Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial.
<h4>Background</h4>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 ou...
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2023-01-01
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| Series: | PLOS Global Public Health |
| Online Access: | https://doi.org/10.1371/journal.pgph.0001009 |
| _version_ | 1797696379215151104 |
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| author | Mamadou Bountogo Ali Sié Alphonse Zakane Guillaume Compaoré Thierry Ouédraogo Jessica Brogdon Elodie Lebas Fanice Nyatigo Melissa M Medvedev Benjamin F Arnold Thomas M Lietman Catherine E Oldenburg NAITRE Study Team |
| author_facet | Mamadou Bountogo Ali Sié Alphonse Zakane Guillaume Compaoré Thierry Ouédraogo Jessica Brogdon Elodie Lebas Fanice Nyatigo Melissa M Medvedev Benjamin F Arnold Thomas M Lietman Catherine E Oldenburg NAITRE Study Team |
| author_sort | Mamadou Bountogo |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methods</h4>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.<h4>Findings</h4>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.<h4>Interpretation</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov NCT03682653. |
| first_indexed | 2024-03-12T03:25:32Z |
| format | Article |
| id | doaj.art-f0ecd79dff964ac9a84c49a96ed886eb |
| institution | Directory Open Access Journal |
| issn | 2767-3375 |
| language | English |
| last_indexed | 2024-03-12T03:25:32Z |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLOS Global Public Health |
| spelling | doaj.art-f0ecd79dff964ac9a84c49a96ed886eb2023-09-03T13:41:47ZengPublic Library of Science (PLoS)PLOS Global Public Health2767-33752023-01-0135e000100910.1371/journal.pgph.0001009Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial.Mamadou BountogoAli SiéAlphonse ZakaneGuillaume CompaoréThierry OuédraogoJessica BrogdonElodie LebasFanice NyatigoMelissa M MedvedevBenjamin F ArnoldThomas M LietmanCatherine E OldenburgNAITRE Study Team<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Findings</h4>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.<h4>Interpretation</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov NCT03682653.https://doi.org/10.1371/journal.pgph.0001009 |
| spellingShingle | Mamadou Bountogo Ali Sié Alphonse Zakane Guillaume Compaoré Thierry Ouédraogo Jessica Brogdon Elodie Lebas Fanice Nyatigo Melissa M Medvedev Benjamin F Arnold Thomas M Lietman Catherine E Oldenburg NAITRE Study Team 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 |
| title | Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial. |
| title_full | Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial. |
| title_fullStr | Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial. |
| title_full_unstemmed | Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial. |
| title_short | Infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates: A subgroup analysis of a randomized controlled trial. |
| title_sort | infant mortality and growth failure after oral azithromycin among low birthweight and underweight neonates a subgroup analysis of a randomized controlled trial |
| url | https://doi.org/10.1371/journal.pgph.0001009 |
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