Luca Bedetti, Licia Lugli, Isotta Guidotti, Maria Federica Roversi, Elisa Della Casa Muttini, Marisa Pugliese, Natascia Bertoncelli, Eugenio Spaggiari, Alessandra Todeschini, Gina Ancora, Sara Grandi, Giancarlo Gargano, Claudio Gallo, Mario Motta, Piero Catenazzi, Luigi Tommaso Corvaglia, Vittoria Paoletti, Agostina Solinas, Elisa Ballardini, Serafina Perrone, Sabrina Moretti, Marcello Stella, Alberto Berardi, Fabrizio Ferrari
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It also aimed to identify predictors of outcomes and evaluate TH practices across centres.</p><p><strong>Methods: </strong>A prospective, area-based observational study was conducted in eight Italian NICUs (2016-2021), including neonates treated with TH for any grade of HIE. A 2-year neurodevelopmental follow-up was performed. Severe functional disability (SFD) was defined as cerebral palsy (Gross Motor Function Classification Level > 2), cognitive score < 2 SD, bilateral blindness/deafness, or epilepsy. Demographic, clinical and MRI data were analysed.</p><p><strong>Results: </strong>Among 283 cooled infants, 11 (3.8%) died and 272 (96.2%) survived. HIE severity was mild (14.0%), moderate (76.1%) and severe (9.9%). Follow-up data were available for 232 (85.3%) survivors, with SFD diagnosed in 27 (11.6%). No infants with mild HIE developed SFD. Severe MRI anomalies were found in 51.9% of SFD cases, while 90.7% of non-SFD children had normal findings. cEEG/aEEG-confirmed seizures (OR = 12.9, CI 3.5-65.0) and severe MRI anomalies (OR = 0.24, CI 0.13-0.44) were strong SFD predictors (AUC = 0.95).</p><p><strong>Conclusion: </strong>Mortality and SFD rates were lower than in RCTs. Seizures and severe MRI anomalies predicted poor outcomes. 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引用次数: 0
摘要
目的：本研究评估了在随机对照试验（RCTs）之外接受治疗性低温（TH）治疗的新生儿缺氧缺血性脑病（HIE）的神经发育结局。它还旨在确定结果的预测因素并评估各中心的TH做法。方法：对意大利8个新生儿重症监护病房（2016-2021）进行前瞻性、区域观察性研究，包括接受TH治疗的任何级别HIE新生儿。进行了2年的神经发育随访。重度功能障碍（SFD）定义为脑瘫（大运动功能分类水平>2），认知评分结果：283例患儿死亡11例（3.8%），存活272例（96.2%）。HIE严重程度为轻度（14.0%）、中度（76.1%）和重度（9.9%）。随访数据为232例（85.3%）幸存者，27例（11.6%）被诊断为SFD。轻度HIE患儿未发生SFD。51.9%的SFD患儿MRI表现严重异常，而90.7%的非SFD患儿MRI表现正常。cEEG/ aeeg证实的癫痫发作（OR = 12.9, CI 3.5-65.0）和严重的MRI异常（OR = 0.24, CI 0.13-0.44）是SFD的强预测因子（AUC = 0.95）。结论：死亡率和SFD发生率低于随机对照试验。癫痫发作和严重的MRI异常预示着不良的预后。需要进一步的随机对照试验来完善治疗标准。
Real-World Therapeutic Hypothermia for Neonatal HIE: Neurodevelopmental Outcomes and Predictors.
Aim: This study assessed neurodevelopmental outcomes in neonates with hypoxic-ischemic encephalopathy (HIE) treated with therapeutic hypothermia (TH) outside randomised controlled trials (RCTs). It also aimed to identify predictors of outcomes and evaluate TH practices across centres.
Methods: A prospective, area-based observational study was conducted in eight Italian NICUs (2016-2021), including neonates treated with TH for any grade of HIE. A 2-year neurodevelopmental follow-up was performed. Severe functional disability (SFD) was defined as cerebral palsy (Gross Motor Function Classification Level > 2), cognitive score < 2 SD, bilateral blindness/deafness, or epilepsy. Demographic, clinical and MRI data were analysed.
Results: Among 283 cooled infants, 11 (3.8%) died and 272 (96.2%) survived. HIE severity was mild (14.0%), moderate (76.1%) and severe (9.9%). Follow-up data were available for 232 (85.3%) survivors, with SFD diagnosed in 27 (11.6%). No infants with mild HIE developed SFD. Severe MRI anomalies were found in 51.9% of SFD cases, while 90.7% of non-SFD children had normal findings. cEEG/aEEG-confirmed seizures (OR = 12.9, CI 3.5-65.0) and severe MRI anomalies (OR = 0.24, CI 0.13-0.44) were strong SFD predictors (AUC = 0.95).
Conclusion: Mortality and SFD rates were lower than in RCTs. Seizures and severe MRI anomalies predicted poor outcomes. Further RCTs are needed to refine treatment criteria.
期刊介绍：
Acta Paediatrica is a peer-reviewed monthly journal at the forefront of international pediatric research. It covers both clinical and experimental research in all areas of pediatrics including:
neonatal medicine
developmental medicine
adolescent medicine
child health and environment
psychosomatic pediatrics
child health in developing countries
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