Using Community Health Workers and In-home LED Phototherapy to Dramatically Reduce Brain Damage From Neonatal Jaundice in Low to Middle Income Countries: A Feasibility Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Breastfeeding rates within 1 hour of age
研究概览
简要总结
The main purpose of the study is to deliver community health worker based prevention, early screening and management of neonatal Jaundice using battery powered LED phototherapy device at the household level.
详细描述
Bangladesh like other low and middle-income countries has a high burden of hyperbilirubinemia induced neonatal morbidity and mortality. Approximately 60%-80% of newborns develop neonatal jaundice and 18% of infants are at risk for adverse outcomes from neonatal jaundice. Severe neonatal jaundice can put neonates at risk for long term neuro-developmental impairments and death. Delay in diagnosis and treatment of severe neonatal jaundice can result in brain damage to the newborn that is preventable with timely treatment.
Approximately 14 million infants per year in low to middle-income countries (LMIC) are at risk from neonatal jaundice progressing to extreme hyperbilirubinemia and brain damage. Nearly 80% of the 481,000 cases of extreme hyperbilirubinemia are in LMIC because infants are identified too late or health facility treatment is inaccessible or inadequate.
New, low-cost, easy to use screening and phototherapy treatment technologies enable our proposed redesign of care delivery in LMIC to save infant's brains. The investigators plan to shift care from specialists and hospitals to community health workers (CHW) and homes. Investigators will integrate CHW-led prevention during pregnancy, with timely household screening and treatment. Investigators will reach infants before brain damage occurs and treat infants who would not otherwise be treated.
LMIC including Bangladesh have had difficulty addressing neonatal jaundice because of the expense and logistics of providing timely prevention, screening and treatment to families. This study aim to test 3 hypothesis:
H1: Prenatal modules for pregnant mothers will increase breastfeeding rates at 1 hour of life and at 3 months of age.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The mothers are at late 2nd or early 3rd trimester of their pregnancy and agreed to enroll as study participants
- •They are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still not be a candidate for enrollment)
排除标准
- •Pregnant mother with confirmed multiple pregnancy.
- •Pregnant mother with medically identified psychological disorder.
- •Any known maternal danger sign.
结局指标
主要结局
Breastfeeding rates within 1 hour of age
时间窗: 6-8 months after the intervention
Mother reported breastfeeding rates within 1 hour of age will be measured following structured survey
Breastfeeding rates upto 3 months of age
时间窗: 6-8 months after the intervention
Mother reported breastfeeding rates after 3 months of age will be measured following structured survey
Number of newborns screened for neonatal jaundice
时间窗: 6-8 months after the intervention
Number of newborns screened for neonatal jaundice either in home or any government or non-government health facilities within 7 days of birth through a structured survey reported by mother.
Community health workers (CHW's) skill in assessing sick newborns
时间窗: During 6-8 months of the intervention
CHW's skill will be measured through a structured observation following a check list and subjective and objective assessment by registered physician
Number of newborns having at least one postnatal check-up within 48 hours.
时间窗: 6-8 months after the intervention
This measurement will be taken within 2 months of child birth through a structured survey, reported by mother.
Number of newborns that received indicated treatment for neonatal jaundice
时间窗: 6-8 months after the intervention
Number of children receiving indicated treatment for neonatal jaundice either in home or health facilities will be measured by a mother reported structured survey after 2 months of child birth
次要结局
未报告次要终点