ISRCTN53213318进行中（未招募）Unknown
A multi-country, multi-centre, three-arm, parallel-group, open-label, randomized trial of three supplements for the nutritional management of moderate wasting in children 6-24 months of age with acute illness
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 6,360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 6-24 months
- •2. Moderately wasted i.e. WLZ =-2 and > -3 or MUAC <125 mm and >115 mm
- •3. Presenting with any of the following acute illnesses at a facility out-patient clinic or discharged from hospital after <7 days for any of the following:
- •3.1. Diarrhea, defined as three or more loose or watery stools (with or without blood) in the previous 24 hours, and no dehydration on assessment. If the child has dehydration, the dehydration will be treated re-assessing for recruitment, or
- •3.2. Pneumonia, defined as the presence before of fast breathing or chest indrawing, or
- •3.3. Non-malarial fever, defined as reported or measured (=38?C) fever of >3 days but <7 days duration
- •[Acute illness in the context of this trial: Children with significant acute illness are at higher risk for severe outcomes like risk of developing SAM or hospitalization/death. Decreasing the risk in these children is important. Therefore, acute illness in this trial will be defined as diarrhea, signs of pneumonia, malaria or fever. If fever, then this should be present for >3 days duration. Milder illnesses, for example, skin or common cold/ cough will not be considered as significant acute illness as having these mild illnesses are less likely to cause children to enter a downward spiral of increased risk of morbidity/mortality]
- •3.4. malaria, defined as reported or measured (=38?C) fever and positive rapid diagnostic test, or
- •4. Consent for study participation from parent or legal guardian
排除标准
- •Current exclusion criteria as of 28/03/2024:
- •1. Severe acute malnutrition (WLZ <-3 or MUAC <115 mm or oedema of both feet)
- •2. General danger signs (lethargic/unconscious, convulsions, unable to drink, vomits everything)
- •3. Severe illness (severe pneumonia or very severe disease, severe dehydration, neck stiffness)
- •4. Persistent diarrhoea (=14 days)
- •5. Chronic infections/illness or disability, e.g. TB, HIV, congenital defects, cerebral palsy
- •6. Require hospital admission
- •7. Well child attended clinic only for routine growth monitoring or immunization
- •8. Child receiving food supplements for moderate wasting
- •9. Treated for moderate wasting in the previous 3 months
- •10. Previously enrolled in the study
- •11. Child with any known history of food allergy or food intolerance
- •12. Another child in the same household already recruited into the study
- •13. Child lives outside the study area routinely or will be outside of the study area for more than two weeks in the upcoming 3 months.
- •Previous exclusion criteria:
- •1. Severe acute malnutrition (WLZ <-3 or MUAC <115 mm or oedema of both feet)
- •2. General danger signs (lethargic/unconscious, convulsions, unable to drink, vomits everything)
- •3. Severe illness (severe pneumonia or very severe disease, severe dehydration, neck stiffness)
- •4. Persistent diarrhoea (=14 days)
- •5. Chronic infections/illness or disability, e.g. TB, HIV, congenital defects, cerebral palsy
- •6. Require hospital admission
- •7. Well child attended clinic only for routine growth monitoring or immunization
- •8. Child receiving food supplements for moderate wasting
- •9. Treated for moderate wasting in the previous 3 months
- •10. Previously enrolled in the study
- •11. Child with any known history of food allergy or food intolerance
- •12. Another child in the same household already recruited into the study
- •13. Child lives outside the study area
研究者
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