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 in | Archives of disease in childhood. Fetal and neonatal edition Vol. 108; no. 2; pp. 121 - 128 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
01.03.2023
BMJ Publishing Group LTD |
| Subjects | |
| Online Access | Get full text |
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| Abstract | 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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| AbstractList | Dextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown.
Follow-up of participants in a randomised trial recruited in a tertiary centre and assessed in a research clinic.
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.
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.
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).
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).
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.
ACTRN1260800062392. 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. 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. Dextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown.OBJECTIVEDextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown.Follow-up of participants in a randomised trial recruited in a tertiary centre and assessed in a research clinic.DESIGN AND SETTINGFollow-up of participants in a randomised trial recruited in a tertiary centre and assessed in a research clinic.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.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.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.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.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).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).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).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).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.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.ACTRN1260800062392.TRIAL REGISTRATION NUMBERACTRN1260800062392. |
| Author | Rogers, Jenny Wallace, Alexandra Gsell, Anna Webster, Nicola McKnight, Grace Crawford, Tineke Brown, Gavin T L Haslam, Ross Bevan, Coila Martin, Sapphire Stewart, Heather Yu, Tzu-Ying (Sandy) Wouldes, Trecia A Armishaw, Jeremy McQuoid, Christina Wright, Ian Jaquiery, Anne Signal, Matthew Weston, Phil Hossin, Safayet Thompson, Benjamin Paynter, Janine Alsweiler, Jane M Frost, Karen Geoffrey Chase, J Harris, Deborah L Tottman, Anna Williamson, Kate Doyle, Lex Ansell, Judith Harding, Jane McKinlay, Christopher J D Campbell, Ellen Gamble, Greg D Jones, Kelly Compte, Aaron Le Callanan, Kate Fredell, Kelly Sommers, Kate Timmings, Anna Harding, Jane E Brosnahan, Jessica Hahnhaussen, Claire Wilson, Jess Austin, Nicola Nair, Arun Young, Rebecca Jiang, Yannah Ashwood, Pat |
| AuthorAffiliation | c Liggins Institute, University of Auckland, Auckland, New Zealand b Newborn Intensive Care Unit, Waikato District Health Board, Hamilton, New Zealand a School of Nursing, Midwifery and Health Practice, Faculty of Health, Victoria University of Wellington, New Zealand |
| AuthorAffiliation_xml | – name: b Newborn Intensive Care Unit, Waikato District Health Board, Hamilton, New Zealand – name: a School of Nursing, Midwifery and Health Practice, Faculty of Health, Victoria University of Wellington, New Zealand – name: c Liggins Institute, University of Auckland, Auckland, New Zealand |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/35940872$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_3389_fped_2022_1048897 crossref_primary_10_1136_bmjmed_2023_000544 |
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| ContentType | Journal Article |
| Contributor | Yu, Tzu-Ying Sandy Rogers, Jenny Paynter, Janine Alsweiler, Jane M Frost, Karen Geoffrey Chase, J Wallace, Alexandra Gsell, Anna Harris, Deborah L Tottman, Anna Webster, Nicola Williamson, Kate Doyle, Lex Ansell, Judith McKnight, Grace Harding, Jane Crawford, Tineke Brown, Gavin T L McKinlay, Christopher J D Haslam, Ross Bevan, Coila Martin, Sapphire Campbell, Ellen Stewart, Heather Gamble, Greg D Jones, Kelly Compte, Aaron Le Callanan, Kate Wouldes, Trecia A Armishaw, Jeremy Fredell, Kelly McQuoid, Christina Wright, Ian Sommers, Kate Timmings, Anna Brosnahan, Jessica Hahnhaussen, Claire Jaquiery, Anne Wilson, Jess Austin, Nicola Signal, Matthew Weston, Phil Hossin, Safayet Thompson, Benjamin Nair, Arun Young, Rebecca Jiang, Yannah Ashwood, Pat |
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| Copyright | Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ. 2023 Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ. |
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| DOI | 10.1136/archdischild-2022-324148 |
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| Keywords | neurodevelopment neonatology endocrinology |
| Language | English |
| License | Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ. |
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| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 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. |
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| PublicationTitle | Archives of disease in childhood. Fetal and neonatal edition |
| PublicationTitleAbbrev | Arch Dis Child Fetal Neonatal Ed |
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| References | De Angelis, Brigati, Polleri (R28) 2021; 12 Rozance, Wolfsdorf (R14) 2019; 66 Goodman (R24) 1997; 38 Thornton, Stanley, De Leon (R3) 2015; 167 Taylor, Joseph, Kuban (R31) 2021; 147 Ong, Preece, Emmett (R30) 2002; 52 Rawat, Chandrasekharan, Turkovich (R7) 2016; 1 Narvey, Marks (R12) 2019; 24 Bennett, Headtke, Rowe‐Telow (R6) 2015; 44 Nolan, Bond, Adler (R25) 1996; 32 Hawdon (R11) 2019; 35 Harding, Harris, Hegarty (R29) 2017; 104 Harris, Alsweiler, Ansell (R16) 2016; 170 Adamkin (R2) 2011; 127 Shah, Harding, Brown (R1) 2019; 115 Weston, Harris, Harding (R5) 2017; 102 Ter, Halibullah, Leung (R8) 2017; 53 Glasgow, Harding, Edlin (R9) 2018; 198 Harris, Weston, Signal (R4) 2013; 382 McKinlay, Alsweiler, Anstice (R17) 2017; 171 Wackernagel, Gustafsson, Edstedt Bonamy (R13) 2020; 109 2024031508100897000_108.2.121.29 2024031508100897000_108.2.121.21 2024031508100897000_108.2.121.20 2024031508100897000_108.2.121.23 2024031508100897000_108.2.121.22 2024031508100897000_108.2.121.25 2024031508100897000_108.2.121.24 2024031508100897000_108.2.121.27 2024031508100897000_108.2.121.26 Glasgow (2024031508100897000_108.2.121.9) 2018; 198 2024031508100897000_108.2.121.4 2024031508100897000_108.2.121.5 2024031508100897000_108.2.121.2 Bennett (2024031508100897000_108.2.121.6) 2015; 44 2024031508100897000_108.2.121.3 Rawat (2024031508100897000_108.2.121.7) 2016; 1 McKinlay (2024031508100897000_108.2.121.17) 2017; 171 De Angelis (2024031508100897000_108.2.121.28) 2021; 12 2024031508100897000_108.2.121.18 2024031508100897000_108.2.121.19 Ter (2024031508100897000_108.2.121.8) 2017; 53 2024031508100897000_108.2.121.1 Wackernagel (2024031508100897000_108.2.121.13) 2020; 109 2024031508100897000_108.2.121.10 2024031508100897000_108.2.121.31 2024031508100897000_108.2.121.12 2024031508100897000_108.2.121.14 2024031508100897000_108.2.121.16 2024031508100897000_108.2.121.15 Hawdon (2024031508100897000_108.2.121.11) 2019; 35 2024031508100897000_108.2.121.30 |
| References_xml | – volume: 171 start-page: 972 year: 2017 ident: R17 article-title: Association of neonatal glycemia with neurodevelopmental outcomes at 4.5 years publication-title: JAMA Pediatr doi: 10.1001/jamapediatrics.2017.1579 contributor: fullname: Anstice – volume: 52 start-page: 863 year: 2002 ident: R30 article-title: Size at birth and early childhood growth in relation to maternal smoking, parity and infant breast-feeding: longitudinal birth cohort study and analysis publication-title: Pediatr Res doi: 10.1203/00006450-200212000-00009 contributor: fullname: Emmett – volume: 147 year: 2021 ident: R31 article-title: Changes in neurodevelopmental outcomes from age 2 to 10 years for children born extremely preterm publication-title: Pediatrics doi: 10.1542/peds.2020-001040 contributor: fullname: Kuban – volume: 198 start-page: 151 year: 2018 ident: R9 article-title: Cost analysis of treating neonatal hypoglycemia with dextrose gel publication-title: J Pediatr doi: 10.1016/j.jpeds.2018.02.036 contributor: fullname: Edlin – volume: 44 start-page: S52 year: 2015 ident: R6 article-title: Use of dextrose gel reverses neonatal hypoglycemia and decreases admissions to the NICU publication-title: J Obstet Gynecol Neonatal Nurs doi: 10.1111/1552-6909.12614 contributor: fullname: Rowe‐Telow – volume: 170 start-page: 54 year: 2016 ident: R16 article-title: Outcome at 2 years after dextrose gel treatment for neonatal hypoglycemia: follow-up of a randomized trial publication-title: J Pediatr doi: 10.1016/j.jpeds.2015.10.066 contributor: fullname: Ansell – volume: 53 start-page: 408 year: 2017 ident: R8 article-title: Implementation of dextrose gel in the management of neonatal hypoglycaemia publication-title: J Paediatr Child Health doi: 10.1111/jpc.13409 contributor: fullname: Leung – volume: 35 start-page: 521 year: 2019 ident: R11 article-title: Identification and management of neonatal hypoglycemia in the full-term infant. 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infant. 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| Snippet | ObjectiveDextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown.Design and settingFollow-up of participants in a randomised trial... Dextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown. Follow-up of participants in a randomised trial recruited in a tertiary... Objective Dextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown. Design and setting Follow-up of participants in a randomised... Dextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown.OBJECTIVEDextrose gel is used to treat neonatal hypoglycaemia, but later... |
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| SubjectTerms | Age Binomial distribution Blood Glucose Cerebral palsy Child Child, Preschool Children & youth Cognitive ability endocrinology Executive function Follow-Up Studies Glucose Hearing loss Humans Hypoglycemia Hypoglycemia - chemically induced Hypoglycemia - complications Hypoglycemia - drug therapy Infant Infant, Newborn Infant, Newborn, Diseases - drug therapy Mothers neonatology neurodevelopment Original research Parents & parenting Pediatrics Questionnaires Sugar Sugars - therapeutic use |
| Title | Outcome at 4.5 years after dextrose gel treatment of hypoglycaemia: follow-up of the Sugar Babies randomised trial |
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