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临床试验/NCT06653790
NCT06653790尚未招募不适用

EFFECT of PSYCHOSOCIAL STIMULATIONS on TREATMENT OUTCOME of SEVERE ACUTE MALNOURISHED CHILDREN

Universiti Putra Malaysia0 个研究点目标入组 800 人开始时间: 2024年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
800
主要终点
Developmental performance

研究概览

简要总结

A playroom and a playground are already part of the stabilization unit and are furnished with basic facilities for engaging the SAM children in play-based motor, language, and personal-social activities. The severely acute malnourished children in the intervention group will be sent to a development pediatrician who will do a developmental assessment of the child and stimulation. A sensory therapist, an occupational therapist, and a physiotherapist will also be available for sessions.

详细描述

The World Health Organisation (WHO) also suggests including psychological stimulation in the treatment of severe acute malnutrition. However, there is limited evidence that these interventions are beneficial for SAM children, especially when there are severe food shortages and a lack of a balanced diet.

There is limited available research in Pakistan examining the impact of psychosocial stimulation on severely malnourished children and a significant gap in its implementation. It is obvious that current implementation research is needed to understand how to improve brain development in children with SAM who require inpatient care in a practical and pragmatic approach.

The purpose of this study is to present data on the efficacy of these therapies, which may help shape future SAM treatment plans and policies. Mitigating the physical and mental dimensions of malnourishment can result in more enduring and significant consequences, ultimately enhancing the standard of living for millions of children around the globe.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Care Provider, Investigator)

盲法说明

The care provider and investigators will be blided

入排标准

年龄范围
6 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All children aged 6m to 59 months admitted to stabilization centre fulfilling criteria of severe acute malnutrition will be included in study.

排除标准

  • Children with chronic diseases like cystic fibrosis, cerebral palsy, celiac disease, chronic kidney disease, chronic liver failure, congenital heart disease, inborn error of metabolism, cleft lip and palate will be excluded from study.

结局指标

主要结局

Developmental performance

时间窗: 6- months from baseline

Developmental performance in terms of gross motor, fine motor, language and personal-social by using Denver II developmental screening test. The number of test items that a child has successfully performed (passed) is described as the performance score. A child is delayed if he fails to perform what 90% of children of that age can perform. Caution is raised if a child is not able to perform a task that 75% to 90% of children can perform.

次要结局

  • Child growth(6- months from baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arshed Muhammad

PhD

Universiti Putra Malaysia

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