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  • Dextrose gel prophylaxis for neonatal hypoglycaemia and neurocognitive function at early school age: a randomised dosage trial

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Dextrose gel prophylaxis for neonatal hypoglycaemia and neurocognitive function at early school age: a randomised dosage trial
  1. Xingyu Wei1,
  2. Nike Franke1,
  3. Jane M Alsweiler2,
  4. Gavin T L Brown3,
  5. Gregory D Gamble1,
  6. Alicia McNeill1,
  7. Jenny Rogers1,
  8. Benjamin Thompson4,5,
  9. Jason Turuwhenua6,
  10. Trecia A Wouldes7,
  11. Jane E Harding1,
  12. Christopher J D McKinlay2
  13. On behalf of the pre-hPOD Early School-age Outcomes Study Group
  1. 1 Liggins Institute, The University of Auckland, Auckland, New Zealand, Auckland, New Zealand
  2. 2 Paediatrics: Child and Youth Health, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand
  3. 3 Learning, Development and Professional Practice, The University of Auckland, Auckland, New Zealand
  4. 4 Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, Canada
  5. 5 Optometry and Vision Science, University of Auckland, Auckland, New Zealand
  6. 6 Auckland Bioengineering Institute, University of Auckland, Auckland, New Zealand
  7. 7 Department of Psychological Medicine, The University of Auckland, Auckland, New Zealand
  1. Correspondence to Dr Christopher J D McKinlay, Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland 1042, New Zealand; c.mckinlay{at}auckland.ac.nz

Abstract

Objective To investigate the effect of different doses of prophylactic dextrose gel on neurocognitive function and health at 6–7 years.

Design Early school-age follow-up of the pre-hPOD (hypoglycaemia Prevention with Oral Dextrose) study.

Setting Schools and communities.

Patients Children born at ≥35 weeks with ≥1 risk factor for neonatal hypoglycaemia: maternal diabetes, small or large for gestational age, or late preterm.

Interventions Four interventions commencing at 1 hour of age: dextrose gel (40%) 200 mg/kg; 400 mg/kg; 200 mg/kg and 200 mg/kg repeated before three feeds (800 mg/kg); 400 mg/kg and 200 mg/kg before three feeds (1000 mg/kg); compared with equivolume placebo (combined for analysis).

Main outcomes measures Toolbox cognitive and motor batteries, as well as tests of motion perception, numeracy and cardiometabolic health, were used. The primary outcome was neurocognitive impairment, defined as a standard score of more than 1 SD below the age-corrected mean on one or more Toolbox tests.

Findings Of 392 eligible children, 309 were assessed for the primary outcome. There were no significant differences in the rate of neurocognitive impairment between those randomised to placebo (56%) and dextrose gel (200 mg/kg 46%: adjusted risk difference (aRD)=−14%, 95% CI −35%, 7%; 400 mg/kg 48%: aRD=−7%, 95% CI −27%, 12%; 800 mg/kg 45%: aRD=−14%, 95% CI −36%, 9%; 1000 mg/kg 50%: aRD=−8%, 95% CI −29%, 13%). Children exposed to any dose of dextrose gel (combined), compared with placebo, had a lower risk of motor impairment (3% vs 14%, aRD=-11%, 95% CI −19%, −3%) and higher mean (SD) cognitive scores (106.0 (15.3) vs 101.1 (15.7), adjusted mean difference=5.4, 95% CI 1.8, 8.9).

Conclusions Prophylactic neonatal dextrose gel did not alter neurocognitive impairment at early school age but may have motor and cognitive benefits. Further school-age follow-up studies are needed.

  • Neonatology
  • Child Development

Data availability statement

Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal, according to the data sharing protocol of The University of Auckland (https://research-hub.auckland.ac.nz/subhub/human-health-research-services-platform). Proposals should be submitted to dataservices@auckland.ac.nz.

https://doi.org/10.1136/archdischild-2023-326452

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    Data availability statement

    Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal, according to the data sharing protocol of The University of Auckland (https://research-hub.auckland.ac.nz/subhub/human-health-research-services-platform). Proposals should be submitted to dataservices@auckland.ac.nz.

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    Footnotes

    • X @xwei147@aucklanduni.ac.nz

    • Correction notice This paper has been corrected since it was first published. In the section, Secondary analysis: all dextrose gel groups combined, the paragraph below the heading should read ‘3% vs. 14% and 106.0 vs. 101.1’.

    • Contributors Concept and design: JMA, GTLB, GDG, JR, BT, TAW, JEH, CJDM (non-author contributors: JGC, CC, FB, PK, RE, RG, JH). Obtained funding: JMA, GTLB, GDG, JR, BT, TAW, JEH, CJDM (non-author contributor: CC). Developed equipment and materials: JMA, GTLB, AM, JR, BT, JT, JEH, CJDM (non-author contributor: NB). Provided supervision and oversight: NF, JMA, GTLB, AM, JR, BT, TAW, JEH, CJDM (non-author contributors: FB, CC, JGC). Data collection: XW, AM, JR, JT, CJDM (non-author contributors: DD, OI, RL, JL, SM, AM, DN, HP, RS). Analysis: XW, JMA, GDG, JEH, CJDM. Writing: XW, NF, JMA, GDG, JR, JEH, CJDM. Review and approval: all authors critically reviewed and approved the final manuscript. Guarantor: CJDM.

    • Funding This study was funded by the Health Research Council of New Zealand (19/960) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health (R01HD091075). The pre-hPOD trial and 2-year follow-up were funded by Lottery Health Research (241266), Cure Kids (3561), philanthropic donations to the University of Auckland Foundation (F-ILG- LRSR), Health Research Council of New Zealand (15-216), Gravida, National Centre for Growth and Development (SCH-14-14), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health (R01HD091075). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

    • Competing interests None declared.

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

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.