Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso

Summary

Although under-5 mortality rates are declining globally, neonatal mortality remains persistently high in many regions of sub-Saharan Africa. Mass azithromycin distribution to children aged 1-59 months has been shown to reduce childhood mortality in Niger, Tanzania, and Malawi. This study did not evaluate the effect of azithromycin administered during the neonatal period. Observational evidence from high income countries has suggested that macrolides, including erythromycin and azithromycin, may be associated with increased risk of development of infantile hypertrophic pyloric stenosis (IHPS). However, these studies are limited by confounding by indication, as infants only receive antibiotics when they are ill. The investigators proposed an individually randomized trial of azithromycin versus placebo to establish the efficacy and safety of administration of a dose of azithromycin during the neonatal period. The long-term goal is generate evidence that can be used by neonatal and child survival programs related to the use of azithromycin in the youngest children who have the highest risk of mortality. The investigators hypothesize that a single dose of azithromycin administered in the neonatal period will lead to significantly reduced risk of mortality and that this dose will be safe. Objectives 1. Establish the efficacy of a single dose of azithromycin administered during the neonatal period compared to placebo in infants 8 to 27 days of life for reduction in all-cause mortality. 2. Establish the safety of a single dose of azithromycin administered during the neonatal period. This study will be conducted in several regions of Burkina Faso, including peri-urban areas of Ouagadougou and Nouna town, and rural areas that are within 4 hours' drive of a pediatric facility with capacity for performing pyloromyotomy

Timeline

Start

2019-04-11

Primary completion

2022-05-01

Completion

2022-12-31

Publications

• Bountogo M, Sie A, Zakane A, Compaore G, Ouedraogo T, Brogdon J, Lebas E, Nyatigo F, Medvedev MM, Arnold BF, Lietman TM, Oldenburg CE; 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 Glob Public Health. 2023 May 15;3(5):e0001009. doi: 10.1371/journal.pgph.0001009. eCollection 2023.
• Sie A, Bountogo M, Zakane A, Compaore G, Ouedraogo T, Ouattara M, Lebas E, Brogdon J, Nyatigo F, O'Brien KS, Porco TC, Barnighausen T, Arnold BF, Lietman TM, Oldenburg CE; NAITRE Study Team. Neonatal Azithromycin Administration and Growth during Infancy: A Randomized Controlled Trial. Am J Trop Med Hyg. 2023 Mar 27;108(5):1063-1070. doi: 10.4269/ajtmh.22-0763. Print 2023 May 3.
• Oldenburg CE, Sie A, Bountogo M, Zakane A, Compaore G, Ouedraogo T, Koueta F, Lebas E, Brogdon J, Nyatigo F, Doan T, Porco TC, Arnold BF, Lietman TM; NAITRE Study Team. Neonatal azithromycin administration for prevention of infant mortality. NEJM Evid. 2022 Apr;1(4):EVIDoa2100054. doi: 10.1056/EVIDoa2100054. Epub 2022 Mar 17.
• Bountogo M, Sie A, Zakane A, Compaore G, Ouedraogo T, Lebas E, Brogdon J, Nyatigo F, Arnold BF, Lietman TM, Oldenburg CE. Antenatal care attendance and risk of low birthweight in Burkina Faso: a cross-sectional study. BMC Pregnancy Childbirth. 2021 Dec 13;21(1):825. doi: 10.1186/s12884-021-04310-6.
• Sie A, Bountogo M, Nebie E, Ouattara M, Coulibaly B, Bagagnan C, Zabre P, Lebas E, Brogdon J, Godwin WW, Lin Y, Porco T, Doan T, Lietman TM, Oldenburg CE; NAITRE Study Group. Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial. BMJ Open. 2019 Sep 4;9(9):e031162. doi: 10.1136/bmjopen-2019-031162.

Drugs

Indications

No indication recorded.