Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition

Official title

Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition in Children Aged 6-59 Months in Burkina Faso: Reduced Dose of RUTF for SAM Children and RUTF Instead of RUSF for MAM Children

Overview

This experimental study aims to test an alternative protocol for managing acute malnutrition in children aged 6-59 months in Burkina Faso. This alternative protocol consists of using RUTF instead of RUSF for the management of moderate acute malnutrition and reduced-dose RUTF instead of standard-dose RUTF for the treatment of severe acute malnutrition. The main questions are: 1. Does treating children with moderate acute malnutrition using RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with RUSF? 2. Does treating children with uncomplicated severe acute malnutrition using a reduced dose of RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with a standard dose of RUFT? Secondly, the study will investigate the effect of this alternative protocol compared to the standard protocol on cost-effectiveness, psychomotor development, weight and linear growth and incidence of relapses.

Detailed description

In this trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for severe acute malnutrition (SAM) without complication and 1:1 for moderate acute malnutrition (MAM).

Supplementation will be daily according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment will be done. Those who recovered before or at this point will be subsequently followed up monthly for up to 3 months for sustained recovery assessment.

Follow-up visits will be done at the health center every week for children with SAM and every two weeks for children with MAM.

At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements.

The evaluation of the psychomotor development will be performed in a subsample.

Interventions

• Dietary supplement ready-to-use therapeutic food (for children with MAM)
  Each child with MAM will be supplemented with RUTF for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks.
• Dietary supplement Ready-to-use supplementary food
  Each child with MAM will be supplemented with RUSF for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks post recovery
• Dietary supplement Ready to Use Therapeutic Food - Reduced dose 1
  Each child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal/kg/day of RUTF until programmatic recovery. He/she will be followed subsequently up to 24 weeks post recovery.
• Dietary supplement Ready to Use Therapeutic Food - Standard dose
  Each child with SAM will be treated with a standard dose (according to the national protocol for the integrated management of acute malnutrition in Burkina Faso) for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks post recovery.
• Dietary supplement Ready to Use Therapeutic Food - Reduced dose 2
  Each child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal/kg/day of RUTF until the child is no longer severely malnourished and does not have nutritional oedema then 100-130 kcal/kg/day of RUTF until programmatic recovery. He/she will be followed subsequently up to 24 weeks post recovery.

Primary outcome measures

• Rate of programmatic recovery [Time frame: From enrollment to the end of treatment (maximum 12 weeks)]
• Rate of sustained recovery [Time frame: from programmatic recovery to 3 months after]

Secondary outcome measures (11)

• Cost per child treated [Time frame: From enrollment to the end of treatment (maximum 12 weeks)]
• Cost per child recovered [Time frame: From enrollment to the end of treatment (maximum 12 weeks)]
• Score of the extended version of Developmental Milestones Checklist (DMC-II) [Time frame: Three points : enrollment , exit of the supplementation program (up to 12 weeks) and exit of the study (3 months after recovery)]
• Daily weight gain [Time frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)]]
• Daily length gain [Time frame: [Time Frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)]
• Energy intake [Time frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)]
• Rate of relapses [Time frame: from programmatic recovery to 3 months after]
• Length of stay [Time frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)]
• Rate of defaulted [Time frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)]
• Rate of treatment failure [Time frame: From enrollment to the end of treatment (maximum 12 weeks)]
• Number of adverse events [Time frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)]

Eligibility criteria

• MAM

Inclusion criteria

• Anthropometric measures:

• (115 mm ≤ MUAC< 125 mm and -3 SDs ≤ WLZ < -2 SDs) OR
• (115 mm ≤ MUAC< 125 mm and WLZ ≥ -2 SDs) OR
• (MUAC ≥ 125 mm and -3 SDs ≤ WLZ < -2 SDs).
• Age: 6 to 59 months
• Parents' acceptance of biweekly visits until programme discharge and monthly visits for the post-programme follow up

Exclusion criteria

• Failure of appetite test
• Medical complications requiring hospital treatment
• Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection
• Presence of bilateral oedema
• History of allergies to peanuts, milk, or soya
• Relapse from MAM treatment or transfer from SAM treatment
• Children who have recently (<2 months) taken part in a nutrition programme;
• Residence outside the study area
• Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)
• SAM

Inclusion criteria

• Anthropometric measures MUAC< 115 mm or WLZ< - 3 SDs;
• Age: 6-59 months;
• Parents' acceptance of weekly visits until programme discharge and monthly visits for the post-programme follow up.

Exclusion criteria

• Failure of appetite test
• Medical complications requiring hospital treatment
• Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection
• Presence of bilateral oedema
• History of allergies to peanuts, milk or soya
• Relapse from MAM treatment or transfer from SAM treatment
• Children who have recently (<2 months) taken part in a nutrition programme;
• Residence outside the study area;
• Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Burkina Faso · 1 center

• Institut de Recherche en Sciences de la Santé — Ouagadougou

Publications

• Chang CY, Trehan I, Wang RJ, Thakwalakwa C, Maleta K, Deitchler M, Manary MJ. Children successfully treated for moderate acute malnutrition remain at risk for malnutrition and death in the subsequent year after recovery. J Nutr. 2013 Feb;143(2):215-20. doi: 10.3945/jn.112.168047. Epub 2012 Dec 19. PMID 23256140
• Bailey J, Lelijveld N, Khara T, Dolan C, Stobaugh H, Sadler K, Lino Lako R, Briend A, Opondo C, Kerac M, Myatt M. Response to Malnutrition Treatment in Low Weight-for-Age Children: Secondary Analyses of Children 6-59 Months in the ComPAS Cluster Randomized Controlled Trial. Nutrients. 2021 Mar 24;13(4):1054. doi: 10.3390/nu13041054. PMID 33805040
• Maru Y, Tamiru D, Baye K, Chitekwe S, Laillou A, Darsene H, Abdulai R, Worku M, Belachew T. Effect of a simplified approach on recovery of children 6-59 months with wasting in Ethiopia: A noninferiority, cluster randomized controlled trial. Matern Child Nutr. 2024 Oct;20(4):e13670. doi: 10.1111/mcn.13670. Epub 2024 May 27. PMID 38800892
• Singh AS, Kang G, Ramachandran A, Sarkar R, Peter P, Bose A. Locally made ready to use therapeutic food for treatment of malnutrition a randomized controlled trial. Indian Pediatr. 2010 Aug;47(8):679-86. doi: 10.1007/s13312-010-0100-8. PMID 20972285
• Nackers F, Broillet F, Oumarou D, Djibo A, Gaboulaud V, Guerin PJ, Rusch B, Grais RF, Captier V. Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blend-based pre-mix for the treatment of childhood moderate acute malnutrition in Niger. J Trop Pediatr. 2010 Dec;56(6):407-13. doi: 10.1093/tropej/fmq019. Epub 2010 Mar 23. PMID 20332221
• Medoua GN, Ntsama PM, Ndzana AC, Essa'a VJ, Tsafack JJ, Dimodi HT. Recovery rate of children with moderate acute malnutrition treated with ready-to-use supplementary food (RUSF) or improved corn-soya blend (CSB+): a randomized controlled trial. Public Health Nutr. 2016 Feb;19(2):363-70. doi: 10.1017/S1368980015001238. Epub 2015 May 5. PMID 25939394
• LaGrone LN, Trehan I, Meuli GJ, Wang RJ, Thakwalakwa C, Maleta K, Manary MJ. A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children. Am J Clin Nutr. 2012 Jan;95(1):212-9. doi: 10.3945/ajcn.111.022525. Epub 2011 Dec 14. PMID 22170366
• Griswold SP, Langlois BK, Shen Y, Cliffer IR, Suri DJ, Walton S, Chui K, Rosenberg IH, Koroma AS, Wegner D, Hassan A, Manary MJ, Vosti SA, Webb P, Rogers BL. Effectiveness and cost-effectiveness of 4 supplementary foods for treating moderate acute malnutrition: results from a cluster-randomized intervention trial in Sierra Leone. Am J Clin Nutr. 2021 Sep 1;114(3):973-985. doi: 10.1093/ajcn/nqab140 PMID 34020452

Identifiers

NCT: NCT06792370 · INV-016380-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗