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Tributyrin ester-impregnated pH strips for confirming neonatal feeding tube placement: a diagnostic test accuracy study
  1. Jayanta Banerjee1,2,3,4,
  2. Anna McLister5,
  3. Batia Gourin1,6,
  4. Zoe McClure1,6,
  5. Kirupalini Mariampillai1,6,
  6. Robert J Boyle7,
  7. George B Hanna5,
  8. Melody Z Ni5
  1. 1 Neonatology, Imperial College Healthcare NHS Trust, London, UK
  2. 2 Institute of Reproductive and Developmental Biology, Imperial College London, Department of Metabolism, Digestion and Reproduction, London, UK
  3. 3 Biomedical Research Centre, Imperial College Healthcare NHS Trust, London, UK
  4. 4 Origins of Child Health and Disease, Centre for Paediatrics and Child Health, Imperial College London, London, UK
  5. 5 Department of Surgery and Cancer, Imperial College London, London, UK
  6. 6 Children's Clinical Research Facility, Imperial College Healthcare NHS Trust, London, UK
  7. 7 National Heart and Lung Institute, Imperial College London, Faculty of Medicine—South Kensington Campus, London, UK
  1. Correspondence to Dr Jayanta Banerjee, Neonatology, Imperial College Healthcare NHS Trust, London, W2 1NY, UK; jayanta.banerjee{at}

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Nasogastric (NGT) or orogastric (OGT) tubes are the primary mode of feeding in term born sick infants and preterm infants during the postnatal period. Incorrect tube placement in the respiratory tract can lead to life-threatening aspiration. Following the UK National Patient Safety Agency1 and American Society for parenteral and enteral nutrition (ASPEN)2 guidance, current best practice relies on a pH ≤5.5 of the gastric aspirate to confirm gastric placement and requires a chest radiograph if pH is >5.5.

A new pH strip augmented with human gastric lipase (HGL) detection has been developed to improve the sensitivity of gastric tube pH testing (Ingenza, UK) by impregnating standard pH test strips (GBUK Enteral) with 1% tributyrin. In the presence of HGL, produced only in stomach, tributyrin ester is hydrolysed to release butyric acid. If gastric aspirate pH is >5.5, the presence of HGL will help reduce pH to ≤5.5, increasing the sensitivity of the assay. The use of tributyrin ester-mpregnated strips has been validated in adult hospitalised patients,3 but not been evaluated in the neonatal setting, where …

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  • Contributors JB had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Funding: GBH, MZN, RJB, JB Concept and design: MZN, GBH, JB, AML, Boyle,.Acquisition, analysis, or interpretation of data: JB, MZN, AML, BG, ZMC, KM Drafting of the manuscript: JB, MZN, AML, BG, ZMC, KM, RJB, GBH. Critical revision of the manuscript for important intellectual content: JB, MZN, AML, BG, ZMC, KM, RJB, GBH. Statistical analysis: MZN, AML, JB. Administrative, technical, or material support: MZN, AML, BG, ZMC, KM, RJB. Supervision: JB, MZN and AML.

  • Funding This study was funded by UK Research and Innovation (Innovate UK, Biomedical Catalyst 2018 Round two, Ref no 105292) and NIHR Imperial Biomedical Research Centre (FR400). The study was supported by Ingenza Limited, Roslin Innovation Centre, Roslin, EH25 9RG and the English National institute for Health Research (NIHR) Medtech and In vitro diagnostics Co-operative (MICs) program.

  • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests JB is supported by the Imperial Biomedical Research Centre, Imperial College Healthcare NHS Trust, to run neonatal research studies. RJB declares receiving consultancy payments from Cochrane, Wiley and sons, the British Society for Allergy and Clinical Immunology and Prota Therapeutics and expert witness fees for cases related to anaphylaxis and infant nutrition claims, all unrelated to this study. The other authors have no financial or ethical conflicts of interest relevant to this article to declare. Ingenza Limited provided the pH testing kits for the study and participated in the trial management group meetings and reviewed the draft study manuscript.

  • Provenance and peer review Not commissioned; externally peer reviewed.