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Parents of babies who participated in an invasive clinical study report a positive experience: the Glucose in Well Babies (GLOW) study
  1. Alana R Cumberpatch1,
  2. Philip J Weston1,
  3. Jane E Harding2,
  4. Deborah L Harris2,3
  1. 1Newborn Intensive Care Unit, Waikato District Health Board, Hamilton, New Zealand
  2. 2Liggins Institute, University of Auckland, Auckland, New Zealand
  3. 3School of Nursing, Midwifery and Health Practice, Faculty of Health, Victoria University of Wellington, Wellington, New Zealand
  1. Correspondence to Dr Deborah L Harris, School of Nursing, Midwifery and Health Practice, Faculty of Health, Victoria University of Wellington, Wellington 6242, New Zealand; Deborah.Harris{at}vuw.ac.nz

Abstract

Objective There is a paucity of data about normal blood metabolite concentrations in healthy babies, in part because of a reluctance to undertake non-therapeutic invasive testing in newborns. The Glucose in Well Babies study (GLOW) sought to describe blood glucose, lactate and beta-hydroxybutyrate concentrations in healthy term babies over the first 5 postnatal days. We also sought to understand both parents’ experience of participation in this invasive non-therapeutic study.

Design, setting, patients and interventions Eligible babies were healthy, term, appropriately grown singletons born in a birthing centre, hospital or home within the greater Hamilton area and then discharged home. Babies had subcutaneous continuous glucose monitoring placed soon after birth, up to 14 heel-prick blood samples, twice-daily home visits and parents were asked to record all feeds. At study completion, both parents were asked to independently complete a questionnaire about their experience.

Results All eligible babies completed the study and every parent completed the questionnaire (65 fathers, 66 mothers). Parents reported they liked contributing to improving healthcare (126/131, 96%) and support from the GLOW team (119/131, 91%). Nearly all (127/131, 97%) would participate in GLOW again if they had another eligible baby, and all would recommend GLOW to family and friends. Two-thirds of parents (87/131, 66%) reported that participation had made them more likely to contribute to clinical research in the future.

Conclusions Non-therapeutic studies involving invasive procedures in healthy term babies are feasible, and parents were positive about their experience.

  • parent consent
  • healthy participants
  • ethics
  • blood glucose concentrations
  • neonate
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Footnotes

  • Twitter @DeborahHarris13

  • Contributors AC contributed to the data collection, analysis and interpretation, wrote the first draft of the manuscript and contributed to the subsequent revisions. PW contributed to the study design, data collection, statistical analysis and interpretation and writing the manuscript. JH contributed to the study design, data analysis, interpretation and writing the manuscript. DH contributed the study design, data collection, analysis, interpretation and to writing manuscript, in addition to having overall responsibility for the Glucose in Well Babies study.

  • Funding This study was funded by the Waikato Sick Babies Trust and Waikato Medical Research Foundation (grant numbers 243 and 268).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The Glucose in Well Babies (GLOW) study was approved by the Northern A Regional Ethics Committee reference 15/NTA/104 and registered with the Australian and New Zealand Clinical Trials Registry ACTRN12615000986572.

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

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.

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