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Neurodevelopmental Pediatric Follow-Up After the Azithromycin Prevention in Labor Use Study.

Manimaran Ramani1, Waldemar A Carlo, Musaku Mwenechanya

  • 1University of Alabama at Birmingham, Birmingham, Alabama; the University of South Alabama, Mobile, Alabama; the University Teaching Hospital, Lusaka, Zambia; the Jawaharlal Nehru Medical College KLE Academy of Higher Education and Research, Belagavi, the Lata Medical Research Foundation, Nagpur, Maharashtra, and the Datta Meghe Institute of Higher Education and Research, Wardha, India; the Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania; the University of North Carolina School of Medicine, Chapel Hill, and RTI International and the Duke University School of Medicine, Durham, North Carolina; the Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo; the University of Colorado Anschutz Medical Campus Aurora, Aurora, Colorado; Instituto de Nutrición de Centro América y Panamá, Guatemala City, Guatemala; the Boston University School of Public Health, Boston, Massachusetts; Aga Khan University, Karachi, Sindh, and the Jinnah Postgraduate Medical College, Karachi, Pakistan; and the Columbia University School of Medicine, New York, New York.

Obstetrics and Gynecology
|May 14, 2026
PubMed
Summary
This summary is machine-generated.

A single dose of intrapartum azithromycin for mothers did not improve neurodevelopmental outcomes in infants with birth asphyxia. This study found no significant differences in cognitive, language, or motor scores at two years of age.

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Area of Science:

  • Neonatal care
  • Pediatric neurology
  • Pharmacology

Background:

  • Birth asphyxia poses significant risks to infant neurodevelopment.
  • Intrapartum antibiotics are sometimes used, but their impact on neurodevelopmental outcomes is not fully understood.
  • The Azithromycin Prevention in Labor Use Study (A-PLUS) investigated intrapartum azithromycin use.

Purpose of the Study:

  • To assess if a single 2g dose of intrapartum azithromycin administered to laboring mothers impacts neurodevelopmental outcomes in infants experiencing birth asphyxia.
  • To evaluate the effect of maternal intrapartum azithromycin on cognitive, language, and motor development at 24 months corrected age.

Main Methods:

  • A follow-up study of children born at ≥34 weeks gestation with suspected birth asphyxia, whose mothers participated in the A-PLUS trial.
  • Mothers were randomized to receive either 2g oral azithromycin or placebo during labor.
  • Neurodevelopmental outcomes were assessed using the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III) and Ages & Stages Questionnaires, 3rd Edition (ASQ-3) at 24±1 months corrected age.

Main Results:

  • No significant difference in the primary outcome, the Cognitive Composite Score (CCS) of the BSID-III, was observed between the azithromycin and placebo groups (90.9 vs 90.9).
  • Secondary outcomes, including the Language Composite Score (LCS) and Motor Composite Score (MCS) of the BSID-III, and ASQ-3 scores, also showed no significant differences between groups.
  • Subgroup analyses by region did not reveal any differences in neurodevelopmental outcomes between the treatment arms.

Conclusions:

  • A single oral dose of 2g azithromycin given to laboring mothers did not improve neurodevelopmental outcomes in neonates with birth asphyxia at two years of age.
  • The findings suggest that intrapartum azithromycin, in this context, does not confer a neurodevelopmental benefit to at-risk infants.