Literature DB >> 33188430

Safety and Ethics in Endoscopic Studies in Children: Evidence From the BEECH Study in Zambia.

Kanta Chandwe1, Beatrice Amadi1, Miyoba Chipunza1, Masuzyo Zyambo2, Paul Kelly1,3.   

Abstract

BACKGROUND: Environmental enteropathy is an example of a poorly-understood intestinal disorder affecting millions of children worldwide, characterized by malabsorption and stunting. Although there is increasing interest in non-invasive means of assessing intestinal structure and function, the potential value of intestinal biopsy for histology, immunostaining, RNA sequencing and epigenetic work means that endoscopic biopsy remains extremely valuable. We here report our experience in the BEECH (Biomarkers of Environmental Enteropathy in CHildren) study of stunting in Zambia, in the belief that it may help address the knowledge gap regarding the safety of endoscopic biopsy in vulnerable young children.
METHODS: We report our experience of safety in 119 children undergoing endoscopic biopsy in the BEECH study in Lusaka Children's Hospital, Lusaka, and discuss ethical considerations in this light.
RESULTS: Upper gastrointestinal endoscopy was performed on children with stunting (length-for-age z score -2 or less) not responsive to nutritional interventions. Conscious sedation was provided by anaesthetists. Of 119 children, 5 (4%) developed transient desaturation, but no serious adverse events were experienced; no clinical, demographic or anaesthetic characteristics were identified as predictive of desaturation. Two children derived clinically useful information from the endoscopy, one life-saving. Of 105 lactase tests, 59 (54%) showed hypolactasia. DISCUSSION: Children with stunting underwent endoscopy safely, and some derived clinical benefit. Safety and the possibility of clinical benefit are usually felt to be preconditions for the ethical justification for endoscopy for research in children, and we believe that these conditions were met in this study.
© The Author(s) [2020]. Published by Oxford University Press.

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Year:  2021        PMID: 33188430      PMCID: PMC7948385          DOI: 10.1093/tropej/fmaa074

Source DB:  PubMed          Journal:  J Trop Pediatr        ISSN: 0142-6338            Impact factor:   1.165


  46 in total

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Journal:  Lancet Glob Health       Date:  2018-01-29       Impact factor: 26.763

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  4 in total

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Journal:  J Pediatr Gastroenterol Nutr       Date:  2021-10-28       Impact factor: 3.288

2.  Helicobacter pylori infection and hypochlorhydria in Zambian adults and children: A secondary data analysis.

Authors:  Phoebe Hodges; Paul Kelly; Violet Kayamba
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4.  Epithelial Abnormalities in the Small Intestine of Zambian Children With Stunting.

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