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Viscardi RM, Terrin ML, Magder LS, et al. Randomized trial of azithromycin to eradicate Ureaplasma respiratory colonization in preterm infants: 2-year outcomes. Pediatr Res. 2021;doi: 10.1038/s41390-021-01437-2.
Viscardi, R. M., Terrin, M. L., Magder, L. S., Davis, N. L., Dulkerian, S. J., Waites, K. B., Allen, M., Ajayi-Akintade, A., Ambalavanan, N., Kaufman, D. A., Donohue, P., Tuttle, D. J., & Weitkamp, J. H. (2021). Randomized trial of azithromycin to eradicate Ureaplasma respiratory colonization in preterm infants: 2-year outcomes. Pediatric research, . https://doi.org/10.1038/s41390-021-01437-2
Viscardi, Rose M, et al. "Randomized trial of azithromycin to eradicate Ureaplasma respiratory colonization in preterm infants: 2-year outcomes." Pediatric research vol. (2021). doi: https://doi.org/10.1038/s41390-021-01437-2
Viscardi RM, Terrin ML, Magder LS, Davis NL, Dulkerian SJ, Waites KB, Allen M, Ajayi-Akintade A, Ambalavanan N, Kaufman DA, Donohue P, Tuttle DJ, Weitkamp JH. Randomized trial of azithromycin to eradicate Ureaplasma respiratory colonization in preterm infants: 2-year outcomes. Pediatr Res. 2021 Mar 03; doi: 10.1038/s41390-021-01437-2. Epub 2021 Mar 03. PMID: 33658655; PMCID: PMC8413397.
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Pediatr Res. 2021 Mar 03; doi: 10.1038/s41390-021-01437-2. Epub 2021 Mar 03.

Randomized trial of azithromycin to eradicate Ureaplasma respiratory colonization in preterm infants: 2-year outcomes.

Pediatric research

Rose M Viscardi, Michael L Terrin, Laurence S Magder, Natalie L Davis, Susan J Dulkerian, Ken B Waites, Marilee Allen, Ajoke Ajayi-Akintade, Namasivayam Ambalavanan, David A Kaufman, Pamela Donohue, Deborah J Tuttle, Jörn-Hendrik Weitkamp

Affiliations

  1. Department of Pediatrics, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA. [email protected].
  2. Department of Epidemiology and Preventive Medicine, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.
  3. Department of Pediatrics, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.
  4. Departments of Pathology and Pediatrics, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.
  5. Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  6. Mount Washington Pediatric Hospital, Baltimore, MD, USA.
  7. Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, VA, USA.
  8. Department of Pediatrics, Christiana Care Health System, Newark, DE, USA.
  9. Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.

PMID: 33658655 PMCID: PMC8413397 DOI: 10.1038/s41390-021-01437-2

Abstract

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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