Slusher Tina M, Olusanya Bolajoko O, Vreman Hendrik J, Wong Ronald J, Brearley Ann M, Vaucher Yvonne E, Stevenson David K
Center for Global Health, Department of Pediatrics, University of Minnesota, Minneapolis, MN, USA.
Trials. 2013 Dec 28;14:446. doi: 10.1186/1745-6215-14-446.
Severe neonatal jaundice and its progression to kernicterus is a leading cause of death and disability among newborns in poorly-resourced countries, particularly in sub-Saharan Africa. The standard treatment for jaundice using conventional phototherapy (CPT) with electric artificial blue light sources is often hampered by the lack of (functional) CPT devices due either to financial constraints or erratic electrical power. In an attempt to make phototherapy (PT) more readily available for the treatment of pathologic jaundice in underserved tropical regions, we set out to test the hypothesis that filtered sunlight phototherapy (FS-PT), in which potentially harmful ultraviolet and infrared rays are appropriately screened, will be as efficacious as CPT.
METHODS/DESIGN: This prospective, non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin (TSB, defined as 3 mg/dl below the level recommended by the American Academy of Pediatrics for high-risk infants requiring PT) who will be randomly and equally assigned to receive FS-PT or CPT for a total of 616 days at an inner-city maternity hospital in Lagos, Nigeria. Two FS-PT canopies with pre-tested films will be used. One canopy with a film that transmits roughly 33% blue light (wavelength range: 400 to 520 nm) will be used during sunny periods of a day. Another canopy with a film that transmits about 79% blue light will be used during overcast periods of the day. The infants will be moved from one canopy to the other as needed during the day with the goal of keeping the blue light irradiance level above 8 μW/cm²/nm.
FS-PT will be as efficacious as CPT in reducing the rate of rise in bilirubin levels. Secondary outcome: The number of infants requiring exchange transfusion under FS-PT will not be more than those under CPT.
This novel study offers the prospect of an effective treatment for infants at risk of severe neonatal jaundice and avoidable exchange transfusion in poorly-resourced settings without access to (reliable) CPT in the tropics.
ClinicalTrials.gov Identifier: NCT01434810.
在资源匮乏的国家，尤其是撒哈拉以南非洲地区，严重的新生儿黄疸及其进展为核黄疸是新生儿死亡和残疾的主要原因。使用带人工蓝光光源的传统光疗（CPT）治疗黄疸的标准方法，常因资金限制或电力供应不稳定而缺乏（可用的）CPT设备而受阻。为了使光疗（PT）在服务不足的热带地区更易于用于治疗病理性黄疸，我们着手检验以下假设：经过滤的阳光光疗（FS-PT），即对潜在有害的紫外线和红外线进行适当过滤，其疗效将与CPT相当。
方法/设计：这项前瞻性、非盲随机对照非劣效性试验旨在招募总血清/血浆胆红素（TSB，定义为比美国儿科学会针对需要PT的高危婴儿推荐水平低3mg/dl）升高的婴儿，这些婴儿将被随机且等分为两组，在尼日利亚拉各斯的一家市中心妇产医院接受FS-PT或CPT治疗，为期共616天。将使用两个带有预先测试过薄膜的FS-PT遮阳篷。一个遮阳篷的薄膜可透射约33%的蓝光（波长范围：400至520nm），将在一天中的晴天使用。另一个遮阳篷的薄膜可透射约79%的蓝光，将在一天中的阴天使用。婴儿将在白天根据需要从一个遮阳篷转移到另一个遮阳篷，目标是使蓝光辐照度水平保持在8μW/cm²/nm以上。
FS-PT在降低胆红素水平上升速率方面将与CPT疗效相当。次要结局：接受FS-PT治疗的婴儿中需要换血的人数不会多于接受CPT治疗的婴儿。
这项新研究为资源匮乏且热带地区无法获得（可靠的）CPT的环境中，有严重新生儿黄疸风险的婴儿提供了一种有效的治疗方法，并有望避免不必要的换血。
ClinicalTrials.gov标识符：NCT01434810。
