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临床试验/NCT04045249
NCT04045249已完成不适用

Comparison Between Different Feeding Protocols and Existing Protocol for the Treatment of Acute Malnutrition (A Cluster Randomized Controlled Clinical Trial)

Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年12月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Duration of recovery from SAM

研究概览

简要总结

Though malnutrition is prevalent worldwide but its situation is alarming in low- and middle-income countries. Pakistan has also been facing an alarming situation of prevailing severe malnutrition. Malnutrition in its any form costs a huge intolerable burden not only on national health care system, but also on social and economic fabric of the nation. The current management of severe malnutrition is based on World Health Organization (WHO) guidelines and protocols which has been evolved from expert opinions and observational studies. The principles of these protocols have emerged from emergency settings and converting these protocols for developing countries where severe malnutrition, a routine burden is a critical challenge. In the absence of standard protocols for the treatment of uncomplicated severe malnutrition in non-emergency settings it is important to test and optimize different approaches to treat severely acute malnutrition (SAM). It is hypothesized that by optimizing, adapting and implementing time oriented and resource intensive approaches, a huge burden of high cost of RUTF may be reduced. While RUTF may be utilized to treat SAM children in emergency settings, it is not a substitute of local household foods. Therefore, a pilot study has been conducted to compare the various treatment protocols for malnourished children. We specifically hypothesized that a reduced dose of RUTF for reduced duration, combined with age-appropriate food intake from locally available resources can treat uncomplicated SAM children cost effectively as compared to standard national Community Management of Acute Malnutrition (CMAM) protocol currently implemented in Punjab, Pakistan.

详细描述

Malnutrition signifies to inadequacies, immoderations or imbalances in an individual's consumption of nutrients or energy. The word malnutrition covers both under and over-nutrition. Undernutrition manifest in two different ways acute and chronic malnutrition. The acute malnutrition includes wasting while chronic malnutrition includes stunting. The situation of malnutrition has been perplexed in Pakistan in recent years and according to National Nutrition Survey (2018) rates of wasting are alarmingly high. Also, Pakistan ranks at 2nd position for infant and child mortality. The standard treatment of uncomplicated SAM in Pakistan often utilizes prolonged use of therapeutic food (RUTF), and after discharge results in high rates of relapse(official data from department of Health doesn't support this statement, according to them there is low rate of relapse). The present pilot study was conducted with the objective to find cost effective treatment protocols for treatment of uncomplicated SAM children. The study was conducted at The Children's Hospital and Institute of Child Health, Lahore in Out Patient Therapeutic Program (OTP) of Preventive Pediatrics Department. The children diagnosed with SAM aged 6-59 months without any specific gender preference were recruited. Weight, height and MUAC were measured at the time of enrolment in the study and Weight for Height (WHZ), Weight for Age (WAZ), Height for Age (HAZ) standard deviation (SD) Z scores and weight velocity was calculated for baseline. For current pilot study SAM children were grouped into 3 clusters. First, 30 children were grouped in 1st cluster, next 30 in 2nd cluster and further next 30 in 3rd cluster. Children in 1st cluster were treated as per standard CMAM protocols. Children in this cluster were provided RUTF as per admission weight of child until they attain 11.5cm MUAC or >-3SD WHZ. The children in the 2nd group (1st intervention group) were initially provided RUTF until they attain MUAC 11cm. After this, children were provided 50% of their required daily calories intake by RUTF and 50% of the calories were provided by the home-based food. The children in the 3rd group (2nd intervention group) were initially provided RUTF until they attain MUAC 11 cm. After this, children were provided their 100% caloric requirement from home-based food along with micronutrients sachets (MMS). The discharge criteria for control group was according to the existing CMAM guidelines that is MUAC > 11.5 cm. The discharge criteria for 2nd & 3rd group was MUAC > 12.5 cm and WHZ > -2SD score. Follow-up home visits of all children were done according to a predefined protocol. During follow-up the control and intervention groups underwent weekly anthropometric measurements. Follow up of the study participants of each group was continued for one month. Growth rate, recovery rate, mortality rate, relapse frequency and duration of recovery were calculated for each group.

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
None

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

  • Children 6-59 months with MUAC <11.5cm and Weight for Height Z score < -3SD
  • Having good appetite, alert and clinically well

排除标准

  • WHZ score - 4 SD
  • MUAC < 8 cm
  • Secondary malnutrition diagnosed by a gastroenterologist and dietitian
  • Family History
  • Birth Anomolies
  • Any hidden/ asymptomatic health conditions
  • Any patient coming from out of city (Lahore)
  • High fever (>104 F)
  • Severe pallor
  • Severe dehydration
  • Lower respiratory tract infection
  • Bipedal edema
  • Visible severe wasting

研究组 & 干预措施

1st Group

No Intervention

Children were treated as per standard CMAM protocols; provided RUTF until MUAC reaches 11.5 cm

2nd Group (1st Intervention group)

Experimental

Children were initially provided RUTF until MUAC reach 11 cm then 50 % calories were provided from RUTF and 50% calories from home based food

干预措施: Home based food (Dietary Supplement)

3rd Group (2nd Intervention)

Experimental

Children were initially provided RUTF until MUAC reach 11 cm then 100 % calories provided from home based food

干预措施: Home based food (Dietary Supplement)

结局指标

主要结局

Duration of recovery from SAM

时间窗: 3 months

Time required each child to reach MUAC \> 11.5

Rate of relapse

时间窗: 3 months

Number of children relapsed during the trial

Rate of mortality

时间窗: 3 months

Number of children dying during trial

Growth velocity

时间窗: 3 months

Weight in Kg

次要结局

  • Rate of recovery from Moderate Acute Malnutrition in 1st group(3 months)
  • Number of children having diarrhoea and acute respiratory infection during trial(3 months)
  • Number of children not coming for follow up visits due to any reason(3 months)

研究者

发起方
Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Zahra Khan

Principal Investigator

Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab

研究点 (2)

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