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Outcome at 4.5 years after dextrose gel treatment of hypoglycaemia: follow-up of the Sugar Babies randomised trial
  1. Deborah L Harris1,2,
  2. Greg D Gamble2,
  3. Jane E Harding2
  4. on behalf of the CHYLD Study Group
    1. 1 School of Nursing Midwifery and Health Practice, Victoria University of Wellington, Wellington, New Zealand
    2. 2 Liggins Institute, The University of Auckland, Auckland, New Zealand
    1. Correspondence to Professor Jane E Harding, Liggins Institute, The University of Auckland, Auckland, Auckland, New Zealand; j.harding{at}auckland.ac.nz

    Abstract

    Objective Dextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown.

    Design and setting Follow-up of participants in a randomised trial recruited in a tertiary centre and assessed in a research clinic.

    Patients Children who were hypoglycaemic (<2.6 mmol/L) recruited to the Sugar Babies Study (>35 weeks, <48 hours old) and randomised to treatment with 40% dextrose or placebo gel.

    Interventions Assessment of neurological status, cognitive ability (Weschler Preschool and Primary Scale of Intelligence), executive function (five tasks), motor function (Movement Assessment Battery for Children-2 (MABC-2)), vision, visual processing (Beery-Buktenica Development Test of Visual Motor Integration (Beery VMI) and motion coherence thresholds) and growth at 2 years.

    Main outcome measures Neurosensory impairment (cerebral palsy; visual impairment; deafness; intelligence quotient <85; Beery VMI <85; MABC-2 score <15th centile; low performance on executive function or motion coherence).

    Results Of 237 babies randomised, 185 (78%) were assessed; 96 randomised to dextrose and 89 to placebo gel. Neurosensory impairment was similar in both groups (dextrose 36/96 (38%) vs placebo 34/87 (39%), relative risk 0.96, 95% CI 0.66 to 1.34, p=0.83). Secondary outcomes were also similar, except children randomised to dextrose had worse visual processing scores (mean (SD) 94.5 (15.9) vs 99.8 (15.9), p=0.02) but no differences in the proportion with visual processing scores <85 or other visual test scores. Children randomised to dextrose gel were taller (z-scores 0.18 (0.97) vs −0.17 (1.01), p=0.001) and heavier (0.57 (1.07) vs 0.29 (0.92), p=0.01).

    Conclusions Treatment of neonatal hypoglycaemia (<2.6 mol/L) with dextrose gel does not alter neurosensory impairment at 4.5 years. However, further assessment of visual processing and growth may be warranted.

    Trial registration number ACTRN1260800062392.

    • neurodevelopment
    • neonatology
    • endocrinology

    Data availability statement

    Data are available on reasonable request. Data and associated documentation are available to other users under the data sharing arrangements provided by the Maternal and Perinatal Research Hub, based at the Liggins Institute, University of Auckland (https wiki.auckland.ac.nz/researchhub). The data dictionary and metadata will be published on the University of Auckland’s data repository Figshare, which allocates a DOI and thus makes these details searchable and available indefinitely. Researchers are able to use this information and the provided contact address (researchhub@auckland.ac.nz) to request a de-identified dataset through the Data Access Committee of the Liggins Institute. Data will be shared with researchers who provide a methodologically sound proposal and have appropriate ethical approval, where necessary, to achieve the research aims in the approved proposal. Data requestors are required to sign a Data Access Agreement that includes a commitment to using the data only for the specified proposal, not to attempt to identify any individual participant, a commitment to secure storage and use of the data and to destroy or return the data after completion of the project. The Liggins Institute reserves the right to charge a fee to cover the costs of making data available, if needed, for data requests that require additional work to prepare.

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    Data availability statement

    Data are available on reasonable request. Data and associated documentation are available to other users under the data sharing arrangements provided by the Maternal and Perinatal Research Hub, based at the Liggins Institute, University of Auckland (https wiki.auckland.ac.nz/researchhub). The data dictionary and metadata will be published on the University of Auckland’s data repository Figshare, which allocates a DOI and thus makes these details searchable and available indefinitely. Researchers are able to use this information and the provided contact address (researchhub@auckland.ac.nz) to request a de-identified dataset through the Data Access Committee of the Liggins Institute. Data will be shared with researchers who provide a methodologically sound proposal and have appropriate ethical approval, where necessary, to achieve the research aims in the approved proposal. Data requestors are required to sign a Data Access Agreement that includes a commitment to using the data only for the specified proposal, not to attempt to identify any individual participant, a commitment to secure storage and use of the data and to destroy or return the data after completion of the project. The Liggins Institute reserves the right to charge a fee to cover the costs of making data available, if needed, for data requests that require additional work to prepare.

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    Footnotes

    • Twitter @DeborahHarrisNP

    • Collaborators CHYLD Study Group: Steering Committee—University of Auckland (Auckland, New Zealand): Jane Harding DPhil, (chair), Jane M Alsweiler PhD, Trecia A Wouldes PhD, Gavin T L Brown PhD, Christopher J D McKinlay; University of Waterloo (Ontario, Canada): Benjamin Thompson PhD; University of Canterbury (Christchurch, New Zealand): J. Geoffrey Chase PhD; Victoria University of Wellington (Wellington New Zealand): Deborah L Harris, PhD.Data collection: Judith Ansell (PhD),1 Anne Jaquiery (PhD),1 Kelly Jones (PhD),1 Sapphire Martin (BNurs),1 Christina McQuoid (DipEdPsych),1 Jenny Rogers,1 Heather Stewart,1 Anna Timmings (MBChB),2 Anna Tottman (MBBS),1 Kate Williamson (MBBS),1 Arun Nair (MD),2 Alexandra Wallace (PhD),2 Phil Weston (MBChB),2 Nicola Austin (DM),4 Jeremy Armishaw (MBChB),5 Nicola Webster (MBBS),6 Ross Haslam (MBBS),7 Pat Ashwood (BSc),7 Lex Doyle (MD),8 Kate Callanan,8 Ian Wright (MBChB)9. Study coordination: Jessica Brosnahan (MHSc),1 Ellen Campbell (PhD),1 Coila Bevan (BA),1 Tineke Crawford,1 Kelly Fredell (BNurs),1 Kate Sommers.1Data management: Greg D Gamble (MSc),1 Claire Hahnhaussen (BSc),1 Safayet Hossin (MSc),1 Karen Frost (BSc),1 Grace McKnight,1 Janine Paynter (PhD),1 Jess Wilson (MSc),1 Rebecca Young (BEd),1 Anna Gsell (PhD),1 Aaron Le Compte (PhD),3 Matthew Signal (PhD)3 Yannah Jiang (PhD),1 Tzu-Ying (Sandy) Yu PhD,1.

      1Liggins Institute, University of Auckland, Auckland, New Zealand. 2Waikato Hospital, Hamilton, New Zealand. 3University of Canterbury, Christchurch, New Zealand. 4Canterbury District Health Board, Christchurch, New Zealand. 5Bay of Plenty District Health Board, Tauranga, New Zealand. 6Mid-Central District Health Board, Palmerston North, New Zealand. 7Women’s and Children’s Hospital, Adelaide, Australia. 8Royal Women’s Hospital, Melbourne, Australia. 9John Hunter Children’s Hospital, Newcastle, Australia.

    • Contributors DLH contributed to the study design, data collection and interpretation, drafted the initial manuscript and subsequent revisions of the manuscript. GDG contributed to the study design, data analysis and interpretation and revision of the manuscripts. JEH contributed to the study design, data interpretation and revision of manuscripts, in addition to taking responsibility for the overall content as guarantor. All authors approved the final manuscript and agreed to be accountable for all aspects of the work.

    • Funding The Sugar Babies Study was funded by the Waikato Medical Research Foundation, the Auckland Medical Research Foundation, the Maurice and Phyllis Paykel Trust, the Health Research Council of New Zealand and the Rebecca Roberts Scholarship. Follow-up was funded by the Health Research Council of New Zealand and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health under award number R01HD0692201.

    • Competing interests None declared.

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