Bountogo, Mamadou; Sié, Ali; Zakane, Alphonse; Compaoré, Guillaume; Ouédraogo, Thierry; Brogdon, Jessica; Lebas, Elodie; Nyatigo, Fanice; Medvedev, Melissa M; Arnold, Benjamin F; +3 more... Lietman, Thomas M; Oldenburg, Catherine E; NAITRE Study Team; (2023) Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial. PLOS Global Public Health, 3 (5). e0001009-. ISSN 2767-3375 DOI: https://doi.org/10.1371/journal.pgph.0001009
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Abstract
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.
Item Type | Article |
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Faculty and Department | Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology & International Health (2023-) |
PubMed ID | 37186577 |
Elements ID | 217004 |
Official URL | http://dx.doi.org/10.1371/journal.pgph.0001009 |
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