Evidence map›Paper›PMID 33658655›Full record

Trial reportPediatric research2022

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

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 and 3 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Azithromycin for eradication ofArchives of disease in childhood. Fetal and neonatal edition · 2026
    Pooled it
  3. Pooled it
  4. Trial
  5. International journal of molecular sciences · 2026
    Review
  6. Review
  7. Review
  8. [Advances in clinical pharmacotherapy for neonatalZhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2025
    Review
  9. Article
  10. Article
  11. Azithromycin for Eradication ofThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023
    Article
  12. Article
  13. MaternalFrontiers in pediatrics · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

Rose M ViscardiDepartment of Pediatrics, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA. rviscard@som.umaryland.edu.ORCID http://orcid.org/0000-0001-7451-6059
Michael L TerrinDepartment of Epidemiology and Preventive Medicine, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.
Laurence S MagderDepartment of Epidemiology and Preventive Medicine, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.
Natalie L DavisDepartment of Pediatrics, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.
Susan J DulkerianDepartment of Pediatrics, University of Maryland, Baltimore School of Medicine, Baltimore, MD, USA.
Ken B WaitesDepartments of Pathology and Pediatrics, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.
Marilee AllenDepartment of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Ajoke Ajayi-AkintadeMount Washington Pediatric Hospital, Baltimore, MD, USA.
Namasivayam AmbalavananDepartments of Pathology and Pediatrics, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.
David A KaufmanDepartment of Pediatrics, University of Virginia School of Medicine, Charlottesville, VA, USA.
Pamela DonohueDepartment of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Deborah J TuttleDepartment of Pediatrics, Christiana Care Health System, Newark, DE, USA.
Jörn-Hendrik WeitkampDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
University of Maryland, Baltimore · USJohns Hopkins University · USUniversity of Alabama at Birmingham · USChristiana Care Health System · USMt. Washington Pediatric Hospital · USUniversity of Virginia · USVanderbilt University Medical Center · US

Funding

Azithromycin To Prevent BPD In Ureaplasma-Infected PretermsR01HD067126 · NICHD · UNIVERSITY OF MARYLAND BALTIMORE · PI DAVIS, NATALIE LOUISE, TERRIN, MICHAEL L · 2011 to 2019
$4.7M
NICHD NIH HHS R01 HD067126
6 · The paper itself

Abstract

backgroundTo 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.

methodsRespiratory 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.

resultsOne 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).

conclusionsWe 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.

Indexed as

Infant, PrematureAnti-Bacterial AgentsAzithromycinDouble-Blind MethodHumansInfantInfant, NewbornLungPlacebosUreaplasma InfectionsAnti-Bacterial AgentsAzithromycinPlacebos

Identifiers

PMID33658655
PMCPMC8413397
OpenAlexW3135891733

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.