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.
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.
Journal Article > ResearchFull Text
BMC Nutr. 2019 July 2; Volume 5; 35.; DOI:0.1186/s40795-019-0299-2
Chaand I, Horo M, Nair MM, Harshana A, Mahajan R, et al.
BMC Nutr. 2019 July 2; Volume 5; 35.; DOI:0.1186/s40795-019-0299-2
BACKGROUND
This study aims to investigate the knowledge, perception and practices related to health, nutrition, care practices, and their effect on nutrition health-seeking behaviour.
METHODS
In order to have maximum representation, we divided Chakradharpur block in Jharkhand state into three zones (north, south and centre regions) and purposively selected 2 Ambulatory Therapeutic Feeding Centre (ATFC) clusters from each zone, along with 2 villages per ATFC (12 villages from 6 ATFCs in total). In-depth interviews and natural group discussions were conducted with mothers/caregivers, frontline health workers (FHWs), Medicins Sans Frontieres (MSF) staff, community representatives, and social leaders from selected villages.
RESULTS
We found that the community demonstrates a strong dependence on traditional and cultural practices for health care and nutrition for newborns, infants and young children. Furthermore, the community relies on alternative systems of medicine for treatment of childhood illnesses such as malnutrition. The study indicated that there was limited access to and utilization of local health services by the community. Lack of adequate social safety nets, limited livelihood opportunities, inadequate child care support and care, and seasonal male migration leave mothers and caregivers vulnerable and limit proper child care and feeding practices. With respect to continuum of care, services linking care across households to facilities are fragmented. Limited knowledge of child nutrition amongst mothers and caregivers as well as fragmented service provision contribute to the limited utilization of local health services. Government FHWs and MSF field staff do not have a robust understanding of screening methods, referral pathways, and counselling. Additionally, collaboration between MSF and FHWs regarding cases treated at the ATFC is lacking, disrupting the follow up process with discharged cases in the community.
CONCLUSIONS
For caregivers, there is a need to focus on capacity building in the area of child nutrition and health care provision post-discharge. It is also recommended that children identified as having moderate acute malnutrition be supported to prevent them from slipping into severe acute malnutrition, even if they do not qualify for admission at ATFCs. Community education and engagement are critical components of a successful CMAM program.
This study aims to investigate the knowledge, perception and practices related to health, nutrition, care practices, and their effect on nutrition health-seeking behaviour.
METHODS
In order to have maximum representation, we divided Chakradharpur block in Jharkhand state into three zones (north, south and centre regions) and purposively selected 2 Ambulatory Therapeutic Feeding Centre (ATFC) clusters from each zone, along with 2 villages per ATFC (12 villages from 6 ATFCs in total). In-depth interviews and natural group discussions were conducted with mothers/caregivers, frontline health workers (FHWs), Medicins Sans Frontieres (MSF) staff, community representatives, and social leaders from selected villages.
RESULTS
We found that the community demonstrates a strong dependence on traditional and cultural practices for health care and nutrition for newborns, infants and young children. Furthermore, the community relies on alternative systems of medicine for treatment of childhood illnesses such as malnutrition. The study indicated that there was limited access to and utilization of local health services by the community. Lack of adequate social safety nets, limited livelihood opportunities, inadequate child care support and care, and seasonal male migration leave mothers and caregivers vulnerable and limit proper child care and feeding practices. With respect to continuum of care, services linking care across households to facilities are fragmented. Limited knowledge of child nutrition amongst mothers and caregivers as well as fragmented service provision contribute to the limited utilization of local health services. Government FHWs and MSF field staff do not have a robust understanding of screening methods, referral pathways, and counselling. Additionally, collaboration between MSF and FHWs regarding cases treated at the ATFC is lacking, disrupting the follow up process with discharged cases in the community.
CONCLUSIONS
For caregivers, there is a need to focus on capacity building in the area of child nutrition and health care provision post-discharge. It is also recommended that children identified as having moderate acute malnutrition be supported to prevent them from slipping into severe acute malnutrition, even if they do not qualify for admission at ATFCs. Community education and engagement are critical components of a successful CMAM program.
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