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临床试验/NCT02669654
NCT02669654Unknown4 期

Effectiveness Trial of Day-care Versus Usual Care Management of Severe Pneumonia With or Without Malnutrition in Children Using the Existing Health System of Bangladesh

International Centre for Diarrhoeal Disease Research, Bangladesh4 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
4 期
入组人数
4,000
试验地点
4
主要终点
Clinical treatment failure by day 6 from severe pneumonia in the Day care clinics compare to the patients who will get treatment from Hospitals

研究概览

简要总结

Background: At present pneumonia and malnutrition have become the leading causes of mortality among <5-year-old children in developing countries. World Health Organization standard management of severe pneumonia and severe malnutrition requires hospitalization for supportive care. As many developing countries including Bangladesh do not have enough pediatric hospital beds to accommodate the demand for admission of all children with severe pneumonia and malnutrition, Investigators developed alternative treatment option such as "Day Care Approach", for those children who cannot be hospitalized, but are too sick to be managed in the community. After successful Day Care Approach of management of efficacy trials with severe childhood pneumonia and severe malnutrition, the next step is to conduct an effectiveness trial under "real life" condition, i.e. within the Health Systems of Bangladesh.

Burden: Pneumonia is the leading cause of mortality in developing countries, being responsible for 1,368,000 (18%) of annual 7.6 million deaths, 95% occurring in developing countries. Similarly, malnutrition is a major health problem with an estimated 1.7 & 3.6 million children dying annually because of Severe Acute Malnutrition & Moderate Acute Malnutrition, respectively.

Objectives: To assess & implement the Day Care Approach of management of severe childhood pneumonia with or without Moderate Acute Malnutrition and/or severe underweight into existing Health Systems of Bangladesh as a safe & cost effective alternative to Existing Treatment.

Methods: A cluster randomized controlled trial will be conducted in Bangladesh by involving 16 clusters (Wards) in Dhaka & 16 clusters (Unions) in rural areas that will be randomly assigned to intervention & control arm. Children with severe pneumonia will be enrolled in (i) Tikatuli, (ii) Circular Road, (iii) Dhamrai Upazilla of Dhaka, (iv) Karimganj Upazillas to one of two management schemes: (i) Existing Treatment in control clusters or (ii) Day care Approach in intervention clusters by involving Comprehensive Reproductive Health Centres in urban and Health and Family Welfare Centres in rural areas.

Outcome variables:

  • Primary: clinical treatment failure by day 6
  • Secondary:

(i) Treatment failure between day 7-14 in children who are well on day 6 (ii) Cost effectiveness (iii) Referrals to hospitals (iv) Deaths

详细描述

Specific Objectives:

  1. To assess whether or not the Day care Approach for the management of severe childhood pneumonia with or without moderate acute malnutrition and/or severe underweight incorporated into the existing urban and rural Health Systems of Bangladesh is safe and effective.
  2. To implement the Day care Approach for the management of severe childhood pneumonia with or without moderate acute malnutrition and/or underweight within the Health Systems of Bangladesh as a cost effective alternative to the Existing Treatment of care for both the Health Systems and the families.
  3. To examine and compare the cost effectiveness of the Day care Approach versus Existing Treatment of care for the management of severe childhood pneumonia with or without moderate acute malnutrition and/or severe underweight.
  4. To identify and assess potential barriers and challenges during the whole implementation process.

Background of the Project including Preliminary Observations:

At present and depending on clinical presentation, pneumonia is classified as severe pneumonia, pneumonia, or no pneumonia, according to the recent guidelines by the World Health Organization in 2013. Since pneumonia is the leading cause of death in <5-year-old children, interventions to promote the prevention and treatment of pneumonia are an essential part of child survival efforts to achieve Millennium Development Goal 4. World Health Organization standard management of severe pneumonia requires hospitalization for supportive treatment including oxygen therapy for hypoxaemia, airway suctioning, fluid and nutritional management, antibiotics, and careful monitoring.

Most, if not all, developing countries including Bangladesh do not have enough hospitals, or pediatric hospital beds to accommodate the demand for admission of all children with severe pneumonia with or without malnutrition and other co-morbidity. In addition, mothers of ill children have other childcare and household responsibilities that constrain their ability to attend the child during hospitalization, which is often mandatory. Furthermore, transportation, cost, long distance from the hospital, lack of adequate child-care at home, or cultural perceptions represent additional huge limitations to hospitalization. Hospitalization also may not be feasible due to inability of parents to stay in hospital for the entire duration of illness. The sum total of all these common potential constraints lead to failure of hospitalization of children with severe pneumonia and severe malnutrition with or without additional co-morbidity. This inadequate availability and use of hospital beds leading to failure of hospitalization of children with severe pneumonia and/or malnutrition assuredly results in excess and unwanted deaths of children, who, with proper care, would otherwise survive. Although Investigators do not have direct evidence (no data available) that the bottleneck to pneumonia deaths in Bangladesh is lack of hospital beds mainly. But Investigators know from experience that many children with severe pneumonia requiring hospitalization are not hospitalized due to the lack of free pediatric beds, as observed during the observational day care studies.

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
2 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 2 to 59 months of age
  • Both male and female
  • Severe pneumonia with at least one of the following signs:
  • Central cyanosis
  • Hypoxaemia (Oxygen saturation < 90% on pulse oximetry)
  • Severe respiratory distress
  • Very severe chest indrawing
  • Signs of pneumonia with a general danger sign
  • Inability to breastfeed or drink
  • Reduced level of consciousness
  • Unconsciousness
  • Convulsions
  • Severe pneumonia with associated illnesses such as the following:
  • Moderate Acute Malnutrition
  • Severe under-weight [Weight-for-Age Z-score <-3]
  • Diarrhea with no or some dehydration
  • Living in the study area (in one of the above four primary study sites)
  • Informed consent given by parents/legal guardian

排除标准

  • Pneumonia
  • No pneumonia
  • Hospital-acquired/nosocomial pneumonia
  • Bronchiolitis
  • Severe Acute Malnutrition
  • Associated other severe diseases of childhood such as:
  • diarrhea with severe dehydration
  • Shock/severe sepsis
  • Meningitis/encephalitis
  • Bronchial asthma
  • Congenital Heart Disease
  • Participated in this study once and other study in the past 2 weeks
  • Received parenteral antibiotics for the current illness
  • Parents or legal guardians refusal to participate

结局指标

主要结局

Clinical treatment failure by day 6 from severe pneumonia in the Day care clinics compare to the patients who will get treatment from Hospitals

时间窗: 6 days

Patients will not recover within day 6 from severe pneumonia in the Day care clinics

次要结局

  • Treatment failure between day 7-14 in children who are well on day 6 from severe pneumonia in the Day care clinics compare to the patients who will get treatment from Hospitals(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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