Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Rebound hyperbilirubinemia
研究概览
简要总结
We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of newborn.
Objectives: The investigators aimed to compare the safety of implementing low-threshold, compared to high- threshold, of TSB for phototherapy interruption in term and late preterm neonates with hemolytic disease of newborn.
详细描述
Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate 2004 AAP phototherapy threshold, whereas neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP threshold.
Phototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol/L below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol/L of the threshold for exchange transfusion and not responding to initial intensified phototherapy.Infants with a TSB concentration above the thresholds for exchange should have immediate intensified 360◦ LED phototherapy, and preparation for exchange transfusion will be started.Infants showed clinical signs of acute bilirubin encephalopathy will have an immediate exchange transfusion.
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
- None
入排标准
- 年龄范围
- 1 Hour 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term and late-preterm neonates more than or equal 35 weeks gestation with hemolytic disease of newborn will be included. Enrolled infants should have evidence of hemolysis as defined by any of the following criteria:
- •positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or
- •HGB decline by 2g/dl within 24hour.
排除标准
- •Major congenital abnormalities,
- •Surgical problems,
- •Direct hyperbilirubinemia
结局指标
主要结局
Rebound hyperbilirubinemia
时间窗: 28 days
Number of participants of whome concentration of total serum bilirubin returned to or beyond the AAP phototherapy threshold within 72 hours of phototherapy discontinuation of a neonate's first round of phototherapy treatment.
次要结局
- Length of hospital stay(28 days)
- Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage(28 days)
- Rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage(28 days)
- Duration of phototherapy(28 days)
- Adverse effects related to phototherapy(28 days)
- Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage(28 days)
- Total Cost of NICU Care(90 days)
研究者
Fatema Sulaiman Alhazmi
Cilinical fellow, Madinah Maternity and Children's Hospital, NICU
Ministry of Health, Saudi Arabia