About: 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

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About: 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 Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	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
Creator	Manary, Mark Adongo, Susan Briend Id, André Id, Jeanette Id, Natasha Kerac Id, Marko Marron, Bethany Musyoki, Eunice Onyo, Pamela Opondo Id, Charles
Source	Medline; PMC
abstract	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.
has issue date	2020-07-09(xsd:dateTime)
bibo:doi	10.1371/journal.pmed.1003192
bibo:pmid	32645109
has license	cc-by
sha1sum (hex)	c1240e06763e20724825433ef0d116b4ab23c958
schema:url	https://doi.org/10.1371/journal.pmed.1003192
resource representing a document's title	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
has PubMed Central identifier	PMC7347103
has PubMed identifier	32645109
schema:publication	PLoS Med
resource representing a document's body	covid:c1240e06763e20724825433ef0d116b4ab23c958#body_text
is schema:about of	named entity 'PROGRAMS' named entity 'ACUTE' named entity 'REACHING' named entity 'SAM' named entity 'COST' named entity 'STUDY' named entity 'NEED FOR' named entity 'TREATING' covid:arg/c1240e06763e20724825433ef0d116b4ab23c958 named entity 'Current treatments' named entity 'South Sudan' named entity 'Kenya' named entity 'per-protocol analysis' named entity 'follow-up' named entity '95% CI' named entity 'SAM' named entity 'SAM' named entity 'case fatality rate' named entity 'gold standard' named entity 'Aweil East' named entity 'OTPs' named entity 'Stata' named entity 'SAM' named entity 'therapeutic foods' named entity 'standard deviations' named entity 'acute malnutrition' named entity 'OTPs' named entity 'SAM' named entity 'acute malnutrition' named entity 'edema' named entity 'public health' named entity 'acute malnutrition' named entity 'intention-to-treat analysis' named entity 'lost to follow-up' named entity 'per-protocol analysis' named entity 'Nairobi' named entity 'adverse events' named entity 'z-score' named entity 'Aweil East' named entity 'SAM' named entity 'risk difference' named entity 'edema' named entity 'ComPAS' named entity 'SAM' named entity 'malnourished' named entity '50 million' named entity 'SAM' named entity '0.01' named entity 'cost-effective' named entity 'Kaplan-Meier' named entity 'supply chain' named entity 'malnourished children' named entity 'inpatient care' named entity 'RUTF' named entity 'UNICEF' named entity 'edema' named entity 'per-protocol analysis' named entity 'Kiswahili' named entity '11.5' named entity 'upper bound' named entity 'sachet' named entity 'RUTF' named entity '11.5' named entity 'follow-up' named entity 'global public health' named entity 'Embakasi North' named entity 'linear regression models' named entity 'cost-effectiveness' named entity 'Kenya' named entity 'South Sudan' named entity 'SAM' named entity 'SAM'

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