1.4Infants, children and adolescents75

3.1.5Neonatal and paediatric patients with sickle cell disease77

3.1.6Neonatal and paediatric patients with cancer89

3.1.7Neonatal and paediatric patients with severe anaemia associated with malaria95

3.1.8Neonatal and paediatric patients requiring surgery103

3.1.9Critically ill neonatal and paediatric patients119

3.2Question 2139

3.2.1Background141

3.2.2Methods142

3.2.3Preterm and low birth weight infants143

3.2.4Infants, children and adolescents at risk of anaemia230

3.2.5Neonatal and paediatric patients with cancer253

3.2.6Neonatal and paediatric patients with kidney disease275

3.2.7Neonatal and paediatric patients with malaria288

3.2.8Neonatal and paediatric patients with HIV or AIDS298

3.2.9Neonatal and paediatric patients with sickle cell disease304

3.2.10Neonatal and paediatric patients requiring surgery321

3.2.11Critically ill neonatal and paediatric patients339

3.3Question 3349

3.3.1Background350

3.3.2Methods351

3.3.3Preterm and low birth weight infants352

3.3.4Neonatal and paediatric patients with cancer378

3.3.5Neonatal and paediatric patients undergoing surgery387

3.3.6Critically ill neonatal and paediatric patients424

3.4Question 4440

3.4.1Methods440

3.4.2Preterm and term infants441

3.4.3Neonatal and paediatric patients undergoing surgery477

3.4.4Critically ill neonatal and paediatric patients576

4Appendixes578

4.1Appendix 1 Research question structure578

4.2Appendix 2 Quality assessment585

4.2.1Systematic reviews586

4.2.2Randomised controlled trials587

4.2.3Cohort studies/ Concurrent control588

4.2.4Casecontrol studies589

4.3Appendix 3 Modified NHMRC evidence statement form590

4.3.1Evidence statement form590

4.3.2Recommendation form592

4.4Appendix 4 Consensus process for development of practice points593

4.4.1Background593

4.4.2Role of the Clinical/Consumer Reference Group593

4.4.3Chair of CRG meetings593

4.4.4Development of practice points: overview of consensus decision-making process594

4.4.5Guiding principles and values595

4.4.6Ground rules595

5References596

Tables

Table 2.1.1Phases of development of guideline modules1

Table 2.4.1NHMRC evidence hierarchy: designations of levels of evidence according to type of research question8

Table 2.4.2NHMRC dimensions of evidence9

Table 2.5.1Components of the evidence statement11

Table 2.5.2Body-of-evidence matrix12

Table 2.5.3Definitions of NHMRC grades for recommendations13

Table 3.1.1Characteristics and quality of Level III evidence identified in this review RBC transfusion versus no transfusion in preterm infants22

Table 3.1.2Characteristics and quality of Level III evidence identified by included systematic reviews RBC transfusion versus no transfusion in preterm infants25

Table 3.1.3Preterm infants: Results for RBC transfusion versus no transfusion (or alternate dose) Mortality28

Table 3.1.4Preterm infants: Results for RBC transfusion versus no transfusion (or alternate dose) Severe morbidity (NEC)33

Table 3.1.5Preterm infants: Results for RBC transfusion versus no transfusion (or alternate dose) Severe morbidity (ROP)42

Table 3.1.6Preterm infants: Results for RBC transfusion versus no transfusion (or alternate dose) Severe morbidity (brain injury on ultrasound)45

Table 3.1.7Characteristics and quality of Level I evidence - restrictive RBC transfusion versus liberal RBC transfusion47

Table 3.1.8Characteristics and quality of Level II evidence restrictive RBC transfusion versus liberal RBC transfusion48

Table 3.1.9Preterm infants: Results for restrictive RBC transfusion versus liberal RBC transfusion Mortality51

Table 3.1.10Preterm infants: Results for restrictive RBC transfusion versus liberal RBC transfusion Composite of mortality and severe morbidity (BPD, ROP, NEC, brainy injury)55

Table 3.1.11Preterm infants: Results for restrictive RBC transfusion versus liberal RBC transfusion Severe morbidity (BPD)59

Table 3.1.12Preterm infants: Results for restrictive RBC transfusion versus liberal RBC transfusion Severe morbidity (NEC)61

Table 3.1.13Preterm infants: Results for restrictive RBC transfusion versus liberal RBC transfusion Severe morbidity (ROP)64

Table 3.1.14Preterm infants: results for restrictive RBC transfusion versus liberal RBC transfusion Severe morbidity (brain injury on ultrasound)67

Table 3.1.15Preterm infants: results for restrictive RBC transfusion versus liberal RBC transfusion Neurodevelopmental disability70

Table 3.1.16Preterm infants: Results for restrictive RBC transfusion versus liberal RBC transfusion Transfusion-related serious adverse events74

Table 3.1.17Characteristics and quality of Level I evidence RBC transfusion versus no transfusion (or alternate dose) in paediatric patients with sickle cell disease78

Table 3.1.18Characteristics and quality of Level II evidence - RBC transfusion versus no transfusion (or alternate dose) in paediatric patients with sickle cell disease79

Table 3.1.19Paediatric patients with sickle cell disease: Results for RBC transfusion versus no transfusion (or alternate dose) Mortality82

Table 3.1.20Paediatric patients with sickle cell disease: RBC transfusion versus no transfusion (or alternate dose) Stroke84

Table 3.1.21Paediatric patients with sickle cell disease: RBC transfusion versus no transfusion (or alternate dose) Transfusion-related serious adverse events87

Table 3.1.22Characteristics and quality of Level III evidence RBC transfusion versus no transfusion in paediatric patients with cancer91

Table 3.1.23Neonatal and paediatric patients with cancer: Results for RBC transfusion versus no transfusion (or alternate dose) Mortality93

Table 3.1.24Characteristics and quality of Level I evidence RBC transfusion versus no transfusion (or alternate dose) in paediatric patients with malaria96

Table 3.1.25Characteristics and quality of Level II evidence RBC transfusion versus no transfusion (or alternate dose) in paediatric patients with malaria97

Table 3.1.26Paediatric patients with malaria: Results for RBC transfusion versus no transfusion (or alternate dose) Mortality99

Table 3.1.27Paediatric patients with malaria: Results for RBC transfusion versus no transfusion (or alternate dose) Transfusion-related serious adverse events101

Table 3.1.28Characteristics and quality of Level III evidence RBC transfusion versus no transfusion (or alternate dose) in paediatric patients requiring surgery106

Table 3.1.29Neonatal and/or paediatric patients requiring surgery: Results for RBC transfusion versus no transfusion (or alternate dose) Mortality108

Table 3.1.30Characteristics and quality of Level I evidence - restrictive RBC transfusion versus liberal RBC transfusion in neonatal and/or paediatric patients requiring surgery110

Table 3.1.31Characteristics and quality of Level II evidence - restrictive RBC transfusion versus liberal RBC transfusion in neonatal and/or paediatric patients requiring surgery111

Table 3.1.32Neonatal and/or paediatric patients requiring surgery: Results for restrictive RBC transfusion versus liberal RBC transfusion Mortality113

Table 3.1.33Neonatal and/or paediatric patients requiring surgery: Results for restrictive RBC transfusion versus liberal RBC transfusion New or progressive MODs115

Table 3.1.34Paediatric patients requiring surgery: Results for restrictive RBC transfusion versus liberal RBC transfusion Transfusion-related serious adverse events118

Table 3.1.35Characteristics and quality of Level III evidenc