Abstract
Objectives
The main secondary objective of OptiMA-DRC trial was to compare the OptiMA strategy, ie.supplementing with one product, ready-to-use therapeutic food at a gradually reduced doses, with the current national nutritionnal standard protocol in children with uncomplicated severe acute malnutrition (SAM) at inclusion (MUAC < 115 mm or WHZ< −3 or oedema) in both arms.
Methods
This non-inferiority, individually randomised controlled clinical trial was conducted in Kasai province, Democratic Republic of Congo (DRC) between July 2019 and July 2020. Children 6–59 months with MUAC < 115 mm or weight-for-height Zscore (WHZ)< −3 or oedema and without medical complication were randomized to either the OptiMA or standard arm and followed for 6 months.. Recovery was defined as MUAC > 125 mm for OptiMA and MUAC > 125 mm or WHZ >−1.5 for the standard arm, and absence of oedema, for two consecutive weeks in treatment with a 4-week minimum stay, and at any time during 6-months post-inclusion. Non-inferiority was shown if the upper-bound of the 95%CI of the difference of proportion of recovery between the two strategies was less than 10% in both intention-to-treat (ITT) and per-protocol (PP) analyses. Superiority (upper-bound of the 95%CI of this difference lower than 0%) was considered if non-inferiority was shown.
Results
Overall, 482 children with uncomplicated SAM were included in ITT analysis (242 OptiMA, 240 standard). At 6 months, 231 (95·5%) children recovered under OptiMA versus 234 (97·5%) under standard protocol (difference −2·0%, 95%CI: −1·96% to 6·4%). PP analysis was similar. There was no difference in hospitalization (11% OptiMA, 12% standard, P = 0·887) or mortality rates (0·2% both arms). Under OptiMA, weight and MUAC gains in recovered children (N = 465) were greater (median weight gain, 1400g versus 1200g, P< 0·001; median MUAC gain, 14 mm versus 11 mm, P < 0·001) and RUTF consumption (sachets) was lower (median 74 versus 112, P < 0·001).
Conclusions
Children with uncomplicated SAM recovered as well under OptiMA as under the DRC standard protocol. Gradual RUTF reduction may allow for increased nutrition program coverage by better allocating available resources.
Funding Sources
Innocent Foundation (London) European Civil Protection and Humanitarian Aid Operations (Brussels).
Severe acute malnutrition in children admitted in an Intensive Therapeutic and Feeding Centre of South Kivu, Eastern Democratic Republic of Congo: Why do our patients die?
