Comparing Azithromycin to Amoxicillin in the Management of Uncomplicated Severe Acute Malnutrition in Burkina Faso: A Pilot Randomized Trial

Azithromycin is a promising alternative to amoxicillin in the management of uncomplicated severe acute malnutrition (SAM) as it can be administered as a single dose and has efficacy against several pathogens causing infectious disease and mortality in children under 5. In this pilot trial, we aimed to establish the feasibility of a larger randomized controlled trial and provide preliminary evidence comparing the effect of azithromycin to amoxicillin on weight gain in children with uncomplicated SAM. We enrolled children 6–59 months old with uncomplicated SAM at six healthcare centers in Burkina Faso. Participants were randomized to a single dose of azithromycin or a 7-day course of amoxicillin and followed weekly until nutritional recovery and again at 8 weeks. Apart from antibiotics, participants received standard of care, which includes ready-to-use therapeutic food. Primary feasibility outcomes included enrollment potential, refusals, and loss to follow-up. The primary clinical outcome was weight gain (g/kg/day) over 8 weeks. Outcome assessors were masked. Between June and October 2020, 312 children were screened, 301 were enrolled with zero refusals, and 282 (93.6%) completed the 8-week visit. Average weight gain was 2.5 g/kg/day (standard deviation [SD] 2.0) in the azithromycin group and 2.6 (SD 1.7) in the amoxicillin group (mean difference −0.1, 95% CI −0.5 to 0.3, P = 0.63). Fewer adverse events were reported in the azithromycin group (risk ratio 0.50, 95% CI 0.31–0.82, P = 0.006). With strong enrollment and follow-up, a fully powered trial in this setting is feasible.

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Comparing azithromycin to amoxicillin in the management of uncomplicated severe acute malnutrition in Burkina Faso: a pilot randomized trial

10.1101/2021.06.15.21258967 ◽

2021 ◽

Author(s):

Kieran S O'Brien ◽

Ali Sié ◽

Clarisse Dah ◽

Millogo Ourohire ◽

Moussa Ouédraogo ◽

...

Keyword(s):

Single Dose ◽

Weight Gain ◽

Adverse Events ◽

Burkina Faso ◽

Randomized Trial ◽

Severe Acute Malnutrition ◽

Acute Malnutrition ◽

World Health ◽

Promising Alternative

Introduction. Given the potential for asymptomatic infection in children with uncomplicated severe acute malnutrition (SAM), the World Health Organization recommends a broad-spectrum antibiotic like amoxicillin. Azithromycin is a promising alternative to amoxicillin as it can be administered as a single dose and has efficacy against several pathogens involved in the burden of infectious disease and mortality in this population. In this pilot study, we aimed to establish the feasibility of a larger randomized controlled trial and to provide preliminary evidence comparing the effect of azithromycin to amoxicillin on weight gain in children with uncomplicated SAM. Methods. This pilot randomized trial enrolled children 6-59 months old with uncomplicated SAM at 6 healthcare centers in Burkina Faso. Participants were randomized to a single dose of azithromycin or a 7-day course of amoxicillin. All participants received ready-to-use therapeutic food and were followed weekly until nutritional recovery and again at 8 weeks. The primary feasibility outcomes included enrollment potential, refusals, and loss to follow-up. The primary clinical outcome was weight gain (g/kg/day) over the 8-week period. Outcome assessors were masked. Results. Between June and October 2020, 312 children were screened, 301 were enrolled with 0 refusals, and 282 (93.6%) completed the 8-week visit. Average weight gain was 2.5 g/kg/day (SD 2.0) in the azithromycin group and 2.6 (SD) 1.7) in the amoxicillin group (Mean Difference -0.1, 95% CI -0.5 to 0.3, P = 0.63). Fewer adverse events were reported in the azithromycin group (Risk Ratio 0.50, 95% CI 0.31 to 0.82, P = 0.006). Conclusions. No differences were found in weight gain between groups. Given the ability to administer a single dose and the potential for fewer adverse events, azithromycin may be an alternative to amoxicillin for uncomplicated SAM. With strong enrollment and follow-up, a larger trial in this setting is feasible.

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Study to determine gender variation in severe acute malnutrition at nutrition rehabilitation centre

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20190695 ◽

2019 ◽

Vol 6 (2) ◽

pp. 602

Author(s):

Suguna S. ◽

Vidyasagar V.

Keyword(s):

Weight Gain ◽

District Hospital ◽

Severe Acute Malnutrition ◽

Acute Malnutrition ◽

Rehabilitation Centre ◽

Gender Variation ◽

Nutrition Rehabilitation ◽

Time Of Admission ◽

Discharge Criteria

Background: The objective of this study is to know the gender variation in number of admissions, severity of malnutrition at the time of admission, gaining of weight and adherence to follow up in children admitted to nutrition rehabilitation center and during follow up.Methods: This is a retrospective study involving the review of existing programme records. Children who were admitted to nutrition rehabilitation centre, district hospital, Chamarajanagar, Karnataka, India, between January 2017 to December 2017 with severe acute malnutrition were involved in the study. The programme included 2 weeks of in-patient care, and four follow-up visits to the NRC subsequently as follows; 1st visit at 7 days, 2nd at 14 days, 3rd at 1 month and 4th at 2 months after discharge.Results: Among 57 children who admitted to NRC females were 30 (52.6%) and males 27 47.4%). 25 among 57 children (43.9%) could sustain weight gain of >5grams/kg/day as per one of the discharge criteria. 13 (52%) were females and 12 (48%) were males. 32(56%) among 57 admitted children to NRC, could achieve <-1SD during entire programmed. 15(46.8%) were females and 17 (53.1%) were males.Conclusions: There was no gender variation in either number of admission or severity of malnutrition at the time of admission or weight gain during NRC programme.

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Single-dose azithromycin for child growth in Burkina Faso: a randomized controlled trial

BMC Pediatrics ◽

10.1186/s12887-021-02601-7 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Ali Sié ◽

Boubacar Coulibaly ◽

Clarisse Dah ◽

Mamadou Bountogo ◽

Mamadou Ouattara ◽

...

Keyword(s):

Single Dose ◽

Weight Gain ◽

Burkina Faso ◽

Controlled Trial ◽

Population Sample ◽

Child Growth ◽

Mean Difference ◽

Antibiotic Administration ◽

Linear Regression Models ◽

Randomized Controlled

Abstract Background In lower resource settings, previous randomized controlled trials have demonstrated evidence of increased weight gain following antibiotic administration in children with acute illness. We conducted an individually randomized trial to assess whether single dose azithromycin treatment causes weight gain in a general population sample of children in Burkina Faso. Methods Children aged 8 days to 59 months were enrolled in November 2019 and followed through June 2020 in Nouna Town, Burkina Faso. Participants were randomly assigned to a single oral dose of azithromycin (20 mg/kg) or matching placebo. Anthropometric measurements were collected at baseline and 14 days and 6 months after enrollment. The primary anthropometric outcome was weight gain velocity in g/kg/day from baseline to 14 days and 6 months in separate linear regression models. Results Of 450 enrolled children, 230 were randomly assigned to azithromycin and 220 to placebo. Median age was 26 months (IQR 16 to 38 months) and 51% were female. At 14 days, children in the azithromycin arm gained a mean difference of 0.9 g/kg/day (95% CI 0.2 to 1.6 g/kg/day, P = 0.01) more than children in the placebo arm. There was no difference in weight gain velocity in children receiving azithromycin compared to placebo at 6 months (mean difference 0.04 g/kg/day, 95% CI − 0.05 to 0.13 g/kg/day, P = 0.46). There were no significant differences in other anthropometric outcomes. Conclusions Transient increases in weight gain were observed after oral azithromycin treatment, which may provide short-term benefits. Clinical trials registration ClinicalTrials.gov NCT03676751. Registered 19/09/2018.

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Etiological factors of severe acute malnutrition and impact of nutrition rehabilitation centre: a prospective observational study from Bhavnagar

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20211072 ◽

2021 ◽

Vol 8 (4) ◽

pp. 652

Author(s):

Vibhuti D. Gamit ◽

Jayendra R. Gohil ◽

Adithya Nikhileshwar B. ◽

Tanmay P. Vagh

Keyword(s):

Weight Gain ◽

Observational Study ◽

Prospective Observational Study ◽

Severe Acute Malnutrition ◽

Birth Spacing ◽

Acute Malnutrition ◽

Rehabilitation Centre ◽

Etiological Factors ◽

Nutrition Rehabilitation

Background: Severe acute malnutrition (SAM) causes almost half of childhood deaths in children <5 years in developing countries. In India, as National Family Health Survey (NFHS), prevalence of SAM has increased from 6.4 in NFHS-3 (2005-2006) to 7.5% in NFHS-4 (2015-1016); [5.8 to 9.5% Gujarat]. The aim of study was to determine the etiological factors and outcome of SAM and the benefit of nutrition rehabilitation centre (NRC) among 6 months to 5 years children at the Pediatrics, NRC ward, Sir T. General Hospital.Methods: A prospective observational study of 151 SAM children over nine months. Etiological factors were determined by history and relevant investigations, exclude other systemic disorders. Therapeutic nutrition was provided for 14 days. Cases were followed up two weekly for 2 months by monitoring weight after NRC admission.Results: Association was found between Small for gestational age (64.9%), joint family (59.6%) and low birth spacing (59.6%) as etiological factors leading to SAM. 81.5% children gained weight during 14 days NRC stay. Weight gain was noted at follow-up. Defaulter rate increased from 9.9% at discharge to 28.5% at 2 months follow-up. Weight was static for 9% children. 34.4% children were from rural area and 65.6% from urban area. 23.8% children had received pre lacteal feed. Timing of complementary feeding was incorrect in 29%. There were no deaths.Conclusions: Small for gestational age, joint family, low birth spacing, and incorrect feeding practices and urban residence were etiological factors. NRC stay (defaulter rate 26%), produced weight gain in SAM children.

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A study of effectiveness of nutritional interventions on children with severe acute malnutrition admitted in nutrition rehabilitation centers of Bhopal, Madhya Pradesh

International Journal of Community Medicine and Public Health ◽

10.18203/2394-6040.ijcmph20182200 ◽

2018 ◽

Vol 5 (6) ◽

pp. 2590

Author(s):

D. M. Saxena ◽

Akshat Pathak ◽

Ganga Ram Mahor ◽

Ramniwas Mahor ◽

Anil Agarwal

Keyword(s):

Severe Acute Malnutrition ◽

Madhya Pradesh ◽

Acute Malnutrition ◽

Severe Malnutrition ◽

Average Weight ◽

Full Potential ◽

Health Issues ◽

Significant Difference ◽

Nutrition Rehabilitation

Background: The prevalence of under-nutrition among under-five children is high and varies widely. Children with severe acute malnutrition require immediate attention along with proper nutritional rehabilitation not only to decrease mortality but also to achieve full potential after recovery. Nutrition rehabilitation centres (NRCs) were started to control severe malnutrition and decrease the prevalence of severe malnourished children to less than 1% among children aged 1–5 years.Methods: The present study was conducted from July 2016 to June 2017; 500 children admitted to five different NRCs in Bhopal district of Madhya Pradesh were observed during their stay at NRCs and children were followed up during a period of 6 months after discharge from NRCs. Mothers of the children were interviewed on various health issues of children and feeding practices at the NRCs using a predesigned and pretested interview schedule.Results: The study group consisted of 252 boys and 248 girls; 51.20% were between 13 and 36 months of age. All 500 children were analysed for anthropometric indicators. A statistically significant difference was obtained between the weight of children at admission, discharge and follow up (ANOVA=106.2, p<0.001); difference of mid upper arm circumference (MUAC) at admission, discharge and follow up was also statistically significant (ANOVA=24.02, p<0.001). The average weight gain during the stay at the centers was 8.95±3.59 g/kg/day. The mothers of the children lacked adequate information on health issues and composition and preparation of nutrient rich diets for their children.Conclusions: The NRCs were effective in improving the condition of admitted children, but the effects were not well sustained following discharge due to lack of adequate parental awareness and action.

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Locally prepared ready to use therapeutic food for the treatment of children with severe acute malnutrition: a randomized controlled trial

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20172692 ◽

2017 ◽

Vol 4 (4) ◽

pp. 1491

Author(s):

Ravichandra K. R. ◽

Narendra Behera

Keyword(s):

Weight Gain ◽

Hospital Stay ◽

Severe Acute Malnutrition ◽

Controlled Trial ◽

Acute Malnutrition ◽

Study Cohort ◽

Rapid Weight Gain ◽

Duration Of Hospital Stay ◽

Significant Difference ◽

Therapeutic Food

Background: Severe acute malnutrition (SAM) remains as one of the major killers of children under five years of age. As per WHO are guidelines, dietary management plays a big role in the longer rehabilitation phase of management of SAM. RUTFs are now being used as a substitute to F-100 diet in the management of SAM around the globe. The objective of the study was to compare the efficacy of locally-prepared ready-to-use therapeutic food (LRUTF) and F-100 diet in promoting weight-gain in children with SAM.Methods: A total of 120 children were included in the study. The control cohort received F-100 while the study cohort received LRUTF diet. Both the groups received a total of 6 feeds per day which included 3 feeds of either LRUTF or F100 and 3 feeds from family pot. Outcome was measured in terms of Rate of weight gain/kg/day, duration of hospital stays and recovery rates.Results: There were 60 subjects in each group. Rate of weight gain was found to be (9.15±3.39 gm/kg/day) in LRUTF group and (6.72±1.05 gm/kg/day) in F-100 group. Significant difference in rate of weight gain was observed in LRUTF group. Duration of hospital stay was lesser in LRUTF group than F-100 group... Recovery rates in LRUTF group were better than F-100 group.Conclusions: LRUTF promotes more rapid weight-gain when compared with F100 in patients with SAM during rehabilitation phase. Duration of hospital stay is lesser in LRUTF group than that of F-100 group.

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An experience of facility based management at one of the malnutrition treatment centre in district Baran of Rajasthan, India

International Journal of Community Medicine and Public Health ◽

10.18203/2394-6040.ijcmph20172195 ◽

2017 ◽

Vol 4 (6) ◽

pp. 2162

Author(s):

Shakila Mulla ◽

Pankaj Kumar Gupta

Keyword(s):

Weight Gain ◽

Length Of Stay ◽

Performance Indicators ◽

Death Rate ◽

Severe Acute Malnutrition ◽

Acute Malnutrition ◽

Age Group ◽

Treatment Centre

Background: To assess performance of one of the Malnutrition Treatment Centre (MTC) in district Baran of Rajasthan. India. Methods: An observational prospective study was conducted at MTC where 132 Severe Acute Malnutrition (SAM) children were recruited. Their socio-demographic details and anthropometric measurements were recorded. These SAM children were followed till the period of 4 follow-up visits to measure their weight. MTC performance indicators were assessed. Results: Majority of SAM children belong to age group less than 2 years, gender female, caste OBC (Other Backward Class), SC (Scheduled Caste) and ST (Scheduled Tribe). ASHAs (Accredited Social Health Activists) are playing key role in referring them to MTC. Death rate was 0%, cure (recovery) rate 42.4%, defaulter rate 25.8%, mean length of stay (days) at MTC was 8.04 and mean weight gain was 5.926 g/kg/day. Performance indicators are significantly affected by length of stay at MTC. Follow-up rate was poor with no significant weight gain observed after discharge. Conclusions: MTCs are effective in saving lives of SAM children but not in maintaining long term control on malnutrition.

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Response to gluten free diet in sero-positive celiac disease children suffering from severe acute malnutrition in age group 1-5 years

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20191440 ◽

2019 ◽

Vol 6 (3) ◽

pp. 1090

Author(s):

Mahendra Meena ◽

Pradeep Meena ◽

R. L. Suman ◽

Suresh Goyal

Keyword(s):

Celiac Disease ◽

Weight Gain ◽

Severe Acute Malnutrition ◽

Gluten Free Diet ◽

Acute Malnutrition ◽

P Value ◽

Age Group ◽

Gluten Free ◽

Group 1

Background: Diagnosis of celiac disease in children suffering from severe acute malnutrition without duodenal biopsy or HLA typing is a dilemma. The objective of this study was to study the response to gluten free diet in sero-positive Celiac Disease children suffering from severe acute malnutrition in age group 1-5 years.Methods: This prospective, observational, hospital-based study was conducted at MTC of tertiary care medical college hospital of southern Rajasthan from Dec. 2017 to Nov. 2018. Total 110 children with SAM were enrolled and screened for celiac disease on the basis of tissue tTg-IgA/IgG serology. Seropositive cases were kept on gluten free diet for short period of time and observed for the resolution of symptoms and improvement in growth, monitored by anthropometry on discharge and follow up visit.Results: Mean weight gain (gm/kg/day) on follow up was 3.87±3.49 in seropositive and 1.88±3.79 in seronegative cases (P-value<0.05). Mean weight gain was 6.43±3.28gm/kg/day in only tTg-IgA positive and 3.04±2.95 gm/kg/day in only tTg-IgG positive cases (P-value-<0.05). The mean weight gain in strictly gluten free adherent sero-positive cases was 4.89±2.97 gm/kg/day while in gluten free non-adherent patients it was -0.49±1.70 (P-value <0.001). Mean weight gain in probable (tTg-Ig-A <10 times ULN) and presumptive (tTg-IgA >10 times ULN) Celiac disease were 3.44±3.73 and 5.44±3.78, respectively without statically significant difference (P-value >0.05).Conclusions: In situations where facility of duodenal biopsy and or HLA DQ2/DQ8 typing is not available, resolution of symptoms and improvement in growth on gluten free diet confirms the diagnosis of celiac disease.

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Etiological Factors of Severe Acute Malnutrition (SAM) and Impact of Nutrition Rehabilitation Centre: a prospective observational study from Bhavnagar, Gujarat, India

10.31219/osf.io/cb26d ◽

2020 ◽

Author(s):

Vibhuti Gamit ◽

Jayendra Ratilal Gohil

Keyword(s):

Weight Gain ◽

Observational Study ◽

Prospective Observational Study ◽

Severe Acute Malnutrition ◽

Birth Spacing ◽

Acute Malnutrition ◽

Rehabilitation Centre ◽

Etiological Factors ◽

Nutrition Rehabilitation

Introduction Severe acute malnutrition (SAM) is a cause of almost half of childhood deaths in children < 5 years in developing countries. In India, as National Family Health Survey (NFHS), prevalence of SAM has increased from 6.4 in NFHS-3 (2005-6) to 7.5% in NFHS-4 (2015-16); [5.8 to 9.5% Gujarat]. The aim of study was to determine the etiological factors and outcome of SAM and the benefit of nutrition rehabilitation centre (NRC) among 6 months to 5 years children at the Pediatrics Dept, Sir T General Hospital, Bhavnagar. Methods A prospective observational study of 151 SAM children over nine months. Etiological factors were determined by history and relevant investigations, exclude other systemic disorders. Therapeutic nutrition was provided for 14 days. Cases were followed up two weekly for 2 months by monitoring weight after NRC admission. Results Association was found between Small for gestational age (64.9%), joint family (59.6%) and low birth spacing (59.6%) as etiological factors leading to SAM. 81.5% Children gained weight during14 days NRC stay. Weight gain was noted at follow-up. Defaulter rate increased from 9.9% at discharge to 28.5% at 2 months follow-up. Weight was static for 9% children. 34.4% children were from rural area and 65.6% from urban area. 23.8% children had received pre lacteal feed. Timing of complementary feeding was incorrect in 29%. There were no deaths. Conclusion Small for gestational age, joint family, low birth spacing, incorrect feeding practices and urban residence were etiological factors. NRC stay (defaulter rate 26%), produced weight gain in SAM children.

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MANAGEMENT OF INFANTS LESS THAN SIX MONTHS WITH SEVERE ACUTE MALNUTRITION (SAM).

The Professional Medical Journal ◽

10.29309/tpmj/2020.27.06.3386 ◽

2020 ◽

Vol 27 (06) ◽

pp. 1113-1118

Author(s):

Saadia Khan ◽

Gul Hasan ◽

Ibad Ali ◽

Reema Arshad ◽

Imrana Ali ◽

...

Keyword(s):

Weight Gain ◽

Breast Feeding ◽

Maternal Education ◽

Severe Acute Malnutrition ◽

National Level ◽

Acute Malnutrition ◽

Daily Weight Gain ◽

Average Weight ◽

Breast Feed ◽

Study Results

Objectives: To determine the average weight gain after lactation counseling therapy in infants up to six months of age having severe acute malnutrition. Study Design: Quasi experimental trial. Setting: Stabilization Center Unit, the Children’s Hospital & the Institute of Child Health, Multan. Period: 1st October 2015 to 1st October 2016. Material & Methods: A total of 205 children with SAM were included in this study using non-probability consecutive sampling technique. Mothers of these children were motivated for more than 8 feeds/day, positioning and attachment at breast feeding was advised, demonstrated and monitored. All the data obtained was entered and analyzed by SPSS version 20. Results: Of these 205 study cases, 142 (69.3%) were boys and 63 (30.75) were girls. Mean age of our study cases was 3.75 ± 1.39 months (with minimum age of our study cases was 2 months while maximum age was 6 months). Of these 205 study cases, 101 (49.3 %) were from rural areas while 104 (50.7%) were from urban areas. Mothers of 117 (57.1%) study cases were literate while 88 (42.9%) were illiterate. Majority of our study cases i.e. 129 (62.9%) were from middle income background and 76 (37.1%) were from poor social background. Partial breast feeding was positive in 145 (70.7%) of our study cases and no breast feeding was noted in 60 (29.3%). Mean baseline weight was 2737.07± 585.60 grams. Mean weight at discharge was 2995.37 ± 621.97 grams and mean weight gain was 800.0 ± 258. 29 grams. Average daily weight gain was noted to be 11.27 ± 4.73 g/kg/day. Conclusion: Our study results have shown that lactation counseling therapy significantly improves weight gain in children under 6 months of age with severe acute malnutrition. Mothers of infants presenting with malnutrition must be counselled to breast feed to improve their clinical outcomes. Mean weight gain was significantly associated with maternal education and socioeconomic status. Further studies are suggested from different parts of the country to generate our local data at national level which may be incorporated for national health policy guidelines.

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