A simplified, combined protocol versus standard treatment for acute malnutrition in children 6–59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan

Authors: BAILEY, JEANETTE - International Rescue Committee; OPONDO, CHARLES - London School Of Hygiene & Tropical Medicine; LELIJVELD, NATASHA - No Wasted Lives; MARRON, BETHANY - International Rescue Committee; ONYO, PAMELA - Action Against Hunger; MUSYOKI, EUNICE - International Rescue Committee; ADONGO, SUSAN - International Rescue Committee; MANARY, MARK - Children'S Nutrition Research Center (CNRC); BRIEND, ANDRÉ - University Of Tampere; KERAC, MARKO - London School Of Hygiene & Tropical Medicine

Submitted to: PLoS Medicine
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 6/9/2020
Publication Date: 7/9/2020
Citation: Bailey, J., Opondo, C., Lelijveld, N., Marron, B., Onyo, P., Musyoki, E.N., Adongo, S.W., Manary, M., Briend, A., Kerac, M. 2020. A simplified, combined protocol versus standard treatment for acute malnutrition in children 6–59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan. PLoS Medicine. https://doi.org/10.1371/journal.pmed.1003192.
DOI: https://doi.org/10.1371/journal.pmed.1003192

Interpretive Summary: Children with severe acute malnutrition (SAM) and moderate acute malnutrition (MAM) have been treated separately, using different feeding products, protocols, and programs with low coverage limiting the global impact of the recovery programs. This trial compared a combined treatment for SAM and MAM against the standard care in Kenya and South Sudan. The combined protocol was as effective and cost less, which will help resource-constrained health systems enabling more children to recover from malnutrition.

Technical Abstract: Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6–59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally. A cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) < 11.5 cm and/or edema, and 1 sachet of RUTF per day for those with MUAC 11.5 to <12.5 cm. Standard care clinics treated SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF). The primary outcome was nutritional recovery. Secondary outcomes included cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains. Main analyses were per-protocol, with intention-to-treat analyses also conducted. The non-inferiority margin was 10%. From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male). In total, 1,286 (62.1%) and 1,202 (59.0%), respectively, completed treatment; 981 (76.3%) on the combined protocol and 884 (73.5%) on the standard protocol recovered, yielding a risk difference of 0.03 (95% CI -0.05 to 0.10, p = 0.52; per-protocol analysis, adjusted for country, age, and sex). The amount of ready-to-use food (RUTF or RUSF) required for a child with SAM to reach full recovery was less in the combined protocol (122 versus 193 sachets), and the combined protocol cost US$123 less per child recovered (US$918 versus US$1,041). There were 23 (1.8%) deaths in the combined protocol arm and 21 (1.8%) deaths in the standard protocol arm (adjusted risk difference 95% CI -0.01 to 0.01, p = 0.87). There was no evidence of a difference between the protocols for any of the other secondary outcomes. Study limitations included contextual factors leading to defaulting, a combined multi-country power estimate, and operational constraints. Combined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings).