Trial reportFrontiers in neurology
A randomized controlled double-blind study on the brain protection of infantile patients with epileptic spasm syndrome through atomized inhalation of hydrogen-oxygen gas.
Trial report in Frontiers in neurology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 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).
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