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Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial

Article scientifique 2023 Anglais

Résumé

BACKGROUND: Low birthweight (birthweight <2500 grams, g) and underweight (weight-for-age Z-score, WAZ, < -2) infants have higher risk of poor outcomes compared to their well-nourished peers. We evaluated the role of azithromycin for reducing mortality and improving growth outcomes in low birthweight and/or underweight infants. METHODS: Infants aged 8-27 days of age weighing ≥2500 g at enrollment in Burkina Faso were randomized 1:1 to a single, oral dose of azithromycin (20 mg/kg) or matching placebo. We evaluated mortality and anthropometric outcomes in four subgroups: 1) both low birthweight and underweight at enrollment; 2) low birthweight-only; 3) underweight-only; 4) neither low birthweight nor underweight. FINDINGS: Of 21,832 enrolled infants, 21,320 (98%) had birthweight measurements and included in this analysis. Of these, 747 (3%) were both low birthweight and underweight, 972 (5%) were low birthweight-only, 825 (4%) were underweight-only, and 18,776 (88%) were neither low birthweight nor underweight. Infants who were both low birthweight and underweight receiving azithromycin had lower odds of underweight at 6 months compared to placebo (OR 0.65, 95% CI 0.44 to 0.95), but the treatment group by subgroup interaction was not statistically significant (P = 0.06). We did not find evidence of a difference between groups for other outcomes in any subgroup. INTERPRETATION: Azithromycin may have some growth-promoting benefits for the highest risk infants, but we were unable to demonstrate a difference in most outcomes in low birthweight and underweight infants. As a secondary analysis of a trial, this study was underpowered for rare outcomes such as mortality. TRIAL REGISTRATION: ClinicalTrials.gov NCT03682653.

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Bountogo, M., Sié, A., Zakané, A., Compaoré, G., Ouédraogo, T., Brogdon, J., Lebas, E., Nyatigo, F., Medvedev, M., Arnold, B., Lietman, T., Oldenburg, C., Team, f. (2023). Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial. https://doi.org/10.1371/journal.pgph.0001009

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Auteur(s)

Mamadou Bountogo Ali Sié Alphonse Zakané Guillaume Compaoré Thierry Ouédraogo Jessica Brogdon Elodie Lebas Fanice Nyatigo Melissa M. Medvedev Benjamin F. Arnold Thomas M. Lietman Catherine E. Oldenburg for the NAITRE Study Team

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