Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial - 25/02/16
on behalf of the
Children with Hypoglycaemia and their Later Development (CHYLD) Study Team∗
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.
Le texte complet de cet article est disponible en PDF.Keyword : Bayley-III, BRIEF-P, RR
Plan
| The Sugar Babies Study was funded by the Waikato Medical Research Foundation (171), the Auckland Medical Research Foundation (1110009), the Maurice and Phyllis Paykel Trust, the Health Research Council of New Zealand (09/095), and the Rebecca Roberts Scholarship. The Follow-up Study was funded by the Health Research Council of New Zealand (10/399) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health (R01HD0692201). The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding bodies. The authors declare no conflicts of interest. |
Vol 170
P. 54 - mars 2016 Retour au numéro
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