Cycled Phototherapy: A Safer Effective Method to Control the Serum Bilirubin Of Extremely Premature Infants?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,700
- 试验地点
- 38
- 主要终点
- Number of participants survival to discharge
研究概览
简要总结
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (< 750 g BW or <27 weeks GA).
详细描述
Were they not delivered early, extremely premature infants would normally develop in darkness within the uterus for 3-4 more months longer before birth. Yet, the routine care of these infants has involved the use of uninterrupted (continuous) exposure to bright light during phototherapy (PT), a treatment method that neonatologists have assumed has no serious adverse effects on even the most immature of newborns.
Immaturity, thin translucent skin, and a multitude of other problems may make extremely premature infants highly vulnerable to the photo-oxidative injury, lipid peroxidation, DNA damage, reduced cerebral and mesenteric blood flow, or other serious potential hazards of uninterrupted exposure to PT that have now been identified. Such hazards were not recognized when continuous PT was widely incorporated into neonatal care, and the survival rate of extremely premature infants (<27 wks gestation or <750 g birth weight) was much lower than today.
PT rapidly photoisomerizes bilirubin in the subcutaneous tissues and vasculature, and six trials of cycled PT have demonstrated that use of cycled PT reduces the total hours of PT and results in minimal or no increase in peak TSB over that with continuous PT in term or moderately preterm infants. Recent findings from a pilot study (NCT01944696) support a PT regimen for this Cycled Phototherapy protocol.
Infants born at one of the Neonatal Research Network centers, ≤ 750 grams at birth and/or < 27 weeks gestation at birth by best OB estimate will be considered for this study.
Those who qualify will be randomized to either cycled PT or continuous PT. The cycled phototherapy begins with >15 min/h cycled PT regimen and increased to 30 min/h if the TSB is 8.0-9.9 and 60 min/h if the TSB is >10 mg/dL. Those randomized to continuous phototherapy will undergo continuous exposure,as that is commonly used in NRN centers.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Weeks 至 27 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants is inborn
- •Infant is ≤ 750 grams at birth and/or < 27 weeks gestation at birth by best OB estimate
- •Infant is 12-36 hours of age.
排除标准
- •Unable to enroll infant by 36 hours of age
- •Previous phototherapy
- •Known hemolytic disease
- •TSB reported as >6.0 mg/dL before 12 hours age
- •Major anomaly
- •Overt nonbacterial infection
- •Infant is likely to expire soon: Limiting or withdrawal of intensive care is being recommended to the parents, the parents are requesting withdrawal of care, or the pH is < 6.80 or persistent bradycardia with hypoxemia for >2h.
研究组 & 干预措施
Continuous Phototherapy
Continuous phototherapy
干预措施: Phototherapy lights (Device)
Cycled Phototherapy
Cycled phototherapy at timed intervals, dependent upon total serum bilirum (TSB) levels.
干预措施: Phototherapy lights (Device)
结局指标
主要结局
Number of participants survival to discharge
时间窗: Birth to hospital discharge, up to 120 days of life
Number of Participants discharged from hospital alive, after birth.
次要结局
- Number of hours of Phototherapy(Start until the end of intervention period (duration of 2 weeks))
- Number of Participants with Major neonatal morbidity(Birth to hospital discharge, up to 120 days of life)
- Number of irradiance hours(Start until the end of intervention period (duration of 2 weeks))
- Number of Participants with Ventricular enlargement of cystic white matter disease, as a component predischarge morbidity(Birth to hospital discharge, up to 120 days of life)
- Number of Participants with Late onset sepsis, as a component predischarge morbidity(Birth to hospital discharge, up to 120 days of life)
- Peak Concentration of Total Serum Bilirubin(Start until the end of intervention period (duration of 2 weeks))
- Number of Participants with Bronchopulmonary dysplasia (BPD), as a component predischarge morbidity(Birth to hospital discharge, up to 120 days of life)
- Number of Participants with Patent ductus arteriosus (PDA) treated with surgery or NSAIDS(Birth to hospital discharge, up to 120 days of life)
- Number of Participants with Neurodevelopmental Impairment(Birth to 26 months corrected age)
- Concentration of Total Serum Bilirubin(Start until the end of intervention period (duration of 2 weeks))
- Number of Participants with Severe ICH, as a component of the predischarge morbidity(Birth to hospital discharge, up to 120 days of life)
- Number of Participants with Necrotising enterocolitis (NEC) or spontaneous intestinal perforation, as a component predischarge morbidity(Birth to hospital discharge, up to 120 days of life)
- Number of Participants with Grade 3 (or greater) retinopathy of prematurity (ROP), as a component predischarge morbidity(Birth to hospital discharge, up to 120 days of life)
- Number of Participants with Neurodevelopmental Impairment or Death(Birth to 26 months corrected age)