scholarly journals Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a community-based individually randomised controlled trial in Kasaï, Democratic Republic of Congo

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041213
Author(s):  
Cécile Cazes ◽  
Kevin Phelan ◽  
Victoire Hubert ◽  
Rodrigue Alitanou ◽  
Harouna Boubacar ◽  
...  
Keyword(s):  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
Controlled Trial ◽  
Acute Malnutrition ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Medical Complication ◽  
Republic Of Congo ◽  
Link Type ◽  
Randomised Controlled

IntroductionAcute malnutrition (AM) is a continuum condition, arbitrarily divided into moderate and severe AM (SAM) categories, funded and managed in separate programmes under different protocols. Optimising acute MAlnutrition (OptiMA) treatment aims to simplify and optimise AM management by treating children with mid-upper arm circumference (MUAC) <125 mm or oedema with one product—ready-to-use therapeutic food—at a gradually tapered dose. Our main objective was to compare the OptiMA strategy with the standard nutritional protocol in children 6–59 months presenting with MUAC <125 mm or oedema without additional complications, as well as in children classified as uncomplicated SAM (ie, MUAC <115 mm or weight-for-height Z-score (WHZ) <−3 or with oedema).Methods and analysisThis study was a non-inferiority, individually randomised controlled clinical trial conducted at community level in the Democratic Republic of Congo. Children 6–59 months presenting with MUAC <125 mm or WHZ <−3 or with bipedal oedema and without medical complication were included after signed informed consent in outpatient health facilities. All participants were followed for 6 months. Success in both arms was defined at 6 months post inclusion as being alive, not acutely malnourished per the definition applied at inclusion and without an additional episode of AM throughout the 6-month observation period. Recovery among children with uncomplicated SAM was the main secondary outcome. For the primary objective, 890 participants were needed, and 480 children with SAM were needed for the main secondary objective. We will perform non-inferiority analyses in per-protocol and intention-to-treat basis for both outcomes.Ethics and disseminationEthics approvals were obtained from the National Health Ethics Committee of the Democratic Republic of Congo and from the Ethics Evaluation Committee of Inserm, the French National Institute for Health and Medical Research (Paris, France). We will submit results for publication to a peer-reviewed journal and disseminate findings in international and national conferences and meetings.Trial registration numberNCT03751475. Registered 19 September 2018, https://clinicaltrials.gov/ct2/show/NCT03751475.

scholarly journals Optimising Malnutrition Treatment – OptiMA-DRC: Recovery of Severely Wasted Children 6–59 Months in a Randomised Control Trial in Democratic Republic of Congo

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 110-110
Author(s):  
Cécile Cazes ◽  
Kevin Phelan ◽  
Victoire Hubert ◽  
Harouna Boubacar ◽  
Gilbert Tshibangu Sakubu ◽  
...  
Keyword(s):  
Upper Bound ◽  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
Severe Acute Malnutrition ◽  
Acute Malnutrition ◽  
Randomised Control Trial ◽  
Controlled Clinical Trial ◽  
Medical Complication ◽  
Standard Protocol ◽  
Republic Of Congo

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 &lt; 115 mm or WHZ&lt; −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 &lt; 115 mm or weight-for-height Zscore (WHZ)&lt; −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 &gt; 125 mm for OptiMA and MUAC &gt; 125 mm or WHZ &gt;−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&lt; 0·001; median MUAC gain, 14 mm versus 11 mm, P &lt; 0·001) and RUTF consumption (sachets) was lower (median 74 versus 112, P &lt; 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).

scholarly journals Optimising Malnutrition Treatment in Children 6–59 Months-OptiMA-DRC: Primary Outcome of a Randomised Control Trial in Democratic Republic of Congo

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 111-111
Author(s):  
Cécile Cazes ◽  
Kevin Phelan ◽  
Victoire Hubert ◽  
Harouna Boubacar ◽  
Liévin Izie Bozama ◽  
...  
Keyword(s):  
Upper Bound ◽  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
Favourable Outcome ◽  
Acute Malnutrition ◽  
National Standard ◽  
Randomised Control Trial ◽  
Controlled Clinical Trial ◽  
Standard Protocol ◽  
Republic Of Congo

Abstract 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 &lt; 125 mm or weight-for-height Zscore&lt; −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 consumption during treatment, and led to better outcomes at 6-months post inclusion. These results suggest benefits in giving smaller rations of RUTF at an earlier stage of malnutrition rather than larger rations only when children become severely malnourished. Funding Sources Innocent Foundation (London) European Civil Protection and Humanitarian Aid Operations (Brussels).

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

scholarly journals 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?

PLoS ONE ◽  
2020 ◽  
Vol 15 (7) ◽  
pp. e0236022 ◽  
Author(s):  
Richard Mbusa Kambale ◽  
Gaylord Amani Ngaboyeka ◽  
Joseph Ntagerwa Ntagazibwa ◽  
Marie-Hélène Igega Bisimwa ◽  
Lisa Yvette Kasole ◽  
...  
Keyword(s):  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
Severe Acute Malnutrition ◽  
Acute Malnutrition ◽  
Republic Of Congo ◽  
South Kivu

scholarly journals Effect of ‘hand and foot acupuncture with twelve needles’ on hemiplegia patients with ‘qi deficiency and blood stasis’ syndrome in the convalescent stage of Ischaemic stroke: study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Wei-Hao Fang ◽  
Gui-Ling Wang ◽  
Qiang Liu ◽  
Xiao Ding ◽  
Zhen-Yao Wang ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Controlled Trial ◽  
Blood Stasis ◽  
Blood Stasis Syndrome ◽  
Controlled Clinical Trial ◽  
Link Type ◽  
Stroke Study ◽  
Group A ◽  
Randomised Controlled ◽  
Convalescent Stage

Abstract Background Hemiplegia is a common sequela after stroke, and acupuncture is one of the most common physical therapies used to treat hemiplegia during the recovery stage after ischaemic stroke. ‘Hand and foot acupuncture with twelve needles’ is an acupuncture treatment performed after stroke. The principal objective of this study is to assess the efficacy and safety of ‘hand and foot acupuncture with twelve needles’ for hemiplegia in the convalescent stage of ischaemic stroke. Methods This is the protocol for a randomised, controlled clinical trial with two groups: a ‘hand and foot acupuncture with twelve needles’ group and a routine acupuncture group. A total of 208 participants will be randomly assigned to two different groups in a 1:1 ratio and will undergo conventional rehabilitation. Limb function will be evaluated by the simplified Fugl-Meyer assessment scale, Barthel Index, modified Ashworth scale and National Institute of Health stroke scale. The participants will be evaluated at baseline (on the day of enrolment) and followed up at 2 weeks, 1 month, 2 months and 3 months after enrolment. Discussion The results of this study will provide evidence on the effectiveness of ‘hand and foot acupuncture with twelve needles’ in the treatment of limb dysfunction that can be used for future evaluations. Trial registration Chictr.org.cnChiCTR1900021774. Registered on 8 March 2019

scholarly journals Follow-up of a historic cohort of children treated for severe acute malnutrition between 1988 and 2007 in Eastern Democratic Republic of Congo

PLoS ONE ◽  
2020 ◽  
Vol 15 (3) ◽  
pp. e0229675 ◽  
Author(s):  
Pacifique Mwene-Batu ◽  
Ghislain Bisimwa ◽  
Gaylord Ngaboyeka ◽  
Michelle Dramaix ◽  
Jean Macq ◽  
...  
Keyword(s):  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
Severe Acute Malnutrition ◽  
Acute Malnutrition ◽  
Republic Of Congo ◽  
Historic Cohort

scholarly journals Field Assessment of a Novel Household-Based Water Filtration Device: A Randomised, Placebo-Controlled Trial in the Democratic Republic of Congo

PLoS ONE ◽  
2010 ◽  
Vol 5 (9) ◽  
pp. e12613 ◽  
Author(s):  
Sophie Boisson ◽  
Mbela Kiyombo ◽  
Larry Sthreshley ◽  
Saturnin Tumba ◽  
Jacques Makambo ◽  
...  
Keyword(s):  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
Controlled Trial ◽  
Water Filtration ◽  
Republic Of Congo ◽  
Field Assessment ◽  
Filtration Device
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