TY - JOUR
T1 - Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia
T2 - Follow-Up of a Randomized Trial
AU - Harris, Deborah L
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.
KW - Adult
KW - Australia
KW - Blood Glucose/drug effects
KW - Child Development
KW - Child, Preschool
KW - Developmental Disabilities/drug therapy
KW - Female
KW - Follow-Up Studies
KW - Gels
KW - Glucose/administration & dosage
KW - Humans
KW - Hypoglycemia/complications
KW - Infant
KW - Infant, Newborn
KW - Infant, Newborn, Diseases/drug therapy
KW - Male
KW - New Zealand
KW - Sweetening Agents/administration & dosage
UR - http://www.scopus.com/inward/record.url?scp=84960079364&partnerID=8YFLogxK
UR - http://www.mendeley.com/research/outcome-2-years-after-dextrose-gel-treatment-neonatal-hypoglycemia-followup-randomized-trial
U2 - 10.1016/j.jpeds.2015.10.066
DO - 10.1016/j.jpeds.2015.10.066
M3 - Article
C2 - 26613985
SN - 0022-3476
VL - 170
SP - 54-59.e2
JO - Journal of Pediatrics
JF - Journal of Pediatrics
ER -