Conference Material > Abstract
Mahajan R, Edwards T, Shandilya C, Kashyap V, Marino E, et al.
MSF Scientific Days International 2021: Research. 2021 May 19
INTRODUCTION
Limited data exist to inform community management of children with moderate acute malnutrition (MAM), who are normally excluded from severe acute malnutrition (SAM) treatment programmes. This study was conducted to generate evidence of longitudinal outcomes in children aged 6-59 months with MAM (defined as mid-upper arm circumference, MUAC, 115-124mm), without interventional supplementary feeding. In this study, children in India with MAM were followed up for six months to better understand their long-term nutritional outcomes.
METHODS
We carried out a multicentre prospective longitudinal observational study, nested within a randomized trial, in Jharkhand, India. Children with MAM were enrolled over a 12-month period in 46 centres in Jharkhand state, and followed up for six months while attending government integrated child development services. Anthropometric, clinical and sociodemographic characteristics were recorded at enrolment. The primary outcome was deterioration to SAM (MUAC <115 or bilateral pitting oedema) or death within six months. Risk factors for this outcome were investigated.
ETHICS
This study was approved by the MSF Ethical Review Board and by the ethics review boards of the Rajendra Institute of Medical Sciences, Ranchi and Jawaharlal Nehru University, New Delhi, India, and London School of Hygiene & Tropical Medicine, UK. Clinical Trial Registry-India number, CTRI/2017/12/010743.
RESULTS
Of 971 children enrolled, 98 (10.0%) were lost to follow-up, mainly linked with seasonal migration; 12 were seen outside of the six-month window (three before day 168 and nine after day 210). Of 861 children included in the analysis, 595 (61.3%) were female, with a mean age of 16.0 months (standard deviation 9.7). At enrolment 333 (34.3%) had MUAC 115-119mm, 430 (44.3%) had weight-for-height z-score (WHZ) <-3 and 431 (44%) had a WHZ of -2 to-3. Within six months, 133 (15.5%) deteriorated to SAM or died (95% confidence interval, CI: 13.1-18.0%; five deaths), of whom 97 children deteriorated to poor outcome (SAM or death) by three months (11.3%, with one death; representing over two thirds of those deteriorating to poor outcome by six months). In an adjusted logistic regression model, with an interaction between MUAC at enrolment (115-119, 120-124mm) and age (6-11, 12-23, ≥24 months), significantly increased odds of deterioration to SAM or death were seen amongst those with MUAC 115-119mm in all age groups (p≤0.02) and in those under one year with MUAC<125mm. After adjustment, there was no evidence of associations with socio-demographic factors, breastfeeding or WHZ<-3.
CONCLUSION
Children aged under 1 year and children with MUAC 115-119mm should be closely monitored, considering high MAM burdens in India. Increasing the MUAC admission criterion and/or targeted interventions for MAM children at higher risk could be considered. WHZ<-3 not already MUAC<115mm does not appear to be a risk factor for deterioration.
Limited data exist to inform community management of children with moderate acute malnutrition (MAM), who are normally excluded from severe acute malnutrition (SAM) treatment programmes. This study was conducted to generate evidence of longitudinal outcomes in children aged 6-59 months with MAM (defined as mid-upper arm circumference, MUAC, 115-124mm), without interventional supplementary feeding. In this study, children in India with MAM were followed up for six months to better understand their long-term nutritional outcomes.
METHODS
We carried out a multicentre prospective longitudinal observational study, nested within a randomized trial, in Jharkhand, India. Children with MAM were enrolled over a 12-month period in 46 centres in Jharkhand state, and followed up for six months while attending government integrated child development services. Anthropometric, clinical and sociodemographic characteristics were recorded at enrolment. The primary outcome was deterioration to SAM (MUAC <115 or bilateral pitting oedema) or death within six months. Risk factors for this outcome were investigated.
ETHICS
This study was approved by the MSF Ethical Review Board and by the ethics review boards of the Rajendra Institute of Medical Sciences, Ranchi and Jawaharlal Nehru University, New Delhi, India, and London School of Hygiene & Tropical Medicine, UK. Clinical Trial Registry-India number, CTRI/2017/12/010743.
RESULTS
Of 971 children enrolled, 98 (10.0%) were lost to follow-up, mainly linked with seasonal migration; 12 were seen outside of the six-month window (three before day 168 and nine after day 210). Of 861 children included in the analysis, 595 (61.3%) were female, with a mean age of 16.0 months (standard deviation 9.7). At enrolment 333 (34.3%) had MUAC 115-119mm, 430 (44.3%) had weight-for-height z-score (WHZ) <-3 and 431 (44%) had a WHZ of -2 to-3. Within six months, 133 (15.5%) deteriorated to SAM or died (95% confidence interval, CI: 13.1-18.0%; five deaths), of whom 97 children deteriorated to poor outcome (SAM or death) by three months (11.3%, with one death; representing over two thirds of those deteriorating to poor outcome by six months). In an adjusted logistic regression model, with an interaction between MUAC at enrolment (115-119, 120-124mm) and age (6-11, 12-23, ≥24 months), significantly increased odds of deterioration to SAM or death were seen amongst those with MUAC 115-119mm in all age groups (p≤0.02) and in those under one year with MUAC<125mm. After adjustment, there was no evidence of associations with socio-demographic factors, breastfeeding or WHZ<-3.
CONCLUSION
Children aged under 1 year and children with MUAC 115-119mm should be closely monitored, considering high MAM burdens in India. Increasing the MUAC admission criterion and/or targeted interventions for MAM children at higher risk could be considered. WHZ<-3 not already MUAC<115mm does not appear to be a risk factor for deterioration.
Journal Article > ResearchFull Text
Eur J Clin Nutr. 2015 September 2; Volume 70 (Issue 4); 437-444.; DOI:10.1038/ejcn.2015.140
Burza S, Mahajan R, Marino E, Sunyoto T, Shandilya C, et al.
Eur J Clin Nutr. 2015 September 2; Volume 70 (Issue 4); 437-444.; DOI:10.1038/ejcn.2015.140
BACKGROUND/OBJECTIVES
Children aged 6 months to 5 years completing treatment for severe acute malnutrition (SAM) in a Médecins Sans Frontières Community Management of Acute Malnutrition (CMAM) program in Bihar, India, showed high cure rates; however, the program suffered default rates of 38%. This report describes the nutritional status of 1956 children followed up between 3 and 18 months after exiting the program.
SUBJECTS/METHODS
All children aged 6-59 months discharged as cured with mid-upper arm circumference (MUAC) ⩾120 mm or who defaulted from the program with MUAC <115 mm were traced at 3, 6, 9, 12 and 18 months (±10 days) before three exit reference dates: first at the end of the food insecure period, second after the 2-month food security and third after the 4-month food security.
RESULTS
Overall, 68.7% (n=692) of defaulters and 76.2% (n=1264) of children discharged as cured were traced. Combined rates of non-recovery in children who defaulted with MUAC <115 mm were 41%, 30.1%, 9.9%, 6.1% and 3.6% at 3, 6, 9, 12 and 18 months following exit, respectively. Combined rates of relapse among cured cases (MUAC ⩾120 mm) were 9.1%, 2.9%, 2.1%, 2.8% and 0% at 3, 6, 9, 12 and 18 months following discharge, respectively. Prevalence of undernutrition increased substantially for both groups traced during low food security periods. Odds of death were much higher for children defaulting with MUAC <110 mm when compared with children discharged as cured, who shared the same mortality risk as those defaulting with MUAC 110-<115 mm.
CONCLUSIONS
Seasonal food security predicted short-term nutritional status after exit, with relapse rates and non-recovery from SAM much higher during food insecurity. Mortality outcomes suggest that a MUAC of 110 mm may be considered an appropriate admission point for SAM treatment programs in this context.
Children aged 6 months to 5 years completing treatment for severe acute malnutrition (SAM) in a Médecins Sans Frontières Community Management of Acute Malnutrition (CMAM) program in Bihar, India, showed high cure rates; however, the program suffered default rates of 38%. This report describes the nutritional status of 1956 children followed up between 3 and 18 months after exiting the program.
SUBJECTS/METHODS
All children aged 6-59 months discharged as cured with mid-upper arm circumference (MUAC) ⩾120 mm or who defaulted from the program with MUAC <115 mm were traced at 3, 6, 9, 12 and 18 months (±10 days) before three exit reference dates: first at the end of the food insecure period, second after the 2-month food security and third after the 4-month food security.
RESULTS
Overall, 68.7% (n=692) of defaulters and 76.2% (n=1264) of children discharged as cured were traced. Combined rates of non-recovery in children who defaulted with MUAC <115 mm were 41%, 30.1%, 9.9%, 6.1% and 3.6% at 3, 6, 9, 12 and 18 months following exit, respectively. Combined rates of relapse among cured cases (MUAC ⩾120 mm) were 9.1%, 2.9%, 2.1%, 2.8% and 0% at 3, 6, 9, 12 and 18 months following discharge, respectively. Prevalence of undernutrition increased substantially for both groups traced during low food security periods. Odds of death were much higher for children defaulting with MUAC <110 mm when compared with children discharged as cured, who shared the same mortality risk as those defaulting with MUAC 110-<115 mm.
CONCLUSIONS
Seasonal food security predicted short-term nutritional status after exit, with relapse rates and non-recovery from SAM much higher during food insecurity. Mortality outcomes suggest that a MUAC of 110 mm may be considered an appropriate admission point for SAM treatment programs in this context.
Journal Article > ResearchFull Text
Am J Clin Nutr. 2015 February 25; Volume 101 (Issue 4); 847-59.; DOI:10.3945/ajcn.114.093294
Burza S, Mahajan R, Marino E, Sunyoto T, Shandilya C, et al.
Am J Clin Nutr. 2015 February 25; Volume 101 (Issue 4); 847-59.; DOI:10.3945/ajcn.114.093294
BACKGROUND
An estimated one-third of the world's children who are wasted live in India. In Bihar state, of children <5 y old, 27.1% are wasted and 8.3% have severe acute malnutrition (SAM). In 2009, Médecins Sans Frontières (MSF) initiated a community-based management of acute malnutrition (CMAM) program for children aged 6-59 mo with SAM.
OBJECTIVE
In this report, we describe the characteristics and outcomes of 8274 children treated between February 2009 and September 2011.
DESIGN
Between February 2009 and June 2010, the program admitted children with a weight-for-height z score (WHZ) <-3 SD and/or midupper arm circumference (MUAC) <110 mm and discharged those who reached a WHZ >-2 SDs and MUAC >110 mm. These variables changed in July 2010 to admission on the basis of an MUAC <115 mm and discharge at an MUAC ≥120 mm. Uncomplicated SAM cases were treated as outpatients in the community by using a WHO-standard, ready-to-use, therapeutic lipid-based paste produced in India; complicated cases were treated as inpatients by using F75/F100 WHO-standard milk until they could complete treatment in the community.
RESULTS
A total of 8274 children were admitted including 5149 girls (62.2%), 6613 children aged 6-23 mo (79.9%), and 87.3% children who belonged to Scheduled Caste, Scheduled Tribe, or Other Backward Caste families or households. Of 3873 children admitted under the old criteria, 41 children (1.1%) died, 2069 children (53.4%) were discharged as cured, and 1485 children (38.3%) defaulted. Of 4401 children admitted under the new criteria, 36 children (0.8%) died, 2526 children (57.4%) were discharged as cured, and 1591 children (36.2%) defaulted. For children discharged as cured, the mean (±SD) weight gain and length of stay were 4.7 ± 3.1 and 5.1 ± 3.7 g · kg(-1) · d(-1) and 8.7 ± 6.1 and 7.3 ± 5.6 wk under the old and new criteria, respectively (P < 0.01). After adjustment, significant risk factors for default were as follows: no community referral for admission, more severe wasting on admission, younger age, and a long commute for treatment.
CONCLUSIONS
To our knowledge, this is the first conventional CMAM program in India and has achieved low mortality and high cure rates in nondefaulting children. The new admission criteria lower the threshold for severity with the result that more children are included who are at lower risk of death and have a smaller WHZ deficit to correct than do children identified by the old criteria. This study was registered as a retrospective observational analysis of routine program data at http://www.isrctn.com as ISRCTN13980582.
An estimated one-third of the world's children who are wasted live in India. In Bihar state, of children <5 y old, 27.1% are wasted and 8.3% have severe acute malnutrition (SAM). In 2009, Médecins Sans Frontières (MSF) initiated a community-based management of acute malnutrition (CMAM) program for children aged 6-59 mo with SAM.
OBJECTIVE
In this report, we describe the characteristics and outcomes of 8274 children treated between February 2009 and September 2011.
DESIGN
Between February 2009 and June 2010, the program admitted children with a weight-for-height z score (WHZ) <-3 SD and/or midupper arm circumference (MUAC) <110 mm and discharged those who reached a WHZ >-2 SDs and MUAC >110 mm. These variables changed in July 2010 to admission on the basis of an MUAC <115 mm and discharge at an MUAC ≥120 mm. Uncomplicated SAM cases were treated as outpatients in the community by using a WHO-standard, ready-to-use, therapeutic lipid-based paste produced in India; complicated cases were treated as inpatients by using F75/F100 WHO-standard milk until they could complete treatment in the community.
RESULTS
A total of 8274 children were admitted including 5149 girls (62.2%), 6613 children aged 6-23 mo (79.9%), and 87.3% children who belonged to Scheduled Caste, Scheduled Tribe, or Other Backward Caste families or households. Of 3873 children admitted under the old criteria, 41 children (1.1%) died, 2069 children (53.4%) were discharged as cured, and 1485 children (38.3%) defaulted. Of 4401 children admitted under the new criteria, 36 children (0.8%) died, 2526 children (57.4%) were discharged as cured, and 1591 children (36.2%) defaulted. For children discharged as cured, the mean (±SD) weight gain and length of stay were 4.7 ± 3.1 and 5.1 ± 3.7 g · kg(-1) · d(-1) and 8.7 ± 6.1 and 7.3 ± 5.6 wk under the old and new criteria, respectively (P < 0.01). After adjustment, significant risk factors for default were as follows: no community referral for admission, more severe wasting on admission, younger age, and a long commute for treatment.
CONCLUSIONS
To our knowledge, this is the first conventional CMAM program in India and has achieved low mortality and high cure rates in nondefaulting children. The new admission criteria lower the threshold for severity with the result that more children are included who are at lower risk of death and have a smaller WHZ deficit to correct than do children identified by the old criteria. This study was registered as a retrospective observational analysis of routine program data at http://www.isrctn.com as ISRCTN13980582.
Conference Material > Abstract
Burza S, Mahajan R, Edwards T, Shandilya C, Pereira AL, et al.
MSF Scientific Days International 2021: Research. 2021 May 19
INTRODUCTION
Most interventions for community-based management of severe acute malnutrition (CM-SAM) worldwide utilise mid-upper arm circumference (MUAC) <115mm for eligibility and ≥125mm for discharge. However, this discharge criterion is based on very limited evidence, with no data from the Indian subcontinent. India, home to over one-third of malnourished children globally, provides facility-based care based on weight-for-height with no guidelines for CM-SAM. Previous observational data suggests relapse in children reaching ≥120mm is similar to that for ≥125mm, whilst duration of treatment required to achieve ≥125mm is nearly doubled, with higher default rates. This trial in the state of Jharkhand, India investigated whether discharge with MUAC ≥120mm is non-inferior to MUAC ≥125mm for risk of relapse to SAM or death.
METHODS
We conducted a multicentre randomized controlled noninferiority trial for SAM children aged between six and 59 months across 46 centres in Jharkhand, India. Over 12 months, children with MUAC<115mm and without oedema at admission were randomly allocated to be discharged either at MUAC ≥120 mm or MUAC ≥125mm. Endpoints were status at three months (primary) and six months (secondary) after reaching their allocated discharge MUAC. Non-inferiority was concluded if the upper bound (UB) of a one-sided 95% confidence interval was within a pre-defined 13% margin, based on pragmatic operational indicators.
ETHICS
This study was approved by the MSF Ethics Review Board and by the Ethical Review Boards of the Rajendra Institute of Medical Sciences, Ranchi and Jawaharlal Nehru University, New Delhi, India, and London School of Hygiene & Tropical Medicine, UK. Clinical Trials Registry – India number, CTRI/2017/12/010743.
RESULTS
Of 633 children enrolled, 316 were allocated to the standard of care arm (discharge at ≥125mm) and 317 to the ≥120mm arm. No significant clinical-epidemiological differences were detected between cohorts not reaching their allocated discharge MUAC, however there was a higher proportion of treatment non-response (17.5% vs 9%) in the 125mm arm. Of 194 and 236 children reaching discharge criteria in each arm respectively, 176 and 216 were eligible for intention-to-treat analysis. For the standard of care arm, 42% of children were male, with a mean age of 12.6 months (standard deviation, SD; 7.9); for the ≥120mm arm, 41% were male, with a mean age of 12.1 months (SD; 7.1). Overall, non-inferiority was observed within three months; unadjusted risk difference (RD) 6.4%, 95% UB=11.6%, ≥125mm: n=14 (8.0%; 14 relapse, 0 death), ≥120mm: n=31 (14.4%; 30 relapse, 1 death). In pre-specified stratified analyses, non-inferiority was observed in children with MUAC 110-114mm at enrolment (N=285, RD 2.0%, 95% UB 7.5%); however, inferiority was observed with MUAC<110mm (N=107, RD 17.5%, 95% UB 29.0%). In stratified secondary outcome analyses at six months, conclusions were similar.
CONCLUSION
Using a non-inferiority margin of 13%, results support ≥120mm as a discharge criterion in children admitted with MUAC 110-114mm, but not in those with MUAC<110mm. This margin in children discharged earlier needs to be balanced against greater capacity for programmatic coverage. Considering over two thirds of children are admitted with MUAC 110-114mm, defining discharge criteria by admission MUAC may have important implications on increasing capacity and cost-effectiveness of CM-SAM programming in India.
Most interventions for community-based management of severe acute malnutrition (CM-SAM) worldwide utilise mid-upper arm circumference (MUAC) <115mm for eligibility and ≥125mm for discharge. However, this discharge criterion is based on very limited evidence, with no data from the Indian subcontinent. India, home to over one-third of malnourished children globally, provides facility-based care based on weight-for-height with no guidelines for CM-SAM. Previous observational data suggests relapse in children reaching ≥120mm is similar to that for ≥125mm, whilst duration of treatment required to achieve ≥125mm is nearly doubled, with higher default rates. This trial in the state of Jharkhand, India investigated whether discharge with MUAC ≥120mm is non-inferior to MUAC ≥125mm for risk of relapse to SAM or death.
METHODS
We conducted a multicentre randomized controlled noninferiority trial for SAM children aged between six and 59 months across 46 centres in Jharkhand, India. Over 12 months, children with MUAC<115mm and without oedema at admission were randomly allocated to be discharged either at MUAC ≥120 mm or MUAC ≥125mm. Endpoints were status at three months (primary) and six months (secondary) after reaching their allocated discharge MUAC. Non-inferiority was concluded if the upper bound (UB) of a one-sided 95% confidence interval was within a pre-defined 13% margin, based on pragmatic operational indicators.
ETHICS
This study was approved by the MSF Ethics Review Board and by the Ethical Review Boards of the Rajendra Institute of Medical Sciences, Ranchi and Jawaharlal Nehru University, New Delhi, India, and London School of Hygiene & Tropical Medicine, UK. Clinical Trials Registry – India number, CTRI/2017/12/010743.
RESULTS
Of 633 children enrolled, 316 were allocated to the standard of care arm (discharge at ≥125mm) and 317 to the ≥120mm arm. No significant clinical-epidemiological differences were detected between cohorts not reaching their allocated discharge MUAC, however there was a higher proportion of treatment non-response (17.5% vs 9%) in the 125mm arm. Of 194 and 236 children reaching discharge criteria in each arm respectively, 176 and 216 were eligible for intention-to-treat analysis. For the standard of care arm, 42% of children were male, with a mean age of 12.6 months (standard deviation, SD; 7.9); for the ≥120mm arm, 41% were male, with a mean age of 12.1 months (SD; 7.1). Overall, non-inferiority was observed within three months; unadjusted risk difference (RD) 6.4%, 95% UB=11.6%, ≥125mm: n=14 (8.0%; 14 relapse, 0 death), ≥120mm: n=31 (14.4%; 30 relapse, 1 death). In pre-specified stratified analyses, non-inferiority was observed in children with MUAC 110-114mm at enrolment (N=285, RD 2.0%, 95% UB 7.5%); however, inferiority was observed with MUAC<110mm (N=107, RD 17.5%, 95% UB 29.0%). In stratified secondary outcome analyses at six months, conclusions were similar.
CONCLUSION
Using a non-inferiority margin of 13%, results support ≥120mm as a discharge criterion in children admitted with MUAC 110-114mm, but not in those with MUAC<110mm. This margin in children discharged earlier needs to be balanced against greater capacity for programmatic coverage. Considering over two thirds of children are admitted with MUAC 110-114mm, defining discharge criteria by admission MUAC may have important implications on increasing capacity and cost-effectiveness of CM-SAM programming in India.
Conference Material > Slide Presentation
Mahajan R, Edwards T, Shandilya C, Kashyap V, Marino E, et al.
MSF Scientific Days International 2021: Research. 2021 May 19
Journal Article > LetterFull Text
Am J Clin Nutr. 2015 November 1; Volume 102 (Issue 5); DOI:10.3945/ajcn.115.117267
Burza S, Mahajan R, Marino E, Sunyoto T, Matthew P, et al.
Am J Clin Nutr. 2015 November 1; Volume 102 (Issue 5); DOI:10.3945/ajcn.115.117267
Other > Journal Blog
Field Exch. 2017 March 6
Tapié de Céleyran F, Hanson KE, Ferreyra C, Salse NKS, Tshialala D, et al.
Field Exch. 2017 March 6