随机试验阿奇霉素根除早产儿脲原体呼吸道定植：2 年结局。
Randomized trial of azithromycin to eradicate Ureaplasma respiratory colonization in preterm infants: 2-year outcomes.
机构信息
Department of Pediatrics, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.
Department of Epidemiology and Preventive Medicine, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.
出版信息
Pediatr Res. 2022 Jan;91(1):178-187. doi: 10.1038/s41390-021-01437-2. Epub 2021 Mar 3.
BACKGROUND
To assess the potential impact of azithromycin treatment in the first week following birth on 2-year outcomes in preterm infants with and without Ureaplasma respiratory colonization who participated in a double-blind, placebo-controlled randomized controlled trial.
METHODS
Respiratory morbidity was assessed at NICU discharge and at 6, 12, and 22-26 months corrected age using pulmonary questionnaires. Comprehensive neurodevelopmental assessments were completed between 22 and 26 months corrected age. The primary and secondary composite outcomes were death or severe respiratory morbidity and death or moderate-severe neurodevelopmental impairment, respectively, at 22-26 months corrected age.
RESULTS
One hundred and twenty-one randomized participants (azithromycin, N = 60; placebo, N = 61) were included in the intent-to-treat analysis. There were no significant differences in death or serious respiratory morbidity (34.8 vs 30.4%, p = 0.67) or death or moderate-severe neurodevelopmental impairment (47 vs 33%, p = 0.11) between the azithromycin and placebo groups. Among all trial participants, tracheal aspirate Ureaplasma-positive infants experienced a higher frequency of death or serious respiratory morbidity at 22-26 months corrected age (58%) than tracheal aspirate Ureaplasma-negative infants (34%) or non-intubated infants (21%) (p = 0.028).
CONCLUSIONS
We did not observe strong evidence of a difference in long-term pulmonary and neurodevelopment outcomes in preterm infants treated with azithromycin in the first week of life compared to placebo.
IMPACT
No strong evidence of a difference in long-term pulmonary and neurodevelopment outcomes was identified at 22-26 months corrected age in infants treated with azithromycin in the first week of life compared to placebo. The RCT is the first study of 2-year pulmonary and neurodevelopmental outcomes of azithromycin treatment in ELGANs. Provides evidence that ELGANs with lower respiratory tract Ureaplasma have the most frequent serious respiratory morbidity in the first 2 years of life, suggesting that a Phase III trial of azithromycin to prevent BPD targeting this population is warranted.
背景
评估出生后第一周阿奇霉素治疗对参与双盲、安慰剂对照随机对照试验的有和无脲原体呼吸道定植的早产儿 2 年结局的潜在影响。
方法
使用肺部问卷在新生儿重症监护病房出院时和 6、12、22-26 个月校正年龄时评估呼吸发病率。在 22-26 个月校正年龄时完成全面的神经发育评估。主要和次要复合结局分别为 22-26 个月校正年龄时死亡或严重呼吸发病率和死亡或中重度神经发育障碍。
结果
121 名随机参与者（阿奇霉素，N=60；安慰剂，N=61）被纳入意向治疗分析。阿奇霉素组和安慰剂组在死亡或严重呼吸发病率（34.8%比 30.4%，p=0.67）或死亡或中重度神经发育障碍（47%比 33%，p=0.11）方面无显著差异。在所有试验参与者中，气管抽吸脲原体阳性婴儿在 22-26 个月校正年龄时经历死亡或严重呼吸发病率的频率较高（58%），而气管抽吸脲原体阴性婴儿（34%）或未插管婴儿（21%）（p=0.028）。
结论
我们没有观察到与安慰剂相比，在生命的第一周用阿奇霉素治疗的早产儿在长期肺部和神经发育结局方面有明显的差异。
影响
与安慰剂相比，在生命的第一周用阿奇霉素治疗的婴儿在 22-26 个月校正年龄时在长期肺部和神经发育结局方面没有明显差异。该 RCT 是第一项关于 ELGANs 阿奇霉素治疗 2 年肺部和神经发育结局的研究。提供了证据表明，下呼吸道脲原体的 ELGANs 在生命的前 2 年有最频繁的严重呼吸发病率，这表明针对该人群的预防 BPD 的阿奇霉素 III 期试验是有必要的。
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