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临床试验/NCT06709001
NCT06709001已完成不适用

CROSS: Colombia's Potential Realized: an Observational Study for Stunting

Abbott Nutrition1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2024年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
1
主要终点
Anthropometrics - Height/Length

研究概览

简要总结

This is a prospective, observational study for assessing malnutrition risk and its characteristics among children aged 1 to 5 living in under-resourced communities in Colombia. There is also a qualitative component that seeks to gain caregiver, community health worker (CHW), public health professional (PHP), and non-for-profit organization (NGO) insights related to malnutrition risk.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 1-5 years
  • Children's legal guardian agrees to participate in the study
  • Full term pregnancy
  • Residence in study area attending Children International (NGO) centers
  • Quantitative

排除标准

  • Children who have current medical conditions requiring hospitalization: gastrointestinal tract infections or inflammatory bowel disease; active tuberculosis; acute hepatitis B or C; human immunodeficiency virus OR malignancy; cystic fibrosis; immunodeficiency syndromes, congenital abnormalities of the respiratory tract, such as lung and respiratory cilia; an unsuspected foreign body in the respiratory tract; asthma; and known metabolic disorders, renal impairment, or rheumatic diseases and diabetes,
  • Congenital condition
  • Children with disabilities such as cerebral palsy, autism spectrum disorder, neurodegenerative disorders
  • Children with chronic or acute infections e.g. HIV, malaria
  • Children who are taking medications or other agents that could potentially affect body weight, including diuretics, appetite stimulants, steroids, and growth hormones.
  • Children already enrolled in a nutrition program/intervention that includes a supplement
  • Qualitative Inclusion Criteria:
  • NGO staff taking part in nutrition screenings
  • Caregivers taking part in nutrition screenings as part of this study
  • Community health workers (CHW) working with pediatric malnutrition risk
  • Public health professionals (PHP) working with pediatric malnutrition risk
  • Agrees to participate in focus group/survey
  • Qualitative Exclusion Criteria:
  • Not involved in the implementation of the study
  • Not involved in working with pediatric malnutrition risk
  • Declines participation in focus group/survey

结局指标

主要结局

Anthropometrics - Height/Length

时间窗: Baseline, 3 Months and 6 Months

Measured in cm

Anthropometrics - Mid-Upper Arm Circumference (MUAC)

时间窗: Baseline, 3 Months and 6 Months

Measured in mm

次要结局

  • Anthropometrics - Weight(Baseline, 3 Months and 6 Months)
  • Anthropometrics - Head Circumference(Baseline, 3 Months and 6 Months)
  • Nutrient Intake(Baseline and 6 Months)
  • Pediatric Quality of Life Inventory(Baseline and 6 Months)
  • World Health Organization Quality of Life Brief Version(Baseline and 6 Months)
  • Healthcare Resource Utilization(Baseline and 6 Months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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