A Randomized Trial of Aggressive or Conservative Phototherapy for Extremely Low Birth Weight Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,974
- 试验地点
- 34
- 主要终点
- Death or neurodevelopmental impairment (MDI <70; PDI <70; cerebral palsy; blindness; or severe hearing loss)
研究概览
简要总结
This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants. The primary hypothesis was that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age in infants treated by either aggressive or conservative threshold limits. 1,978 infants were enrolled.
详细描述
In NICHD Neonatal Research Network (NRN) centers in 2002, phototherapy was administered to 94 percent of the extremely low birth weight (ELBW) infants who survive more than 12 hours. Yet, it is unclear what level of bilirubin in the blood is harmful for these very tiny infants -- no data existed from large or recent clinical trials to define the risks, benefits, and appropriate indications for phototherapy in these infants. The largest and most recent trial was the NICHD Collaborative Phototherapy Trial which involved infants treated in 1974-1976 and included only 77 ELBW infants. Data from this study and others suggested that phototherapy could have important hazards as well as benefits for ELBW infants.
This NRN study used two different bilirubin levels as thresholds for timing of phototherapy in 1,978 extremely low birth weight infants, examining the primary hypothesis that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age between the aggressively and conservatively treated groups.
Enrolled infants were stratified by birth weight (501-750g and 751-1,000g) and randomized to receive phototherapy regimens based on either an aggressive threshold or a conservative threshold of total serum bilirubin.
In the Aggressive group:
- 501-750 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 5 mg/dl for day of life 1-14.
- 751-1,000 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 5 mg/dl for day of life 1-7 and 7 mg/dl for day of life 8-14.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Hours 至 36 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •501-1000 grams birth weight
- •12-36 hours postnatal age
排除标准
- •Terminal condition (pH <6.8 for >2 hours OR persistent bradycardia, heart rate <100 bpm, associated with hypoxia for >2 hours]
- •Prior use of phototherapy
- •Major congenital anomaly
- •Hydrops fetalis or severe hemolytic disease diagnosed in-utero
- •Overt congenital nonbacterial infection
- •Parental refusal or inability to provide consent
- •Attending physician refusal
- •Parents who are considered unlikely to return for follow-up evaluation
结局指标
主要结局
Death or neurodevelopmental impairment (MDI <70; PDI <70; cerebral palsy; blindness; or severe hearing loss)
时间窗: 0-22 months corrected age
次要结局
- Hearing assessments(120 days old or at discharge)
- Retinopathy of prematurity(36 weeks post conceptual age)
- Intraventricular hemorrhage (IVH) by grade(120 days old or at discharge)
- Periventricular leukomalacia(120 days old or at discharge)
- Necrotizing enterocolitis (NEC)(120 days old or at discharge)
- Ventilator settings and FiO2 at 36 weeks(36 weeks post conceptual age)
- Patent ductus arteriosus requiring drug or surgical treatment(36 weeks post conceptual age)
- Sepsis(120 days old or at discharge)
- Bronchopulmonary dysplasia (BPD)(36 weeks post conceptual age)