Browsing by Author "McKinlay CJD"

Filter results by typing the first few letters
Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Gestational diabetes detection thresholds and infant growth, nutrition, and neurodevelopment at 12-18 months: a prospective cohort study within a randomized trial
    (Springer Nature Limited, 2025-09-05) Amitrano F; Manerkar K; Alsweiler JM; Conlon CA; Crowther CA; Edlin R; Harding JE; McCowan LME; Meyer MP; Rowan JA; Rush EC; McKinlay CJD
    Objective To assess the impact of gestational diabetes(GDM) detection thresholds on infant growth, nutrition, and neurodevelopment at 12-18 months. Design Prospective cohort study within the GEMS trial(ACTRN12615000290594), which randomized pregnant women to detection of GDM using lower or higher glycemic criteria. The main outcomes were overweight/rapid weight gain; food approach appetitive score; energy intake; cognitive z-score. Result Compared to control infants, those exposed to GDM detected and treated by higher criteria or by lower but not higher criteria that was untreated, were less likely to have increased overweight/rapid weight gain, possibly with lower energy intake. There were no important differences in appetite and cognition. Infants exposed to GDM by lower but not higher criteria that was treated were similar to controls. Conclusion Exposure to treated GDM or untreated GDM detected by lower but not higher criteria, was not associated with increased infant risk factors for obesity or adverse cognitive outcomes.
  • Thumbnail Image
    Item
    Panic or peace - prioritising infant welfare when medicating feverish infants: a grounded theory study of adherence in a paediatric clinical trial
    (BioMed Central Ltd, 2022-04-11) Tan E; Hoare K; Riley J; Fernando K; Haskell L; McKinlay CJD; Dalziel SR; Braithwaite I
    Background Literature on factors influencing medication adherence within paediatric clinical trials is sparse. The Paracetamol and Ibuprofen in the Primary Prevention of Asthma in Tamariki (PIPPA Tamariki) trial is an open-label, randomised controlled trial aiming to determine whether paracetamol treatment, compared with ibuprofen treatment, as required for fever and pain in the first year of life, increases the risk of asthma at age six years. To inform strategies for reducing trial medication crossovers, understanding factors influencing the observed ibuprofen-to-paracetamol crossovers (non-protocol adherence) is vital. The aim of this study was to investigate the factors influencing the decision-making process when administering or prescribing ibuprofen to infants that may contribute to the crossover events in the PIPPA Tamariki trial. Methods Constructivist grounded theory methods were employed. We conducted semi-structured interviews of caregivers of enrolled PIPPA Tamariki infants and healthcare professionals in various healthcare settings. Increasing theoretical sensitivity of the interviewers led to theoretical sampling of participants who could expand on the teams’ early constructed codes. Transcribed interviews were coded and analysed using the constant comparative method of concurrent data collection and analysis. Results Between September and December 2020, 20 participants (12 caregivers; 8 healthcare professionals) were interviewed. We constructed a grounded theory of prioritising infant welfare that represents a basic social process when caregivers and healthcare professionals medicate feverish infants. This process comprises three categories: historical, trusting relationships and being discerning; and is modified by one condition: being conflicted. Participants bring with them historical ideas. Trusting relationships with researchers, treating clinicians and family play a central role in enabling participants to challenge historical ideas and be discerning. Trial medication crossovers occur when participants become conflicted, and they revert to historical practices that feel familiar and safer. Conclusions We identified factors and a basic social process influencing ibuprofen use in infants and trial medication crossover events, which can inform strategies for promoting adherence in the PIPPA Tamariki trial. Future studies should explore the role of trusting relationships between researchers and treating clinicians when conducting research.