NCT06056089招募中不适用
Safety Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-use Therapeutic and Supplementary Foods for the Treatment of Moderate Acute Malnutrition Among Children 6-59 Months of Age in Ethiopia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 4
- 主要终点
- short-term nutritional recovery from MAM
研究概览
简要总结
Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. Two fixed-dose regimes of RUTF will be tested against the current fixed-dose regimen of RUSF for children with MAM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-59 months
- •Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year
- •Uncomplicated moderate acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility
- •Pass appetite test conducted at the time of enrollment
- •Consent for randomization into the study given by mother, father, and/or other primary caregiver
- •Mid-upper arm circumference of 115-124 mm without nutritional edema
- •Weight-for-height Z-score (WHZ) between -2 and -3
排除标准
- •Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation
- •Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months
- •Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food
结局指标
主要结局
short-term nutritional recovery from MAM
时间窗: up to 16 weeks
two consecutive weeks with MUAC \> 12.4 cm and/or WHZ \>= -2, depending on enrollment criteria
次要结局
- duration of treatment required prior to short-term recovery(weekly for up to 16 weeks)
- length/height gain during treatment(weekly for up to 16 weeks)
- changes to extracellular water (ECW) as measured by bioelectrical impedance analysis(up to weekly for up to 16 weeks)
- medium-term rates of relapse to SAM(up to 6 months post-recovery)
- medium-term length/height gain(6 months post-recovery)
- medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis(6 months post-recovery)
- weight gain during treatment(weekly for up to 16 weeks)
- changes to fat free mass as measured by bioelectrical impedance analysis(up to weekly for up to 16 weeks)
- hospitalization rate(weekly for up to 16 weeks)
- medium-term mortality rate(up to 6 months post-recovery)
- medium-term MUAC gain(6 months post-recovery)
- medium-term phase angle (PhA) as measured by bioelectrical impedance analysis(6 months post-recovery)
- medium-term fat free mass as measured by bioelectrical impedance analysis(6 months post-recovery)
- medium-term immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots(6 months post-recovery)
- short-term cost-efficiency(up to 16 weeks)
- medium-term cost-efficiency(6 months post-recovery)
- mid-upper-arm circumference (MUAC) gain during treatment(weekly for up to 16 weeks)
- mortality rate(weekly for up to 16 weeks)
- changes to phase angle (PhA) as measured by bioelectrical impedance analysis(up to weekly for up to 16 weeks)
- changes to total body water (TBW) as measured by bioelectrical impedance analysis(up to weekly for up to 16 weeks)
- changes in immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots(up to weekly for up to 16 weeks)
- rates of acute illness, including diarrhea, vomiting, and fever during treatment(weekly for up to 16 weeks)
- medium-term rate of development of acute malnutrition(up to 6 months post-recovery)
- medium-term weight gain(6 months post-recovery)
- medium-term total body water (TBW) as measured by bioelectrical impedance analysis(6 months post-recovery)
- medium-term rates of relapse to MAM(up to 6 months post-recovery)
- medium-term rates of hospitalization(up to 6 months post-recovery)
研究者
Heather Stobaugh
Senior Research and Learning Specialist
Action Against Hunger USA
研究点 (4)
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