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


Autoři: Jeanette Bailey aff001;  Charles Opondo aff003;  Natasha Lelijveld aff004;  Bethany Marron aff001;  Pamela Onyo aff005;  Eunice N. Musyoki aff006;  Susan W. Adongo aff006;  Mark Manary aff007;  André Briend aff008;  Marko Kerac aff002
Působiště autorů: International Rescue Committee, New York, New York, United States of America aff001;  Department of Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom aff002;  Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom aff003;  No Wasted Lives, Action Against Hunger UK, London, United Kingdom aff004;  Action Against Hunger, Juba, South Sudan aff005;  International Rescue Committee, Nairobi, Kenya aff006;  Department of Pediatrics, Washington University School of Medicine, Saint Louis, Missouri, United States of America aff007;  Department of International Health, University of Tampere, Tampere, Finland aff008;  Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark aff009;  Centre for Maternal, Adolescent, Reproductive, & Child Health, London School of Hygiene & Tropical Medicine, London, United Kingdom aff010
Vyšlo v časopise: 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 Med 17(7): e32767. doi:10.1371/journal.pmed.1003192
Kategorie: Research Article
doi: 10.1371/journal.pmed.1003192

Souhrn

Background

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.

Methods and findings

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.

Conclusions

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). This trial is complete and registered at ISRCTN (ISRCTN30393230).

Trial registration

The trial is registered at ISRCTN, trial number ISRCTN30393230.

Klíčová slova:

Cost-effectiveness analysis – Edema – Children – Kenya – Malnutrition – Nutrition – Weight gain – South Sudan


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