Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia

Follow-Up of a Randomized Trial

Deborah L Harris, Jane M Alsweiler, Judith M Ansell, Gregory D Gamble, Benjamin Thompson, Trecia A Wouldes, Tzu-Ying Yu, Jane E Harding, Children with Hypoglycaemia and their Later Development (CHYLD) Study Team

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

OBJECTIVE: To determine neurodevelopmental outcome at 2 years' corrected age in children randomized to treatment with dextrose gel or placebo for hypoglycemia soon after birth (The Sugar Babies Study). STUDY DESIGN: This was a follow-up study of 184 children with hypoglycemia (<2.6 mM [47 mg/dL]) in the first 48 hours and randomized to either dextrose (90/118, 76%) or placebo gel (94/119, 79%). Assessments were performed at Kahikatea House, Hamilton, New Zealand, and included neurologic function and general health (pediatrician assessed), cognitive, language, behavior, and motor skills (Bayley Scales of Infant and Toddler Development, Third Edition), executive function (clinical assessment and Behaviour Rating Inventory of Executive Function-Preschool Edition), and vision (clinical examination and global motion perception). Coprimary outcomes were neurosensory impairment (cognitive, language or motor score below -1 SD or cerebral palsy or blind or deaf) and processing difficulty (executive function or global motion perception worse than 1.5 SD from the mean). Statistical tests were two sided with 5% significance level. RESULTS: Mean (± SD) birth weight was 3093 ± 803 g and mean gestation was 37.7 ± 1.6 weeks. Sixty-six children (36%) had neurosensory impairment (1 severe, 6 moderate, 59 mild) with similar rates in both groups (dextrose 38% vs placebo 34%, relative risk 1.11, 95% CI 0.75-1.63). Processing difficulty also was similar between groups (dextrose 10% vs placebo 18%, relative risk 0.52, 95% CI 0.23-1.15). CONCLUSIONS: Dextrose gel is safe for the treatment of neonatal hypoglycemia, but neurosensory impairment is common among these children.TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN 12608000623392.

Original languageEnglish
Pages (from-to)54-59.e2
Number of pages8
JournalJournal of Pediatrics
Volume170
DOIs
Publication statusPublished - Mar 2016
Externally publishedYes

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Hypoglycemia
Gels
Executive Function
Glucose
Placebos
Motion Perception
New Zealand
Language
Therapeutics
Motor Skills
Cerebral Palsy
Child Development
Birth Weight
Nervous System
Registries
Clinical Trials
Parturition
Equipment and Supplies
Pregnancy
Health

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Harris, D. L., Alsweiler, J. M., Ansell, J. M., Gamble, G. D., Thompson, B., Wouldes, T. A., ... Children with Hypoglycaemia and their Later Development (CHYLD) Study Team (2016). Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial. Journal of Pediatrics, 170, 54-59.e2. https://doi.org/10.1016/j.jpeds.2015.10.066
Harris, Deborah L ; Alsweiler, Jane M ; Ansell, Judith M ; Gamble, Gregory D ; Thompson, Benjamin ; Wouldes, Trecia A ; Yu, Tzu-Ying ; Harding, Jane E ; Children with Hypoglycaemia and their Later Development (CHYLD) Study Team. / Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia : Follow-Up of a Randomized Trial. In: Journal of Pediatrics. 2016 ; Vol. 170. pp. 54-59.e2.
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abstract = "OBJECTIVE: To determine neurodevelopmental outcome at 2 years' corrected age in children randomized to treatment with dextrose gel or placebo for hypoglycemia soon after birth (The Sugar Babies Study). STUDY DESIGN: This was a follow-up study of 184 children with hypoglycemia (<2.6 mM [47 mg/dL]) in the first 48 hours and randomized to either dextrose (90/118, 76{\%}) or placebo gel (94/119, 79{\%}). Assessments were performed at Kahikatea House, Hamilton, New Zealand, and included neurologic function and general health (pediatrician assessed), cognitive, language, behavior, and motor skills (Bayley Scales of Infant and Toddler Development, Third Edition), executive function (clinical assessment and Behaviour Rating Inventory of Executive Function-Preschool Edition), and vision (clinical examination and global motion perception). Coprimary outcomes were neurosensory impairment (cognitive, language or motor score below -1 SD or cerebral palsy or blind or deaf) and processing difficulty (executive function or global motion perception worse than 1.5 SD from the mean). Statistical tests were two sided with 5{\%} significance level. RESULTS: Mean (± SD) birth weight was 3093 ± 803 g and mean gestation was 37.7 ± 1.6 weeks. Sixty-six children (36{\%}) had neurosensory impairment (1 severe, 6 moderate, 59 mild) with similar rates in both groups (dextrose 38{\%} vs placebo 34{\%}, relative risk 1.11, 95{\%} CI 0.75-1.63). Processing difficulty also was similar between groups (dextrose 10{\%} vs placebo 18{\%}, relative risk 0.52, 95{\%} CI 0.23-1.15). CONCLUSIONS: Dextrose gel is safe for the treatment of neonatal hypoglycemia, but neurosensory impairment is common among these children.TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN 12608000623392.",
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Harris, DL, Alsweiler, JM, Ansell, JM, Gamble, GD, Thompson, B, Wouldes, TA, Yu, T-Y, Harding, JE & Children with Hypoglycaemia and their Later Development (CHYLD) Study Team 2016, 'Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial', Journal of Pediatrics, vol. 170, pp. 54-59.e2. https://doi.org/10.1016/j.jpeds.2015.10.066

Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia : Follow-Up of a Randomized Trial. / Harris, Deborah L; Alsweiler, Jane M; Ansell, Judith M; Gamble, Gregory D; Thompson, Benjamin; Wouldes, Trecia A; Yu, Tzu-Ying; Harding, Jane E; Children with Hypoglycaemia and their Later Development (CHYLD) Study Team.

In: Journal of Pediatrics, Vol. 170, 03.2016, p. 54-59.e2.

Research output: Contribution to journalArticle

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T2 - Follow-Up of a Randomized Trial

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AU - Alsweiler, Jane M

AU - Ansell, Judith M

AU - Gamble, Gregory D

AU - Thompson, Benjamin

AU - Wouldes, Trecia A

AU - Yu, Tzu-Ying

AU - Harding, Jane E

AU - Children with Hypoglycaemia and their Later Development (CHYLD) Study Team

N1 - Copyright © 2016 Elsevier Inc. All rights reserved.

PY - 2016/3

Y1 - 2016/3

N2 - OBJECTIVE: To determine neurodevelopmental outcome at 2 years' corrected age in children randomized to treatment with dextrose gel or placebo for hypoglycemia soon after birth (The Sugar Babies Study). STUDY DESIGN: This was a follow-up study of 184 children with hypoglycemia (<2.6 mM [47 mg/dL]) in the first 48 hours and randomized to either dextrose (90/118, 76%) or placebo gel (94/119, 79%). Assessments were performed at Kahikatea House, Hamilton, New Zealand, and included neurologic function and general health (pediatrician assessed), cognitive, language, behavior, and motor skills (Bayley Scales of Infant and Toddler Development, Third Edition), executive function (clinical assessment and Behaviour Rating Inventory of Executive Function-Preschool Edition), and vision (clinical examination and global motion perception). Coprimary outcomes were neurosensory impairment (cognitive, language or motor score below -1 SD or cerebral palsy or blind or deaf) and processing difficulty (executive function or global motion perception worse than 1.5 SD from the mean). Statistical tests were two sided with 5% significance level. RESULTS: Mean (± SD) birth weight was 3093 ± 803 g and mean gestation was 37.7 ± 1.6 weeks. Sixty-six children (36%) had neurosensory impairment (1 severe, 6 moderate, 59 mild) with similar rates in both groups (dextrose 38% vs placebo 34%, relative risk 1.11, 95% CI 0.75-1.63). Processing difficulty also was similar between groups (dextrose 10% vs placebo 18%, relative risk 0.52, 95% CI 0.23-1.15). CONCLUSIONS: Dextrose gel is safe for the treatment of neonatal hypoglycemia, but neurosensory impairment is common among these children.TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN 12608000623392.

AB - OBJECTIVE: To determine neurodevelopmental outcome at 2 years' corrected age in children randomized to treatment with dextrose gel or placebo for hypoglycemia soon after birth (The Sugar Babies Study). STUDY DESIGN: This was a follow-up study of 184 children with hypoglycemia (<2.6 mM [47 mg/dL]) in the first 48 hours and randomized to either dextrose (90/118, 76%) or placebo gel (94/119, 79%). Assessments were performed at Kahikatea House, Hamilton, New Zealand, and included neurologic function and general health (pediatrician assessed), cognitive, language, behavior, and motor skills (Bayley Scales of Infant and Toddler Development, Third Edition), executive function (clinical assessment and Behaviour Rating Inventory of Executive Function-Preschool Edition), and vision (clinical examination and global motion perception). Coprimary outcomes were neurosensory impairment (cognitive, language or motor score below -1 SD or cerebral palsy or blind or deaf) and processing difficulty (executive function or global motion perception worse than 1.5 SD from the mean). Statistical tests were two sided with 5% significance level. RESULTS: Mean (± SD) birth weight was 3093 ± 803 g and mean gestation was 37.7 ± 1.6 weeks. Sixty-six children (36%) had neurosensory impairment (1 severe, 6 moderate, 59 mild) with similar rates in both groups (dextrose 38% vs placebo 34%, relative risk 1.11, 95% CI 0.75-1.63). Processing difficulty also was similar between groups (dextrose 10% vs placebo 18%, relative risk 0.52, 95% CI 0.23-1.15). CONCLUSIONS: Dextrose gel is safe for the treatment of neonatal hypoglycemia, but neurosensory impairment is common among these children.TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN 12608000623392.

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