Suchergebnisse

OBJECTIVES: The main objective was to compare the OptiMA strategy- ie.supplementing with ready-to-use therapeutic food at a gradually reduced doses- with the current national standard protocol. METHODS: This non-inferiority, individually randomised controlled clinical trial was conducted in the Democratic Republic of Congo. Children 6–59 months with MUAC < 125 mm or weight-for-height Zscore< −3 or oedema and without medical complication were randomized to either OptiMA or standard arm and followed for 6 months. The main outcome was a binary composite indicator at 6-months post inclusion: child alive, not acutely malnourished per the study definition, and without an additional episode of acute malnutrition throughout the observation period. Non-inferiority was shown if the upper-bound of the 95% CI of the difference of proportion of favourable outcome 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: Between July 2019 and July 2020, 981 children were enrolled. 896 children were included in the ITT analysis (450 OptiMA and 446 standard), 792 in the PP analysis. All children under OptiMA and 200 children in the standard arm were eligible for RUTF. ITT analysis showed 325 (72·2%) children had a favourable outcome under OptiMA versus 282 (63·2%) in the standard arm (difference: −9·2%, 95% CI: −15·9% to −2·0%). PP analysis was similar. Under OptiMA, weight and MUAC gain were greater (median weight gain, 1700 g versus 1600 g, P = 0·003 and median MUAC gain, 13 mm versus 12 mm, P = 0·012), and RUTF consumption was lower (median of 64 sachets versus 102 sachets, P = 0·018). There was no difference in hospitalization (10% OptiMA, 7% standard, P = 0·228) or mortality rates (0·2% in both arms). CONCLUSIONS: OptiMA was superior to the DRC standard protocol. It expanded access to RUTF, promoted improved anthropometry with lower RUTF ...

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 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 ...

International audience ; BACKGROUND: Global access to acute malnutrition treatment is low. Different programmes using different nutritional products manage cases of severe acute malnutrition and moderate acute malnutrition separately. We aimed to assess whether integrating severe acute malnutrition and moderate acute malnutrition treatment into one programme, using a single nutritional product and reducing the dose as the child improves, could achieve similar or higher individual efficacy, increase coverage, and minimise costs compared with the current programmes.METHODS: We conducted an open-label, non-inferiority, randomised controlled trial in the Democratic Republic of the Congo. Acutely malnourished children aged 6-59 months with a mid-upper-arm circumference (MUAC) of less than 125 mm or oedema were randomly assigned (1:1), using specially developed software and random blocks (size was kept confidential), to either the current standard strategy (one programme for severe acute malnutrition using ready-to-use therapeutic food [RUTF] at an increasing dose as weight increased, another for moderate acute malnutrition using a fixed dose of ready-to-use supplementary food [RUSF]) or the OptiMA strategy (a single programme for both severe acute malnutrition and moderate acute malnutrition using RUTF at a decreasing dose as MUAC and weight increased). The primary endpoint was a favourable outcome at 6 months, defined as being alive, not acutely malnourished as per the definition applied at inclusion, and with no further episodes of acute malnutrition throughout the 6-month observation period; the endpoint was analysed in the intention-to-treat (all children) and per-protocol populations (participants who had a minimum prescription of 4 weeks' RUTF, received at least 90% of the total amount of RUTF they were supposed to receive as per the protocol, or were prescribed RUSF rations for a minimum of 4 weeks [ie, minimum of 28 RUSF sachets], and had a maximum interval of 6 weeks between any two visits in the 6-month ...

International audience ; BACKGROUND: Global access to acute malnutrition treatment is low. Different programmes using different nutritional products manage cases of severe acute malnutrition and moderate acute malnutrition separately. We aimed to assess whether integrating severe acute malnutrition and moderate acute malnutrition treatment into one programme, using a single nutritional product and reducing the dose as the child improves, could achieve similar or higher individual efficacy, increase coverage, and minimise costs compared with the current programmes.METHODS: We conducted an open-label, non-inferiority, randomised controlled trial in the Democratic Republic of the Congo. Acutely malnourished children aged 6-59 months with a mid-upper-arm circumference (MUAC) of less than 125 mm or oedema were randomly assigned (1:1), using specially developed software and random blocks (size was kept confidential), to either the current standard strategy (one programme for severe acute malnutrition using ready-to-use therapeutic food [RUTF] at an increasing dose as weight increased, another for moderate acute malnutrition using a fixed dose of ready-to-use supplementary food [RUSF]) or the OptiMA strategy (a single programme for both severe acute malnutrition and moderate acute malnutrition using RUTF at a decreasing dose as MUAC and weight increased). The primary endpoint was a favourable outcome at 6 months, defined as being alive, not acutely malnourished as per the definition applied at inclusion, and with no further episodes of acute malnutrition throughout the 6-month observation period; the endpoint was analysed in the intention-to-treat (all children) and per-protocol populations (participants who had a minimum prescription of 4 weeks' RUTF, received at least 90% of the total amount of RUTF they were supposed to receive as per the protocol, or were prescribed RUSF rations for a minimum of 4 weeks [ie, minimum of 28 RUSF sachets], and had a maximum interval of 6 weeks between any two visits in the 6-month ...