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Background <p>Bronchopulmonary dysplasia (BPD) – also termed chronic lung disease of prematurity – remains a principal cause of death and long-term morbidity in very preterm infants. Azithromycin is active against <i>Ureaplasma</i> and has both antibacterial and anti-inflammatory properties, making it a plausible preventive therapy. Evidence, however, is inconclusive. We evaluated whether azithromycin improves survival free of moderate or severe, physiologically defined chronic lung disease in this high-risk population.</p> Methods <p>Following the Cochrane Handbook, we conducted a systematic review and meta-analysis and reported according to PRISMA (PROSPERO <Emphasis Type="Underline">CRD42024589280</Emphasis>). We searched PubMed, SCOPUS, Web of Science, EMBASE, and CENTRAL from inception to April 2024. Dichotomous outcomes were pooled as risk ratios (RRs), and continuous outcomes were pooled as mean differences (MDs) using RevMan 5.4; <i>P</i> &lt; 0.05 denoted statistical significance.</p> Results <p>Seven double-blind randomized controlled trials involving 1,481 infants (azithromycin, <i>n</i> = 740; placebo, <i>n</i> = 741) met the inclusion criteria. Azithromycin did not significantly reduce any primary outcome: BPD (RR, 0.97; 95% CI, 0.85–1.10; I<sup>2</sup> = 35%; 6 trials; 1,221 infants), death or severe BPD (RR, 0.96; 95% CI, 0.84–1.10; <i>I</i><sup>2</sup> = 43%; 7 trials; 1,473 infants), or all-cause mortality (RR, 0.90; 95% CI, 0.68–1.20; <i>I</i><sup>2</sup> = 0%; 6 trials; 1,257 infants). Subgroup analyses showed no interaction by treatment duration (&gt; 7&#xa0;days vs ≤ 7&#xa0;days) or&#xa0;<i>Ureaplasma</i>&#xa0;colonization status (all <i>P</i> &gt; 0.05). Azithromycin also did not improve any prespecified secondary outcome, including necrotizing enterocolitis, retinopathy of prematurity, intraventricular hemorrhage, sepsis, abnormal hearing, respiratory distress syndrome, postnatal corticosteroid use, days of mechanical ventilation, CPAP duration, or length of stay, with one exception: supplemental oxygen duration was reduced by 6.1&#xa0;days (MD, -6.1; 95% CI, -7.45 to -4.77; <i>I</i><sup>2</sup> = 0%; 4 trials; 529 infants). This benefit was observed in the long-course regimen (&gt; 7&#xa0;days) but not in the short-course regimen; however, the test for subgroup difference was not statistically significant (<i>P</i> = 0.82).</p> Conclusion <p>Azithromycin did not improve survival free of moderate or severe BPD, nor did it reduce mortality or most other morbidities in very preterm infants. Although it shortened supplemental oxygen exposure, the overall evidence does not support routine azithromycin use for BPD prevention in this population.</p>

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Efficacy of Azithromycin for Preventing Chronic Lung Disease of Prematurity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

  • 期刊论文

  • 发表日期：

    2026年4月29日

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  • Obieda Altobaishat,
  • Elsayed Balbaa,
  • Moumen Arnaout,
  • Hashem Alsaid Ahmad,
  • Husam Abu Suilik,
  • Abdulrahman Sharaf,
  • Zaid Bataineh,
  • Mohamed Abouzid

摘要

Background

Bronchopulmonary dysplasia (BPD) – also termed chronic lung disease of prematurity – remains a principal cause of death and long-term morbidity in very preterm infants. Azithromycin is active against Ureaplasma and has both antibacterial and anti-inflammatory properties, making it a plausible preventive therapy. Evidence, however, is inconclusive. We evaluated whether azithromycin improves survival free of moderate or severe, physiologically defined chronic lung disease in this high-risk population.

Methods

Following the Cochrane Handbook, we conducted a systematic review and meta-analysis and reported according to PRISMA (PROSPERO CRD42024589280). We searched PubMed, SCOPUS, Web of Science, EMBASE, and CENTRAL from inception to April 2024. Dichotomous outcomes were pooled as risk ratios (RRs), and continuous outcomes were pooled as mean differences (MDs) using RevMan 5.4; P < 0.05 denoted statistical significance.

Results

Seven double-blind randomized controlled trials involving 1,481 infants (azithromycin, n = 740; placebo, n = 741) met the inclusion criteria. Azithromycin did not significantly reduce any primary outcome: BPD (RR, 0.97; 95% CI, 0.85–1.10; I2 = 35%; 6 trials; 1,221 infants), death or severe BPD (RR, 0.96; 95% CI, 0.84–1.10; I2 = 43%; 7 trials; 1,473 infants), or all-cause mortality (RR, 0.90; 95% CI, 0.68–1.20; I2 = 0%; 6 trials; 1,257 infants). Subgroup analyses showed no interaction by treatment duration (> 7 days vs ≤ 7 days) or Ureaplasma colonization status (all P > 0.05). Azithromycin also did not improve any prespecified secondary outcome, including necrotizing enterocolitis, retinopathy of prematurity, intraventricular hemorrhage, sepsis, abnormal hearing, respiratory distress syndrome, postnatal corticosteroid use, days of mechanical ventilation, CPAP duration, or length of stay, with one exception: supplemental oxygen duration was reduced by 6.1 days (MD, -6.1; 95% CI, -7.45 to -4.77; I2 = 0%; 4 trials; 529 infants). This benefit was observed in the long-course regimen (> 7 days) but not in the short-course regimen; however, the test for subgroup difference was not statistically significant (P = 0.82).

Conclusion

Azithromycin did not improve survival free of moderate or severe BPD, nor did it reduce mortality or most other morbidities in very preterm infants. Although it shortened supplemental oxygen exposure, the overall evidence does not support routine azithromycin use for BPD prevention in this population.