Malaria, malnutrition Nutritional, Metabolic, Endocrine Malaria, malnutrition
Conditions
Interventions
1. Once each month for four consecutive months, eligible children in the SMC-only group will receive co-blistered packs of sulfadoxine plus amodiaquine to be taken over 3 days (3 to <12 months dose pa
12–59 months dose pack contains one tablet of 525 mg sulfadoxine plus three tablets of 150 mg each of amodiaquine).
2. Once each month for the same four consecutive months, eligible ch
Sponsors
Clinton Health Access Initiative
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: SMC delivery: 1. Age 3–59 months old at the first distribution round 2. Residing in either intervention area LNS delivery: 1. Age 6–24 months old at the first distribution round or 6 months of age before the distribution round 2, 3, or 4 2. Residing in the LNS-distribution intervention area 3. Parental informed consent Nutrition indicators: 1. Aged 6–24 months old in both arms: SMC and SMC + LNS 2. SMC coverage will be analysed across the entire cohort of children who received SMC: 3–59 months old 3. LNS coverage will be analysed in children aged 6–24 months old in the SMC+LNS arm Nested case-control study-specific (hypothesis 3) cases: 1. Presenting to an enrolled health facility between 27/08/2014 and 31/12//2014 with an axillary temperature of =37.5°C or a history of fever in the previous 48 hours and have parasitologically confirmed malaria by either rapid diagnostic test or microscopy 2. Age 6-24 months old at the first distribution round or 6 months old before distribution round 2, 3, or 4 3. Residing in an intervention area 4. Parental or guardian's informed consent (for parents or guardians who are between the ages of 12–18, they must provide informed assent and if their parent or guardian is nearby, this parent or guardian must also provide informed consent) 5. Meet eligibility requirements for SMC or SMC + LNS delivery depending on intervention area residence Nested case-control study-specific (hypothesis 3) control: 1. Presenting to an enrolled health facility between 27/08/2014 and 31/12/2014 for febrile illness within the same week of the case and test negative for malaria by either rapid diagnostic test or microscopy 2. Residing in the same ward as the case 3. Age 6–24 months old at the first distribution round or 6 months old before distribution rounds 2, 3, or 4 4. Parental or guardian's informed consent (for parents or guardians who are between the ages of 12–18, they must provide informed assent and if their parent or guardian is nearby, this parent/guardian must also provide informed consent form) 5. Meet eligibility requirements for SMC or SMC + LNS delivery depending on intervention area residence
Exclusion criteria
Exclusion criteria: SMC delivery: 1. Age 59 months old at the first distribution round 2. Severe acute illness 3. Unable to take oral medication 4. Confirmed malaria is defined as fever (body temperature of at least 37.5°C) or history of fever in the past 24 hours and parasitologically positive by rapid diagnostic test or microscopy; in the absence of rapid diagnostic test and microscopy diagnosis, malaria diagnosis should be based on clinical signs and symptoms 5. Human immunodeficiency virus (HIV)-positive and taking co-trimoxazole 6. Received a dose of sulfadoxine or pyrimethamine more recently than the past month 7. Allergic to sulfadoxine or pyrimethamine LNS Delivery: 1. Age 24 months old at the first distribution round 2. Diagnosis of severe acute malnutrition as defined by mean upper arm circumference 24 months at time of first distribution 3. Not residing in an intervention area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. SMC coverage (hypothesis 1): percentage of eligible children 3–59 months old who receive SMC during the distribution (in child months); will be measured at 3 months 2. SMC adherence (hypothesis 1): percentage of eligible children who complete the 3 day treatment course of SMC out of the total number of children who receive SMC during the final month of distribution; will be measured at 3 months 3. Nutritional status (hypothesis 2): mean height-for-age, weight-for-age and weight-for-length z-scores (WHO 2006 Growth Standards) in the SMC + LNS versus SMC-only communities; will be measured at baseline, 3 months and 9 months 4. Nested case-control study-specific clinical malaria incidence (hypothesis 3): difference in the odds of uncomplicated malaria illness (confirmed cases presenting at enrolled health facilities) in children 6–24 months old compared with matched cases and controls in the SMC only and SMC + LNS groups; will be measured after the recruitment period for the nested study ends on 31/12/2014 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SMC coverage in the group directly receiving LNS (6–24 months); will be measured at 3 months 2. Prevalence of malnutrition in SMC/LNC versus SMC-only communities (all using WHO growth standards); will be measured at baseline, 3 months and 9 months 2.1. Percentage of stunting (<-2 z-scores length-for-age) and percentage of severe stunting (<-3 z-scores) 2.2. Percentage of underweight (<-2 z-scores weight-for-age) and percentage of severe underweight(<-3 z-scores) 2.3. Percentage of wasting (<-2 z-scores weight-for-length) and percentage of severe wasting (<-3 z-scores) and percentage of severe acute malnutrition (severe wasting and/or mid-upper arm circumference <115 mm and/or oedema) 3. Malnutrition stratified by household food security status (an effect of the intervention may only be observed in the most food insecure households); will be measured at baseline, 3 months and 9 months 4. Severe malaria incidence: difference in the odds of hospital admissions for severe malaria per 1000 children 6–24 months old in the health facility catchment area comparing cases and controls in the SMC only and SMC + LNS groups; will be measured after the recruitment period for the nested study ends on 31/12/2014 Related studies will assess: 1. Cost-effectiveness; will be measured at 3 months 2. Reasons for coverage/non-coverage of SMC and LNS (quantitative, surveys, and qualitative, focus group discussions); will be measured at 3 months 3. Community drug distributor experiences (qualitative, focus group discussions); will be measured at 3 months | — |
Countries
Nigeria
Outcome results
None listed