Efficacy of Community-based Follow-up, Food Supplementation and Psychosocial Stimulation in the Home-management of Young Severely Malnourished Bangladeshi Children: a Randomized Intervention Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 507
- 主要终点
- Rate of follow up
研究概览
简要总结
Improved methods of community/home management and follow-up of severely undernourished children need to be developed in low-income countries like Bangladesh. The proposed study will be conducted at ICDDR,B Hospital and in different urban primary health care centres within Dhaka city. The efficacy of four different interventions will be evaluated/compared with control with respect to the rate of completion of clinical follow-up and growth, morbidity, and changes in psychomotor development in 500 children aged 6-24 months presenting to ICDDR,B with initial weight-for-age (WA) <-3 Z score. The interventions are:
- Usual follow-up (fortnightly for 1st 3 months) service at the hospital nutrition follow-up unit (HNFU) including growth monitoring and promotion + health education + micronutrient supplementation and treatment of intercurrent illness (current standard practice; control group).
- All management like control group, but follow up at community-based nutrition follow-up unit (CNFU) (fortnightly for 1st 3 months) (intervention A).
- All management like intervention A at CNFU + supplementary food (SF) for the first 3 months (intervention B).
- All management like intervention A at CNFU + psychosocial stimulation (PS) for the first 3 months (intervention C).
- All management like intervention A at CNFU + SF + PS for the first 3 months (intervention D).
After the initial three months intervention period, children in all groups will be followed on fortnightly basis for next three months in their respective follow up unit.
Follow-up rate, nutritional status, mental and psychomotor development, behavior, morbidities (including intestinal permeability in a sub-sample) of the children, and child rearing practices, depression and self esteem of mothers will be assessed in different groups.
By ascertaining the most cost-effective/best management package, and by extending the package to other systems in the country, it will be possible to rehabilitate a greater number of severely malnourished children in their communities.
详细描述
Study Design. A prospective, randomized, intervention trial.
Study site. The study will be conducted in Dhaka, Bangladesh. The children will be recruited on discharge from the Dhaka Hospital of ICDDR,B after treatment of their acute illnesses, and the follow up visits will be conducted at HNFU or CMFU (will be established) at four PHC or community clinics of Demra, Gulshan, Sabujbagh and Mirpur thanas of Dhaka city. The rationale for choosing these four thanas is that higher proportions of children with severe malnutrition come from these four thanas or nearby areas (unpublished data; Ahmed et al., ICDDR,B, 2001).
Initial hospital-based treatment protocol. At ICDDRB, severely malnourished children are treated in either the general ward or the special care unit of the Dhaka Hospital, according to a standardized protocol [50], which is similar to that recommended by WHO [5]. Implementation of this protocol has resulted in a 47% reduction in the case-fatality rate (CFR) among severely malnourished children [51] and according to recent observation there was further reduction of the case-fatality rate to 68 % (the current CFR is 5.4%).
Criteria for enrollment. Once the children complete the initial phase of management of any acute problems associated with severe malnutrition, they will be considered for recruitment, according to the following inclusion criteria:
- Age 6 - 24 months
- Either sex
- Severely malnourished [weight for age (WA) < -3 Z score]
- Resolution of acute illnesses
- Not planning to leave the current residence within next six months (for the purpose of follow-up)
- Informed consent granted from the guardian.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 - 24 months
- •Severely malnourished [weight for age (WA) < -3 Z score]
- •Resolution of acute illnesses
- •Not planning to leave the current residence within next six months (for the purpose of follow-up)
- •Informed consent granted from the guardian.
排除标准
- •Persistent anorexia, fever, severe wasting (WH < -3 Z score) or edema
- •Clinically apparent congenital/acquired disorders that may affect growth
- •Other acute or chronic diseases requiring hospitalization and/or affecting growth
- •Lack of fixed address (to avoid difficulties in tracing for follow up examinations)
- •Caregiver's condition: children accompanied by caregivers who are not able to give any time for child care or unable to give stimulation due to any condition e.g. old age, disease, physical or mental handicap.
结局指标
主要结局
Rate of follow up
时间窗: Up to 3 months of intervention
Rate of weight gain
时间窗: after 3 months of intervention
次要结局
- Changes in urinary Lactulose: Mannitol (ratio)(By the end of 3 months)
- Changes in development index(Changes over 6 months)