Transfusion and Treatment of severe anaemia in African children (TRACT): A study protocol for a randomised controlled trial

Trials

Volumn 16, Issue 1, 2015, Pages

  Mpoya, Ayub ^a   Kiguli, Sarah ^b   Olupot Olupot, Peter ^a   Opoka, Robert O ^b   Engoru, Charles ^c   Mallewa, Macpherson ^d   Chimalizeni, Yami ^d   Kennedy, Neil ^d   Kyeyune, Dorothy ^e   Wabwire, Benjamin ^f   M'baya, Bridon ^g   Bates, Imelda ^h,i   Urban, Britta ^h,i   von Hensbroek, Michael Boele ^j   Heyderman, Robert ^h,k   Thomason, Margaret J ^l   Uyoga, Sophie ^a   Williams, Thomas N ^a,m   Gibb, Diana M ^l   George, Elizabeth C ^l   Walker, A Sarah ^l   Maitland, Kathryn ^a,m   more..

^a Mulago Hospital ^*  (Uganda)

^b MAKERERE UNIVERSITY   (Uganda)

^c Soroti Regional Referral Hospital   (Uganda)

^d UNIVERSITY OF MALAWI   (Malawi)

^e Uganda National Blood Transfusion Service   (Uganda)

^f Mbale Regional Blood Bank   (Uganda)

^g Malawi Blood Transfusion Service   (Malawi)

^h Liverpool School of Tropical Medicine ^*  (Malawi)

ⁱ LIVERPOOL SCHOOL OF TROPICAL MEDICINE   (United Kingdom)

^j ACADEMIC MEDICAL CENTER   (Netherlands)

^k UNIVERSITY COLLEGE LONDON   (United Kingdom)

^l MRC CLINICAL TRIALS UNIT   (United Kingdom)

^m WELLCOME TRUST SANGER INSTITUTE   (United Kingdom)

more..

Author keywords

Africa; Anaemia; Antibiotic prophylaxis; Children; Emergency medicine; Haemoglobinopathies; Malaria; Micronutrients; Sepsis; Transfusion

Indexed keywords

ANTHELMINTIC AGENT; COTRIMOXAZOLE; FOLIC ACID; IRON; BIOLOGICAL MARKER; HEMOGLOBIN; VITAMIN;

ANEMIA; ANTIBIOTIC PROPHYLAXIS; ARTICLE; BLOOD TRANSFUSION; CHILD; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DISEASE SEVERITY; FOLLOW UP; HOSPITAL ADMISSION; HUMAN; INFANT; MAJOR CLINICAL STUDY; MALAWI; MINERAL SUPPLEMENTATION; MORBIDITY; MORTALITY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PATIENT SAFETY; RANDOMIZED CONTROLLED TRIAL; SURVIVAL; UGANDA; VITAMIN SUPPLEMENTATION; ADVERSE EFFECTS; AGE; BLOOD; CHILDHOOD MORTALITY; CLINICAL PROTOCOL; CLINICAL TRIAL; DIETARY SUPPLEMENT; DRUG ADMINISTRATION; HEALTH STATUS; HOSPITAL MORTALITY; INFANT MORTALITY; METABOLISM; METHODOLOGY; NUTRITIONAL STATUS; PRESCHOOL CHILD; RECURRENT DISEASE; RISK FACTOR; SEVERITY OF ILLNESS INDEX; TIME FACTOR; TREATMENT OUTCOME;

AGE FACTORS; ANEMIA; ANTHELMINTICS; BIOMARKERS; BLOOD TRANSFUSION; CHILD; CHILD MORTALITY; CHILD, PRESCHOOL; CLINICAL PROTOCOLS; DIETARY SUPPLEMENTS; DRUG ADMINISTRATION SCHEDULE; HEALTH STATUS; HEMOGLOBINS; HOSPITAL MORTALITY; HUMANS; INFANT; INFANT MORTALITY; MALAWI; NUTRITIONAL STATUS; PATIENT ADMISSION; RECURRENCE; RESEARCH DESIGN; RISK FACTORS; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME; TRIMETHOPRIM, SULFAMETHOXAZOLE DRUG COMBINATION; UGANDA; VITAMINS;

EID: 84953379176     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-1112-4     Document Type: Article

References (44)

1. McLean E, Cogswell M, Egli I, Wojdyla D, de Benoist B. Worldwide prevalence of anaemia, WHO Vitamin and Mineral Nutrition Information System, 1993-2005. Public health nutrition. 2009;12(4):444-54.
2. World malaria report 2014. Geneva, Switzerland: World Health Organization, 2014
3. Pocket book of hospital care for children. Guidelines for the management of common childhood illnesses. 2nd ed. Geneva: World Health Organization; 2013.
4. Kiguli S, Maitland K, George EC, Olupot-Olupot P, Opoka RO, Engoru C, et al. Anaemia and blood transfusion in African children presenting to hospital with severe febrile illness. BMC Med. 2015;13(1):21.
5. Brabin BJ, Premji Z, Verhoeff F. An analysis of anemia and child mortality. J Nutr. 2001;131(2S-2):636S-45S. discussion 46S-48S.
6. Phiri KS, Calis JC, Faragher B, Nkhoma E, Ng'oma K, Mangochi B, et al. Long term outcome of severe anaemia in Malawian children. PLoS One. 2008;3(8):e2903.
7. Calis JC, Phiri KS, Faragher EB, Brabin BJ, Bates I, Cuevas LE, et al. Severe anemia in Malawian children. N Engl J Med. 2008;358(9):888-99.
8. Meremikwu M, Smith HJ. Blood transfusion for treating malarial anaemia. Cochrane Database Syst Rev. 2000;2:CD001475.
9. Management of the child with a serious infection or severe malnutrition: guidelines for care at the first-referral level in developing countries. Geneva: WHO: World Health Organization, 2000.
10. Holzer BR, Egger M, Teuscher T, Koch S, Mboya DM, Smith GD. Childhood anemia in Africa: to transfuse or not transfuse? Acta Trop. 1993;55(1-2):47-51.
11. Bojang KA, Palmer A, Boele van Hensbroek M, Banya WA, Greenwood BM. Management of severe malarial anaemia in Gambian children. Trans R Soc Trop Med Hyg. 1997;91(5):557-61.
12. English M, Ahmed M, Ngando C, Berkley J, Ross A. Blood transfusion for severe anaemia in children in a Kenyan hospital. Lancet. 2002;359(9305):494-5.
13. Lackritz EM, Campbell CC, Ruebush 2nd TK, Hightower AW, Wakube W, Steketee RW, et al. Effect of blood transfusion on survival among children in a Kenyan hospital. Lancet. 1992;340(8818):524-8.
14. Bojang KA, Van Hensbroek MB, Palmer A, Banya WA, Jaffar S, Greenwood BM. Predictors of mortality in Gambian children with severe malaria anaemia. Ann Trop Paediatr. 1997;17(4):355-9.
15. Ernest SK, Anunobi NE, Adeniyi A. Correlates of emergency response interval and mortality from severe anaemia in childhood. West Afr J Med. 2002;21(3):177-9.
16. Maitland K, Kiguli S, Opoka RO, Engoru C, Olupot-Olupot P, Akech SO, et al. Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011;364(26):2483-95.
17. Marsh K, Forster D, Waruiru C, Mwangi I, Winstanley M, Marsh V, et al. Indicators of life-threatening malaria in African children. N Engl J Med. 1995;332(21):1399-404.
18. Pedro R, Akech S, Maitland K. Changing trends in blood transfusion in children and neonates admitted in Kilifi District Hospital, Kenya. Malar J. 2010;9(1):307.
19. Hospital Care for Children: guidelines for the management of common illnesses with limited resources. Geneva, Switzerland: World Health Organization, 2005. ISBN 92 4 154670 0.
20. Walker RH. Mathematical calculations in transfusion medicine. Clin Lab Med. 1996;16(4):895-906.
21. Abdalla SH. Iron and folate status in Gambian children with malaria. Ann Trop Paediatr. 1990;10(3):265-72.
22. van Hensbroek MB, Morris-Jones S, Meisner S, Jaffar S, Bayo L, Dackour R, et al. Iron, but not folic acid, combined with effective antimalarial therapy promotes haematological recovery in African children after acute falciparum malaria. Trans R Soc Trop Med Hyg. 1995;89(6):672-6.
23. Sazawal S, Black RE, Ramsan M, Chwaya HM, Stoltzfus RJ, Dutta A, et al. Effects of routine prophylactic supplementation with iron and folic acid on admission to hospital and mortality in preschool children in a high malaria transmission setting: community-based, randomised, placebo-controlled trial. Lancet. 2006;367(9505):133-43.
24. Northrop-Clewes CA, Thurnham DI. Biomarkers for the differentiation of anemia and their clinical usefulness. J Blood Med. 2013;4:11-22.
25. Phiri KS, Calis JC, Siyasiya A, Bates I, Brabin B, van Hensbroek MB. New cut-off values for ferritin and soluble transferrin receptor for the assessment of iron deficiency in children in a high infection pressure area. J Clin Pathol. 2009;62(12):1103-6.
26. Schauer C, Zlotkin S. Home fortification with micronutrient sprinkles - A new approach for the prevention and treatment of nutritional anemias. Paediatrics Child Health. 2003;8(2):87-90.
27. Christofides A, Schauer C, Sharieff W, Zlotkin SH. Acceptability of micronutrient sprinkles: a new food-based approach for delivering iron to First Nations and Inuit children in Northern Canada. Chronic Dis Can. 2005;26(4):114-20.
28. Chintu C, Bhat GJ, Walker AS, Mulenga V, Sinyinza F, Lishimpi K, et al. Co-trimoxazole as prophylaxis against opportunistic infections in HIV-infected Zambian children (CHAP): a double-blind randomised placebo-controlled trial. Lancet. 2004;364(9448):1865-71.
29. Mulenga V, Ford D, Walker AS, Mwenya D, Mwansa J, Sinyinza F, et al. Effect of cotrimoxazole on causes of death, hospital admissions and antibiotic use in HIV-infected children. Aids. 2007;21(1):77-84.
30. Walker AS, Ford D, Gilks CF, Munderi P, Ssali F, Reid A, et al. Daily co-trimoxazole prophylaxis in severely immunosuppressed HIV-infected adults in Africa started on combination antiretroviral therapy: an observational analysis of the DART cohort. Lancet. 2010;375(9722):1278-86.
31. Mwenya DM, Charalambous BM, Phillips PP, Mwansa JC, Batt SL, Nunn AJ, et al. Impact of cotrimoxazole on carriage and antibiotic resistance of Streptococcus pneumoniae and Haemophilus influenzae in HIV-infected children in Zambia. Antimicrob Agents Chemother. 2010;54(9):3756-62.
32. Thera MA, Sehdev PS, Coulibaly D, Traore K, Garba MN, Cissoko Y, et al. Impact of trimethoprim-sulfamethoxazole prophylaxis on falciparum malaria infection and disease. J Infect Dis. 2005;192(10):1823-9.
33. Arinaitwe E, Gasasira A, Verret W, Homsy J, Wanzira H, Kakuru A, et al. The association between malnutrition and the incidence of malaria among young HIV-infected and -uninfected Ugandan children: a prospective study. Malar J. 2012;11:90.
34. Adu-Afarwuah S, Lartey A, Brown KH, Zlotkin S, Briend A, Dewey KG. Randomized comparison of 3 types of micronutrient supplements for home fortification of complementary foods in Ghana: effects on growth and motor development. Am J Clin Nutr. 2007;86(2):412-20.
35. Christofides A, Asante KP, Schauer C, Sharieff W, Owusu-Agyei S, Zlotkin S. Multi-micronutrient Sprinkles including a low dose of iron provided as microencapsulated ferrous fumarate improves haematologic indices in anaemic children: a randomized clinical trial. Matern Child Nutr. 2006;2(3):169-80.
36. Lundeen E, Schueth T, Toktobaev N, Zlotkin S, Hyder SM, Houser R. Daily use of Sprinkles micronutrient powder for 2 months reduces anemia among children 6 to 36 months of age in the Kyrgyz Republic: a cluster-randomized trial. Food Nutr Bull. 2010;31(3):446-60.
37. Suchdev PS, De-Regil LM, Walleser S, Vist GE, Pena-Rosas JP. Multiple micronutrient powders for home (point of use) fortification of foods in pregnant women: a systematic review. Geneva: World Health Organization, 2011.
38. Guidelines on co-trimoxazole prophylaxis for hiv-related infections among children, adolescents and adults. Geneva: World Health Organization, 2006.
39. Maitland K, Molyneux S, Boga M, Kiguli S, Lang T. Use of deferred consent for severely ill children in a multi-centre phase III trial. Trials. 2011;12:90.
40. Molyneux S, Njue M, Boga M, Akello L, Olupot-Olupot P, Engoru C, et al. 'The words will pass with the blowing wind': staff and parent views of the deferred consent process, with prior assent, used in an emergency fluids trial in two African hospitals. PLoS One. 2013;8(2):e54894.
41. Olupot-Olupot P, Engoru C, Thompson J, Nteziyaremye J, Chebet M, Ssenyondo T, et al. Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia. BMC Med. 2014;12(1):67.
42. WHO. Global database on blood safety: report 2004-2005. Geneva: 2008
43. Tapko JB, Sam O, Diarra-Nama AJ. Status of blood safety in the WHO African Region: report of the 2004 survey. Brazzaville: WHO Regional Office for Africa; 2007.
44. Ala F, Allain JP, Bates I, Boukef K, Boulton F, Brandful J, et al. External financial aid to blood transfusion services in sub-Saharan Africa: a need for reflection. PLoS Med. 2012;9(9):e1001309.