Randomized trial of azithromycin to eradicate Ureaplasma respiratory colonization in preterm infants: 2-year outcomes
Rose M Viscardi1, Michael L Terrin2, Laurence S Magder2
1Department of Pediatrics, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA. rviscard@som.umaryland.edu.
Insights
Azithromycin treatment in the first week of life did not significantly alter 2-year pulmonary and neurodevelopmental outcomes in preterm infants. However, Ureaplasma colonization was linked to increased respiratory morbidity in these infants.
Area of Science:
- Neonatal Medicine
- Pediatric Pulmonology
- Infectious Diseases
Background:
- Preterm infants are susceptible to respiratory infections and colonization by microorganisms like Ureaplasma.
- Early antibiotic intervention, such as azithromycin, is being investigated for its potential benefits in this vulnerable population.
- Understanding the long-term effects of early azithromycin on respiratory and neurodevelopmental outcomes is crucial.
Purpose of the Study:
- To evaluate the impact of early-life azithromycin treatment on 2-year outcomes in preterm infants.
- To assess the influence of Ureaplasma respiratory colonization on these outcomes.
- To determine if azithromycin affects the relationship between Ureaplasma and infant morbidity.
Main Methods:
- A double-blind, placebo-controlled randomized controlled trial was conducted.
- Participants included preterm infants with and without Ureaplasma respiratory colonization.
- Outcomes assessed included respiratory morbidity and neurodevelopmental impairment up to 26 months corrected age.
Main Results:
- No significant differences were observed in death or severe respiratory morbidity between azithromycin and placebo groups.
- Similarly, no significant differences were found in death or moderate-severe neurodevelopmental impairment.
- Infants with Ureaplasma colonization showed a higher frequency of death or serious respiratory morbidity.
Conclusions:
- Early azithromycin treatment did not demonstrate a significant impact on long-term pulmonary and neurodevelopmental outcomes in preterm infants.
- Ureaplasma colonization in the lower respiratory tract is associated with increased serious respiratory morbidity in the first two years of life.
- Further research, including a Phase III trial targeting Ureaplasma-positive infants, is warranted to explore azithromycin's potential in preventing Bronchopulmonary Dysplasia (BPD).
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.
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