Outcome at 4.5 years after dextrose gel treatment of hypoglycaemia: follow-up of the Sugar Babies randomised trial

ObjectiveDextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown.Design and settingFollow-up of participants in a randomised trial recruited in a tertiary centre and assessed in a research clinic.PatientsChildren who were hypoglycaemic (<2.6 mmol/L) recruited to the Su...

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Published inArchives of disease in childhood. Fetal and neonatal edition Vol. 108; no. 2; pp. 121 - 128
Main Authors Harris, Deborah L, Gamble, Greg D, Harding, Jane E, Harding, Jane, Alsweiler, Jane M, Wouldes, Trecia A, Brown, Gavin T L, McKinlay, Christopher J D, Thompson, Benjamin, Geoffrey Chase, J, Ansell, Judith, Jaquiery, Anne, Jones, Kelly, Martin, Sapphire, McQuoid, Christina, Rogers, Jenny, Stewart, Heather, Timmings, Anna, Tottman, Anna, Williamson, Kate, Nair, Arun, Wallace, Alexandra, Weston, Phil, Austin, Nicola, Armishaw, Jeremy, Webster, Nicola, Haslam, Ross, Ashwood, Pat, Doyle, Lex, Callanan, Kate, Wright, Ian, Brosnahan, Jessica, Campbell, Ellen, Bevan, Coila, Crawford, Tineke, Fredell, Kelly, Sommers, Kate, Hahnhaussen, Claire, Hossin, Safayet, Frost, Karen, McKnight, Grace, Paynter, Janine, Wilson, Jess, Young, Rebecca, Gsell, Anna, Compte, Aaron Le, Signal, Matthew, Jiang, Yannah, Yu, Tzu-Ying (Sandy)
Format Journal Article
LanguageEnglish
Published England BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health 01.03.2023
BMJ Publishing Group LTD
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Summary:ObjectiveDextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown.Design and settingFollow-up of participants in a randomised trial recruited in a tertiary centre and assessed in a research clinic.PatientsChildren 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.InterventionsAssessment 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 measuresNeurosensory 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).ResultsOf 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).ConclusionsTreatment 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 numberACTRN1260800062392.
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Contributors’ Statement Page
Deborah L Harris contributed to the study design, data collection and interpretation, drafted the initial manuscript and subsequent revisions of the manuscript. Greg Gamble contributed to the study design, data analysis and interpretation and revision of the manuscripts. Jane E Harding contributed to the study design, data interpretation and revision of manuscripts, in addition to taking overall responsibility for the study. All authors approved the final manuscript and agree to be accountable for all aspects of the work.
ISSN:1359-2998
1468-2052
1468-2052
DOI:10.1136/archdischild-2022-324148