143. Treatment Of Acute Malnutrition In Childhood

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143. Treatment Of Acute Malnutrition In Childhood

 

 

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Declaration ………………………………………………………………………………………………. 3
Abstract …………………………………………………………………………………………………….. 4
Abbreviations & acronyms ………………………………………………………………….. 5
Tables ………………………………………………………………………………………………………. 12
Figures …………………………………………………………………………………………………….. 14
Boxes ……………………………………………………………………………………………………….. 15
Pictures …………………………………………………………………………………………………… 15
Acknowledgements ……………………………………………………………………………… 16
Foreword …………………………………………………………………………………………………….. 17
Thesis outline …………………………………………………………………………………………….. 17
Role of the investigator ……………………………………………………………………………… 18
Chapter 1 ……………………………………………………………………………………………………. 19
Severe acute malnutrition – background …………………………………………. 19
1.1 global epidemiology and impact of malnutrition …………………………. 19
1.2 case definitions of severe acute malnutrition ……………………………… 21
1.2.1 ‘classical’ who definition ………………………………………………………….. 21
1.2.2 ‘modified’ definition – complicated and uncomplicated sam ………. 21
1.2.3 mid-upper arm circumference ………………………………………………………. 22
1.2.4 world health organization child growth standards(21) ……………… 22
1.2.5 case definition of sam used in this thesis …………………………………… 23
1.2.6 why case definition matters ………………………………………………………… 23
1.3 treatment programmes for childhood sam ………………………………….. 24
1.3.1 conceptual frameworks and root causes ……………………………………… 24
1.3.2 the pathophysiology of sam ………………………………………………………. 25
1.3.3 therapeutic & supplementary feeding programmes (tfp & sfp) .. 27
1.3.4 inpatient tfps – therapeutic feeding centres ( nutritional
Rehabilitation units) ……………………………………………………………………………… 28
1.3.5 community management of acute malnutrition (cmam) ………….. 30
1.4 rutf (ready-to-use therapeutic foods) ……………………………………….. 31
1.4.1 history & development of ‘standard’, peanut-based rutf ………… 31
1.4.2 the potential role of alternative recipe rutf………………………………. 32
1.4.3 a note on rutf (ready-to-use therapeutic food) & lns (lipid
Nutrient supplement) terminology …………………………………………………………. 32
1.5 evidence gaps towards improved feeding programme impact ………. 33
1.5.1 what is the true public health impact of a tfp? ………………………….. 33
1.5.2 can poor outcomes in an hiv prevalent setting be improved? …….. 34
1.5.3 is there potential for rutf enhanced by functional food to improve
Tfp outcomes? ………………………………………………………………………………………… 34

Chapter 2 …………………………………………………………………………37
Aims & objectives …………………………………………………………………………………… 37
2.1 hypotheses ……………………………………………………………………………………… 37
2.2.1 study 1 – pronut (pre and probiotics in the treatment of severe
Acute malnutrition) ………………………………………………………………………………. 38
2.2.2 study 2 – fusam (long term follow-up after an episode of
Severe acute malnutrition) …………………………………………………………………….. 38

Chapter 3 ……………………………………………………………………………………………………. 39
Setting, participants & methods …………………………………………………………. 39
3.1 setting ……………………………………………………………………………………………… 39
3.1.1 malawi, the warm (but malnourished) heart of africa ………………… 39
3.1.2 therapeutic feeding programmes in malawi ……………………………….. 40
3.1.3 moyo nutrition ward, department of paediatrics, queen elizabeth
Central hospital, college of medicine, blantyre. ……………………………………. 41
3.2 study participants: the moyo case definition of sam …………………. 42
3.3 study participants: the moyo patient care pathway …………………….. 43
3.3.1 admission routes to moyo …………………………………………………………. 43
3.3.2 initial assessment and treatment in moyo (including
Anthropometry) ………………………………………………………………………………………. 43
3.3.3 inpatient treatment ……………………………………………………………………… 44
3.3.4 otp (outpatient) treatment ………………………………………………………… 45
3.3.5 discharge from moyo tfp …………………………………………………………. 46
3.3.6 hiv & cd4 testing ……………………………………………………………………….. 46
3.3.7 hiv treatment ………………………………………………………………………………. 47
3.3.8 other tfp-related services: sfp, tb, disability …………………………… 47
3.3.9 patient flow summary & cohorts enrolled in pronut & fusam 47
3.4 methods: quality control systems …………………………………………………… 49
3.4.1 anthropometry …………………………………………………………………………….. 49
3.4.2 patient records systems ……………………………………………………………….. 51
3.4.3 patient held records ……………………………………………………………………… 52
3.4.4 staff training and supervision ……………………………………………………… 52
3.5 methods: the ‘verbal map’ and patient follow-up ………………………….. 53
3.6 ethical approval ……………………………………………………………………………… 54

Chapter 4 ……………………………………………………………………………………………………. 55
‘pronut’ study ………………………………………………………………………………………… 55
4.1 aim ………………………………………………………………………………………………….. 55
4.1.1 objectives: ……………………………………………………………………………………. 55
4.2 methods ………………………………………………………………………………………….. 56
4.2.1 study design …………………………………………………………………………………. 56
4.2.2 setting & participants ………………………………………………………………….. 56
4.2.3 interventions ………………………………………………………………………………… 56
4.2.4 trial safety & sepsis monitoring …………………………………………………. 58
4.2.5 outcome variables ……………………………………………………………………….. 60
4.2.6 sample size …………………………………………………………………………………… 60
4.2.8 blinding ……………………………………………………………………………………….. 61
4.2.9 statistical methods & data handling …………………………………………… 62
4.3 results ………………………………………………………………………………………… 63
4.3.1 study flow chart …………………………………………………………………………… 63
4.3.2 patient characteristics at baseline ……………………………………………….. 64
4.3.3 main outcomes – programme cure and mortality …………………………. 65
4.3.4 secondary outcomes – carer reported clinical symptoms ……………… 69
4.3.5 kaplan-meier time-to-death analysis ………………………………………….. 71
4.3.6 subgroup analyses ……………………………………………………………………….. 72

Chapter 5 ……………………………………………………………………………………………………. 73
‘fusam’ study …………………………………………………………………………………………… 73
5.1 aims ………………………………………………………………………………………………… 73
5.1.1 objectives: ……………………………………………………………………………………. 73
5.2 methods ………………………………………………………………………………………….. 74
5.2.1 study design …………………………………………………………………………………. 74
5.2.2 setting & participants ………………………………………………………………….. 74
5.2.3 outcome variables ……………………………………………………………………….. 74
5.2.4 data sources and measurement ……………………………………………………. 76
5.2.5 bias ………………………………………………………………………………………………. 77
5.2.6 study size …………………………………………………………………………………….. 79
5.2.7 quantitative variables …………………………………………………………………. 79
5.2.8 statistical methods ………………………………………………………………………. 79
5.2.9 ethics ……………………………………………………………………………………………. 81
5.3 results – study flow chart and summary outcomes ……………………….. 82
5.3.1 fusam summary – total survivors ……………………………………………… 83
5.3.2 fusam summary – total mortality ……………………………………………… 83
5.3.3 fusam summary – total unknown final outcome ………………………. 83
5.4 results – baseline patient profile at admission to moyo …………….. 84
5.4.1 age & sex profile ………………………………………………………………………….. 84
5.4.2 nutritional profile ……………………………………………………………………….. 85
5.4.3 malnutrition severity (weight-for-height, weight-for-age and
Height-for-age z-scores) …………………………………………………………………………… 86
5.4.4 hiv related profile ……………………………………………………………………….. 87
5.4.5 clinical profile ………………………………………………………………………………… 88
5.4.6 past medical history ……………………………………………………………………….. 89
5.4.7 family and socioeconomic status ………………………………………………… 90
5.5 what explains mortality or survival? Kaplan-meier failure curves and
Cox regression …………………………………………………………………………………………….. 92
5.5.1 kaplan-meier failure curve – all patients …………………………………….. 92
5.5.2 kaplan-meier failure curves – by hiv ………………………………………….. 93
5.5.3 what explains adverse sam outcomes – malnutrition severity? …. 94
5.5.4 what explains adverse sam outcomes – hiv status? ………………….. 97
5.5.5 what explains adverse sam outcomes – baseline clinical severity of
Illness? ………………………………………………. 98
5.5.6 what explains adverse sam outcomes – risk factors in past medical
History? ………………………………………………….. 100
5.5.7 what explains adverse sam outcomes – family and socioeconomic
Risk factors? …………………………………………………………………………………………… 101
5.6 results – profile of children found at long term fusam follow-up
5.6.1 recurrence of malnutrition …………………………………………………………. 105
5.6.2 clinical progress since discharge ………………………………………………… 106
5.6.3 access to supplementary feeding following discharge …………….. 107
5.6.4 access to tb services ………………………………………………………………….. 108
5.6.5 access to hiv services ………………………………………………………………… 109
5.6.6 tfp-based nutrition education sessions: do they improve knowledge
Or affect mortality? ……………………………………………………………………………….. 112
5.7 results – growth catch-up in the ex-sam child …………………………… 114
5.7.1 overall z-score changes during treatment ………………………………….. 114
5.7.2 z-score changes during treatment, by hiv status and admission
Diagnosis ……………………………………………………………………………………………….. 116
5.7.3 weight-for-height changes during treatment ………………………….. 119
5.7.4 weight-for-age changes during treatment…………………………………… 120
5.7.5 height-for-age changes during treatment …………………………………… 121
5.8 results – growth catch-up compared to sibling controls ……………… 122
5.8.1 weight-for-height, weight-for-age and height-for-age compared to
Sib controls ……………………… 122
5.8.2 weight-for-height compared to sib controls, by birth order ………. 123
5.8.3 weight-for-age compared to sib controls, by birth order …………… 124
5.8.4 height-for-age compared to sib controls, by birth order ……………. 125
Chapter 6 ……………………………………………………………………. 126
Discussion …………………………………………………………………………………………….. 126
6.1 pronut ……………………………………………………………………………………….. 126
6.1.1 key findings ……………………………………………………………………………….. 126
6.1.2 strengths and weaknesses ………………………………………………………….. 126
6.1.3 meaning of the study and implications for future policy and
Research …………………………………………………………………………………………………. 130
6.2 fusam ………………………………………………………………………………………….. 131
6.2.1 key findings ……………………………………………………………………………….. 131
6.2.2 strengths and weaknesses ………………………………………………………….. 132
6.2.3 meaning of the study: generalizability ……………………………………….. 133
6.2.4 comparison with other related studies ………………………………………. 134
6.2.5 implications for policy and practice …………………………………………… 135
6.2.6 unanswered questions and future research ………………………………… 137

Chapter 7 ………………………………………………………………………………………………….. 139
Conclusions ………………………………………………………………………………………… 139
References …………………………………………………………………………………………… 140
Appendices ……………………………………………………………………………………………. 147
Annex a. Research articles – summary list ………………………………… 147
A.1 directly related to thesis ………………………………………………………. 147
A.2 related to theme of severe acute malnutrition …………….. 147
Annex b. Presentations to meetings – summary ………………………. 148

B.1 policy & general meetings (directly & indirectly phd-
Related) ………………………………………….. 148

B.2 academic meetings (directly and indirectly related to
Phd) 148
Annex c. Ethical approvals and patient consent forms ………….. 151
C.1 pronut ethical approval ……………………………………………………… 151
C.1.1 original …………………………………………………………………………………. 151
C.1.2 update ………………………………………………………………………………….. 152
C.2 informed voluntary consent form (english) ……………………… 153
C.3 informed voluntary consent form (chichewa) ………………… 154
C.4 fusam ethical approval form ………………………………………………. 155
Annex d. Moyo ward forms and protocols …………………………………. 156
D.1 weight chart ………………………………………………………………………………. 156
D.2 drug and inpatient symptom chart …………………………………….. 157
D.3 protocol for assessing inpatient symptoms and appetite………..158
D.4 inpatient ‘phased feeding’ protocol …………………………………… 159
D.5 otp protocols ……………………………………………………………………………. 166
Annex e. Pronut study forms and questionnaires …………………. 170
E.1 recruitment and consent ……………………………………………………… 170
E.2 baseline anthropometry ………………………………………………………… 171
E.3 baseline clinical profile …………………………………………………………. 172
E.4 baseline geographical details and verbal map ………………. 176
E.5 socioeconomic profile ……………………………………………………………. 179
E.6 otp review …………………………………………………………………………………. 181

Annex f. Pronut study additional details and results …………. 183
F.1 rutf quality control: concentration of synbiotic
Organisms ……………………………………………………………………………………………… 183
F.2 possible probiotic sepsis laboratory protocol ………………… 184
F.3 baseline clinical characteristics (detailed) …………………….. 185
F.4 baseline family and socioeconomic status (detailed) …. 186
Annex g. Fusam study forms and questionnaires ……………………. 187
G.1 main study form ………………………………………………………………………… 187
G.2 anthropometry (including sibling anthropometry and
Clinical status) …………………………………………………………………………………….. 191
G.3 hiv status and testing ……………………………………………………………. 192
Annex h fusam study additional details and results ……………. 193
H.1 baseline patient profile at admission to moyo……………… 193
H.1.1 subtype of wasting …………………………………………………………… 193
H.1.2 malnutrition severity at admission – details …………….. 194
H.1.3 hiv profile …………………………………………………………………………… 195
H.1.4 clinical profile ……………………………………………………………………. 196
H.1.5 past medical history ………………………………………………………… 197
H.1.6 family profile ……………………………………………………………………… 198
H.1.7 socioeconomic profile …………………………………………………….. 199
Annex I. Research article – pronut study, the lancet, 2009
200
Annex j. Research article – hiv and sam, malawi medical
Journal 2009 ……………………………………………………………………………………………. 209
Annex k. Research article – moyo chart, tropical doctor,
2009 215
K.1 original description of moyo chart …………………………………… 215
K.2 latest version of the moyo chart, as field tested in
Ethiopia, 2009 ……………………………………………………………………………………… 219

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