Community Case Management of Chest Indrawing Pneumonia With Oral Amoxicillin in Children Aged 2-59 Months Old by Community Oriented Resources Persons (CORPs) in Niger State, Nigeria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Number of participants with clinical treatment failure
研究概览
简要总结
This one-arm safety intervention study is aimed at increasing access to treatment of pneumonia by training CHWs, locally referred to as Community Oriented Resource Persons (CORPs), to manage chest indrawing pneumonia using oral amoxicillin, conducting follow-ups and recording their findings in case report forms. CORPs will also be involved in improving care seeking for pneumonia in children by training them to conduct health education sessions for men and women in their respective communities.
The primary objective is to assess if CORPs can safely and appropriately manage chest indrawing pneumonia in 2-59 month old children, and refer children with danger signs. The primary outcomes will be the proportion of children under five with chest indrawing pneumonia who were managed appropriately by CORPs and the clinical treatment failure of chest indrawing pneumonia. Secondary outcomes will include proportion of children with chest indrawing followed up by CORPs on day 3 and caregiver adherence to treatment for CI, and clinical relapse of pneumonia between day 7 to 14 among children whose signs of pneumonia disappeared by day 6. Approximately 308 children 2-59 months of age with chest indrawing pneumonia would be needed for this safety intervention study.
详细描述
OBJECTIVES AND RATIONALE This one-arm safety intervention study aims to establish whether CHWs in Nigeria can safely manage chest indrawing pneumonia in 2-59 month old children. The primary outcomes will be the proportion of children under five with chest indrawing pneumonia who were managed appropriately by Community Oriented Resources Persons (CORPs) and the clinical treatment failure by day 6. Secondary outcomes will include proportion of children with chest indrawing followed up by CORPs on day 3, clinical relapse of pneumonia between day 7 to 14 and acceptability and satisfaction with outpatient management of chest indrawing pneumonia. A total of 308 children 2-59 months of age with chest indrawing pneumonia will be needed for this safety intervention study.
EXPERIMENTAL DESIGN AND METHODOLOGY Introduction Malaria Consortium (MC) intends to implement the WHO study, funded under the Rapid Access Expansion 2015 programme (RAcE 2015), on community case management of chest indrawing pneumonia with oral amoxicillin in children aged 2-59 months old by CORPs and submits this proposal for Niger state, Nigeria.
Study area Proposed study population Niger State, located in Nigeria's North Central Zone, is geographically the largest of the country's states, covering 76,263 km2. The state has a projected population of almost 5 million. Children under five years make up 21% of the population, and pregnant women constitute 5%. The population is made up of Muslims, Christians with a small minority practising traditional beliefs. The majority of the population are spread across rural areas, with 30% of the population living in urban areas. Under WHO RAcE 2015 project MC is working with the Federal Ministry of Health (FMoH) to strengthen the iCCM programme in six (LGAs) in the three zones in Niger state: Paikoro; Rafi; Mariga; Rijau; Lapai; and Edati. The total population of the six LGAs is 1,245,939 of whom approximately 249,200 are children aged 2-59 months. Pneumonia remains the leading cause of under 5 child mortality in Nigeria which, together with India, contributes the highest absolute numbers of pneumonia deaths in the world, with 804,429 deaths in children under five years in 2013 (2). The expected incidence of clinical pneumonia in this area in Nigeria is 0.28/child/year with an estimated 12% progressing to severe disease.
Objectives and outcomes This one-arm safety intervention study aims to establish whether CHWs in Nigeria can safely and appropriately manage chest indrawing pneumonia in 2-59 month old children.
Primary outcomes will be the proportion of children under five classified with chest indrawing pneumonia who were managed appropriately by Community Oriented Resources Persons (CORPs) and the clinical treatment failure of chest indrawing pneumonia by day 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chest indrawing pneumonia
排除标准
- •Convulsions
- •Cough for 14 days or more
- •Blood in stool
- •Fever for last 7 days or more
- •Diarrhoea for 14 days or more
- •Not able to drink or feed anything
- •Unusually sleepy or unconscious
- •Vomits everything
- •Swelling of both feet
- •Red on MUAC strap (severe acute malnutrition)
研究组 & 干预措施
Oral amoxicillin for CI pneumonia
Community management of chest indrawing pneumonia using oral amoxicillin by CHWs
干预措施: Oral amoxicillin for CI pneumonia (Drug)
结局指标
主要结局
Number of participants with clinical treatment failure
时间窗: By day 3 to 6
The proportion of children enrolled with any of the following signs by day 6: * Appearance of a danger sign (unable to drink or breastfeed, convulsions, vomiting after ingestion of food or drink, and abnormally sleepy or difficult to wake) * Hypoxemia (Oxygen saturation ≤90%) * Temperature ≥37.5°C and chest indrawing on day 3 * Temperature ≥37.5°C or chest indrawing alone on day 6 * Change of antibiotic * Death
Number of CHWs appropriately managing chest indrawing pneumonia
时间窗: At day of enrolment
Proportion of children with RA verified chest indrawing pneumonia with no referral sign (unable to drink or breastfeed, convulsions, vomiting after ingestion of food or drink, and abnormally sleepy or difficult to wake, malnutrition) who received the correct age-specific amoxicillin dose for 5 days Proportion of children with RA verified chest indrawing pneumonia with suspected referral sign (unable to drink or breastfeed, convulsions, vomiting after ingestion of food or drink, and abnormally sleepy or difficult to wake, malnutrition) who were given pre-referral amoxicillin treatment and were referred to a health facility.
次要结局
- Number of children with chest indrawing pneumonia followed up by CHWs(By day 3)
- Number of children with clinical relapse of pneumonia(Between day 7 and 15)
- Number of caregivers who find outpatient management of chest indrawing pneumonia acceptable for their child(15 days after enrolment)