Effect of Education on Prevalence of Kernicterus in Five Regions in Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,765
- 主要终点
- Acute bilirubin encephalopathy
研究概览
简要总结
This study examines (a) whether introduction of public, health provider, and maternal education about risks of jaundice will decrease the occurrence of ABE compared with baseline prevalence (before-after design) or (b) whether antenatal or postpartum instruction to mothers will decrease the incidence of ABE compared with those who did not received instruction (concurrent opportunistic controls in phase 2).
详细描述
This 2 phase study first determines the prevalence of acute bilirubin encephalopathy (ABE) among newborns admitted for treatment of jaundice at 5 regional centers in Nigeria and identifies social/behavioral/medical factors associated with ABE. Information gained in phase 1 identified high risk sub-populations and guided selection of instructional materials for phase 2. Core data sheets submitted monthly by participating centers included clinical data, demographic information, number of antenatal clinic visits, birth place (hospital, clinic, home) and attendant, distance from care centers and reasons for delay, if any, in seeking care. Receipt of jaundice instruction by mothers is self-reported. Statistical analysis includes Chi square and logistic regression analysis of risk factors. Sample size: 1,000 subjects in each phase are required to demonstrate a 20% decrease in disease prevalence (baseline ABE incidence anticipated to be 15% of jaundiced babies) at 95% confidence level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Minutes 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infant receiving treatment for neonatal jaundice
排除标准
- •Non-viable premature infants
- •Severe congenital defects.
- •Postnatal age greater than 21 days
结局指标
主要结局
Acute bilirubin encephalopathy
时间窗: at time of admission or discharge (1-21 days of life)
Clinical signs of bilirubin toxicity described by unique neurological features in the presence of hyperbilirubinemia: reported as yes, no, or suspect (mild signs)
次要结局
- Death from acute bilirubin encephalopathy or combined ABE/sepsis(1-21 days of life)
研究者
Richard Patridge Wennberg
Principal Investigator
Bilimetrix s.r.l.