Neurodevelopmental Pediatric Follow-Up After the Azithromycin Prevention in Labor Use Study.
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Ramani Manimaran, Carlo Waldemar A, Mwenechanya Musaku, Chomba Elwyn, Goudar Shivaprasad S, Derman Richard J, Metgud Mrityunjay C, Kavi Avinash, Bauserman Melissa, Patterson Jackie, Tshefu Antoinette K, Lokangaka Adrien L, Krebs Nancy F, Mazariegos Manolo, Barrientos Diva, Patel Archana B, Hibberd Patricia L, Bhargav Savita, Andelkar Atul, Saleem Sarah, Goldenberg Robert L, Tikmani Shiyam Sunder, Yasmin Haleema, Babineau Denise C, Hemingway-Foday Jennifer J, Trotta Marissa, Rasco Cecilia, McClure Elizabeth M, Gustafson Kathryn E, ABC Study Group
Аннотация
METHODS: This was a neurodevelopmental follow-up study of children born at 34 weeks of gestation or later who had concern for asphyxia and whose mothers were enrolled in A-PLUS (the Azithromycin Prevention in Labor Use Study). Mothers in A-PLUS were randomized to receive a single oral dose of azithromycin (2 g) or placebo during labor. This follow-up to A-PLUS spanned six sites across five countries (India [two sites], Pakistan, Zambia, Democratic Republic of Congo, and Guatemala). Asphyxia was defined as 5-minute Apgar score less than 7 or the need for bag-and-mask ventilation at birth. The primary outcome was the CCS (Cognitive Composite Score) of the BSID-III (Bayley Scales of Infant and Toddler Development, 3rd Edition) at a corrected age of 24±1 months. Secondary outcomes included the LCS (Language Composite Score) and MCS (Motor Composite Score) of the BSID-III at a corrected age of 24±1 months. Masked examiners administered the BSID-III and the ASQ-3 (Ages & Stages Questionnaires, 3 rd Edition). Outcomes were analyzed using a generalized linear model and were adjusted for site, gestational age at delivery, and maternal and child baseline characteristics that differed between treatment groups.
RESULTS: Of 529 eligible mother-child dyads screened, 403 (197 in the azithromycin arm and 206 in the placebo arm) were enrolled and completed the neurodevelopmental follow-up at a corrected age of 24±1 months. The primary outcome, the CCS of the BSID-III, did not differ significantly between groups (azithromycin: 90.9±11.2 vs placebo: 90.9±11.7; mean difference: 0.29; 95% CI, -1.77 to 2.34). No significant differences were observed between treatment arms in the BSID-III's LCS and MCS or in the total scores of the ASQ-3's five domains. Subgroup analysis by region (sub-Saharan Africa vs South Asia) also showed no differences in BSID-III or ASQ-3 scores between the azithromycin and placebo groups.
CONCLUSION: In this follow-up study, a single oral dose of azithromycin given to laboring mothers who delivered neonates with birth asphyxia did not improve neurodevelopmental outcomes at 2 years of age.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03871491.