ArticleNEJM evidence2022
Neonatal azithromycin administration for prevention of infant mortality.
Article in NEJM evidence, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03682653 (Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Can the use of azithromycin during labour reduce the incidence of infection among puerperae and newborns? A systematic review and meta-analysis of randomized controlled trials.BMC pregnancy and childbirth · 2024Pooled it
- Integration of azithromycin mass administration to 1-11-month-old children into an existing health platform to reduce child mortality: a cluster-randomised trial in Burkina Faso.BMJ global health · 2026Trial
- Azithromycin for infants at risk of poor growth and development: A pooled secondary analysis of two randomized controlled trials.PloS one · 2025Trial
- Cause-Specific Mortality among Infants in a Randomized Controlled Trial of Azithromycin Compared to Placebo for Prevention of Mortality.The American journal of tropical medicine and hygiene · 2024Trial
- Neonatal Azithromycin Exposure and Childhood Growth: Long-Term Follow-Up of a Randomized Controlled Trial.The American journal of tropical medicine and hygiene · 2024Trial
- Neonatal anthropometric indicators of infant growth and mortality in Burkina Faso.Public health nutrition · 2024Trial
- Trial
- Single-dose azithromycin for infant growth in Burkina Faso: Prespecified secondary anthropometric outcomes from a randomized controlled trial.PLoS medicine · 2024Trial
- Neonatal Azithromycin Administration and Growth during Infancy: A Randomized Controlled Trial.The American journal of tropical medicine and hygiene · 2023Trial
- Trial
- Effect of Neonatal Azithromycin on All-Cause and Cause-Specific Infant Mortality: A Randomized Controlled Trial.The American journal of tropical medicine and hygiene · 2022Trial
- Safety and Efficacy of Oral Azithromycin for Gastrointestinal Dysmotility in Pediatric Patients.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Postnatal Azithromycin Is Neuroprotective and Anti-Inflammatory in a Piglet Model of Hypoxic-Ischemic Encephalopathy.Stroke · 2026Article
- Geographic spillover of antimicrobial resistance from mass distribution of azithromycin.Nature communications · 2026Article
- A single dose of azithromycin versus placebo for malaria in infants: A cluster-randomized trial.PLOS global public health · 2026Article
- Mass azithromycin distribution and nutritional status among children aged 1-59 months: A secondary analysis of a cluster randomized trial.PLOS global public health · 2026Article
- Whose burden, whose benefit? Revisiting ethical trade-offs in the WHO guidelines on scaling up mass azithromycin administration.PLoS medicine · 2025Article
- Geographic spillover of antimicrobial resistance from mass distribution of azithromycin.medRxiv : the preprint server for health sciences · 2025Article
- Associations between Antenatal Care Visit Attendance and Infant Mortality and Growth.The American journal of tropical medicine and hygiene · 2024Article
- Mass azithromycin for prevention of child mortality among children with acute malnutrition: A subgroup analysis of a cluster randomized controlled trial.PLOS global public health · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBiannual mass azithromycin administration reduces all-cause childhood mortality in some sub-Saharan African settings, with the largest effects in children 1 to 5 months of age. Azithromycin has not been distributed to children younger than 1 month of age because of the risk of infantile hypertrophic pyloric stenosis (IHPS).
methodsIn this 1:1 placebo-controlled trial, neonates 8 to 27 days of age were randomly assigned to a single oral dose of azithromycin (20 mg/kg) or an equivalent volume of placebo in five regions of Burkina Faso during 2019 and 2020. The primary outcome was all-cause mortality at 6 months of age. Infants were evaluated at 21 days after treatment and at 3 and 6 months of age for vital status; family and provider surveillance for IHPS continued throughout.
resultsOf 21,832 enrolled neonates, 10,898 were allocated to azithromycin and 10,934 to placebo. At 6 months of age, 92 infants had died: 42 (0.44%) in the azithromycin group and 50 (0.52%) in the placebo group (hazard ratio, 0.85; 95% confidence interval [CI], 0.56 to 1.28; P=0.46). A single IHPS case was detected, which was in the azithromycin arm. Serious adverse events, including death and hospitalization within 28 days of treatment, occurred in 0.27% of infants in the azithromycin group and 0.14% in the placebo group, for an absolute risk difference of 0.14 percentage points (95% CI, 0.01 to 0.26).
conclusionsOverall mortality was lower than anticipated when the trial was designed, thus limiting its power. The available data do not support the routine use of azithromycin for the prevention of mortality in neonates in sub-Saharan African settings similar to the one in which this trial was conducted. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT03682653.)
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.