Yang Ge, Deng Li, Zhang Kun, Liu Hui-Juan, Fu Xin-Rui, Hu Yue, Yan Xiao-Dan, Zhou Xiao-Yun, Luo Wei, Wang Si-Yao, Ye Xiao-Tong, Zhang Tian-Lang, Li Fan, Huo Zhuan-Xia, Jiang Yan, Zeng Shan, Wu De-Hua, Yuan Yuan, Zhang Hua-Yan
Division of Neonatology and Center for Newborn Care, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, No. 9 Jinsui Road, Tianhe District, Guangzhou, 510623, Guangdong Province, People's Republic of China.
Clinical Research Center, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
World J Pediatr. 2025 Aug;21(8):792-799. doi: 10.1007/s12519-025-00954-y. Epub 2025 Aug 4.
Neonatal hyperbilirubinemia risk factors determination is challenging due to the lack of quantifiable indicators for bilirubin production, resulting in phototherapy decisions made without real-time information. End-tidal carbon monoxide (CO) corrected for ambient CO (ETCOc) may be helpful for identifying hemolysis, but evidence on the application of ETCOc as a risk factor for the development of neonatal hyperbilirubinemia is scarce. This study aimed to evaluate whether the use of ETCOc to adjust neonatal hyperbilirubinemia risk categories and thus phototherapy thresholds can reduce the rate of phototherapy within the first seven days of life.
This is a randomized clinical trial including near-term and term infants with a transcutaneous bilirubin 40th percentile within 72 hours after birth in a single center in Guangdong, China. Newborns were randomized to receive ETCOc-adjusted risk assessment or empirical assessment per local practice to establish phototherapy thresholds. The primary outcome was the rate of phototherapy within seven days of life. Secondary outcomes were postnatal hours at phototherapy, total serum bilirubin and ETCOc before phototherapy, severe hyperbilirubinemia and phototherapy duration.
A total of 2500 infants were enrolled and randomized. Phototherapy within seven days of life occurred in 237 infants (18.9%) in the intervention group and 281 infants (22.5%) in the control group [adjusted relative risk: 0.85; 95% confidence interval (CI): 0.73, 0.98]. The ETCOc before phototherapy was 0.28 parts per million higher (95% CI: 0.10, 0.46) in the intervention group. The rate of subsequent severe hyperbilirubinemia was not significantly different, and other secondary outcomes were comparable between the two groups.
For near-term and term infants at risk of neonatal hyperbilirubinemia, the use of ETCOc to adjust neonatal hyperbilirubinemia risk categories can decrease the rate of phototherapy at seven days of life. Integrating the ETCOc to adjust the phototherapy threshold is helpful in the management of severe hyperbilirubinemia.
由于缺乏胆红素生成的可量化指标，新生儿高胆红素血症风险因素的判定具有挑战性，这导致光疗决策缺乏实时信息。经环境一氧化碳（CO）校正的潮气末一氧化碳（ETCOc）可能有助于识别溶血，但关于将ETCOc作为新生儿高胆红素血症发生风险因素应用的证据较少。本研究旨在评估使用ETCOc调整新生儿高胆红素血症风险类别从而调整光疗阈值是否能降低出生后7天内的光疗率。
这是一项随机临床试验，纳入了中国广东某单一中心出生后72小时内经皮胆红素处于第40百分位数的近足月儿和足月儿。新生儿被随机分组，分别接受基于ETCOc调整的风险评估或按照当地常规进行经验性评估以确定光疗阈值。主要结局是出生后7天内的光疗率。次要结局包括光疗时的出生后小时数、光疗前的总血清胆红素和ETCOc、重度高胆红素血症以及光疗持续时间。
共纳入2500例婴儿并进行随机分组。干预组237例婴儿（18.9%）在出生后7天内接受了光疗，对照组281例婴儿（22.5%）接受了光疗[校正相对风险：0.85；95%置信区间（CI）：0.73，0.98]。干预组光疗前的ETCOc高0.28ppm（95%CI：0.10，0.46）。后续重度高胆红素血症的发生率无显著差异，两组间其他次要结局具有可比性。
对于有新生儿高胆红素血症风险的近足月儿和足月儿，使用ETCOc调整新生儿高胆红素血症风险类别可降低出生后7天的光疗率。整合ETCOc以调整光疗阈值有助于重度高胆红素血症的管理。
