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Co-trimoxazole or multivitamin multimineral supplement for post-discharge outcomes after severe anaemia in African children: a randomised controlled trial

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Maitland, Kathryn, Olupot-Olupot, Peter, Kiguli, Sarah, Chagaluka, George, Alaroker, Florence, Opoka, Robert O, Mpoya, Ayub, Walsh, Kevin, Engoru, Charles, Nteziyaremye, Julius, Mallewa, Machpherson, Kennedy, Neil, Nakuya, Margaret, Namayanja, Cate, Kayaga, Julianne, Nabawanuka, Eva, Sennyondo, Tonny, Aromut, Denis, Kumwenda, Felistas, Musika, Cynthia Williams, Thomason, Margaret J, Bates, Imelda ORCID: https://orcid.org/0000-0002-0862-8199, von Hensbroek, Michael Boele, Evans, Jennifer A, Uyoga, Sophie, Williams, Thomas N, Frost, Gary, George, Elizabeth C, Gibb, Diana M and Walker, A Sarah (2019) 'Co-trimoxazole or multivitamin multimineral supplement for post-discharge outcomes after severe anaemia in African children: a randomised controlled trial'. Lancet Global Health, Vol 7, Issue 10, e1435-e1447.

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Abstract

Background Severe anaemia is a leading cause of paediatric admission to hospital in Africa; post-discharge outcomes
remain poor, with high 6-month mortality (8%) and re-admission (17%). We aimed to investigate post-discharge
interventions that might improve outcomes.
Methods Within the two-stratum, open-label, multicentre, factorial randomised TRACT trial, children aged 2 months
to 12 years with severe anaemia, defined as haemoglobin of less than 6 g/dL, at admission to hospital (three in
Uganda, one in Malawi) were randomly assigned, using sequentially numbered envelopes linked to a second nonsequentially
numbered set of allocations stratified by centre and severity, to enhanced nutritional supplementation
with iron and folate-containing multivitamin multimineral supplements versus iron and folate alone at treatment
doses (usual care), and to co-trimoxazole versus no co-trimoxazole. All interventions were administered orally and
were given for 3 months after discharge from hospital. Separately reported randomisations investigated transfusion
management. The primary outcome was 180-day mortality. All analyses were done in the intention-to-treat population;
follow-up was 180 days. This trial is registered with the International Standard Randomised Controlled Trial registry,
ISRCTN84086586, and follow-up is complete.
Findings From Sept 17, 2014, to May 15, 2017, 3983 eligible children were randomly assigned to treatment, and followed
up for 180 days. 164 (4%) were lost to follow-up. 1901 (95%) of 1997 assigned multivitamin multimineral supplement,
1911 (96%) of 1986 assigned iron and folate, and 1922 (96%) of 1994 assigned co-trimoxazole started treatment. By day
180, 166 (8%) children in the multivitamin multimineral supplement group versus 169 (9%) children in the iron and
folate group had died (hazard ratio [HR] 0·97, 95% CI 0·79–1·21; p=0·81) and 172 (9%) who received co-trimoxazole
versus 163 (8%) who did not receive co-trimoxazole had died (HR 1·07, 95% CI 0·86–1·32; p=0·56). We found no
evidence of interactions between these randomisations or with transfusion randomisations (p>0·2). By day 180,
489 (24%) children in the multivitamin multimineral supplement group versus 509 (26%) children in the iron and folate
group (HR 0·95, 95% CI 0·84–1·07; p=0·40), and 500 (25%) children in the co-trimoxazole group versus 498 (25%) children
in the no co-trimoxazole group (1·01, 0·89–1·15; p=0·85) had had one or more serious adverse events. Most serious
adverse events were re-admissions, occurring in 692 (17%) children (175 [4%] with at least two re-admissions).
Interpretation Neither enhanced supplementation with multivitamin multimineral supplement versus iron and
folate treatment or co-trimoxazole prophylaxis improved 6-month survival. High rates of hospital re-admission
suggest that novel interventions are urgently required for severe anaemia, given the burden it places on overstretched
health services in Africa.

Item Type: Article
Subjects: QU Biochemistry > Vitamins > QU 160 Vitamins. Vitamin requirements
WA Public Health > Health Problems of Special Population Groups > WA 320 Child Welfare. Child Health Services.
WH Hemic and Lymphatic Systems > Hematologic Diseases. Immunologic Factors. Blood Banks > WH 155 Anemia
WS Pediatrics > WS 20 Research (General)
Faculty: Department: Clinical Sciences & International Health > International Public Health Department
Digital Object Identifer (DOI): https://doi.org/10.1016/S2214-109X(19)30345-6
Depositing User: Rachel Dominguez
Date Deposited: 07 Oct 2019 10:51
Last Modified: 22 Oct 2019 08:23
URI: https://archive.lstmed.ac.uk/id/eprint/12664

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