Objective Hydrogen-oxygen nebulization inhalation has a brain-protective effect. This study aims to evaluate its short-term efficacy and safety as an adjuvant treatment for infantile epileptic spasms syndrome (IESS). Methods A prospective randomized double-blind controlled trial enrolled 53 IESS children (Nov 2021–Nov 2023), randomized via a random number table into a hydrogen-oxygen inhalation group (27 cases, 66.6% H₂/33.3% O₂ nebulization) and an air inhalation group (26 cases, medical air nebulization). Both groups received standard treatment plus 4 daily 1-h interventions for 14 consecutive days. Primary endpoints were spasticity relief and effective rates; secondary endpoints included improvements in high-amplitude abnormal EEG, IL-6 levels, respiratory tract infection rate, and adverse reactions. Statistical analyses used SPSS software. Results The primary efficacy endpoints (spasm relief rate p = 0.705, effective rate p = 0.950) and secondary efficacy endpoints (disappearance rate of electroencephalogram hypsarrhythmia p = 0.576, change in Kramer score p = 0.140, change in BASED score p = 0.168, abnormal IL-6 rate p = 0.081) of the two groups of children were compared. There was no statistically significant difference. The overall incidence of adverse reactions in the two groups was comparable, and no serious adverse events occurred in either group. However, the incidences of elevated myocardial enzymes (28.3% vs. 10.9%), gastrointestinal dysfunction (43.5% vs. 23.9%), and abnormal liver function (8.7% vs. 0%) in the hydrogen-oxygen inhalation group were significantly higher than those in the air inhalation group (all p 0.05). Conclusion Short-term hydrogen-oxygen nebulization inhalation failed to significantly improve the clinical efficacy of standard treatment for children with IESS. Although it is generally safe and feasible, its potential effects on myocardial, liver and gastrointestinal functions of children need to be closely monitored. In the future, large-sample, long-term follow-up multi-center studies need to be carried out to comprehensively evaluate its clinical value. Clinical trial registration http://www.chictr.org.cn/bin/home , identifier (ChiCTR2100047479).
Chen et al. (Thu,) studied this question.