ISRCTN11413895已完成未知
Packaging lipid-based nutritional supplements together with seasonal malaria chemoprevention in a community-based pragmatic trial: effects on seasonal malaria chemoprevention coverage, child nutrition and health in Kano state, northern Nigeria
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 12,000
研究概览
简要总结
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30682069 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •SMC delivery:
- •1. Age < 3 or > 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 < 3 or > 24 months old at the first distribution round
- •2. Diagnosis of severe acute malnutrition as defined by mean upper arm circumference <11.5 cm
- •3. Allergy to peanuts
- •Nested case-control study-specific (hypothesis 3) case or control:
- •1. Age < 6 months old at the time of presentation to health facility
- •2. Age > 24 months at time of first distribution
- •3. Not residing in an intervention area
研究者
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