Elsevier

The Journal of Pediatrics

Volume 170, March 2016, Pages 54-59.e2
The Journal of Pediatrics

Original Article
Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial

https://doi.org/10.1016/j.jpeds.2015.10.066Get rights and content

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.

Section snippets

Methods

The Sugar Babies Study was a randomized, double-blind, placebo-controlled trial performed at a tertiary referral center (Waikato Women's Hospital) in Hamilton, New Zealand (Australian New Zealand Clinical Trials Registry: ACTRN 12608000623392) between December 1, 2008, and November 26, 2010, and has been reported previously.11 In brief, eligible babies were ≥35 weeks' gestation, <48 hours old, and at risk for neonatal hypoglycemia (infant of mothers with diabetes, late preterm [35 or 36 weeks'

Results

Of the 237 eligible babies, 184 (78%) were assessed at 2 years of age between July 21, 2010 and January 30, 2013 (Figure; available at www.jpeds.com). The characteristics of the mothers of children who were and were not followed up were similar, except for greater parity in mothers of those who were followed up (Table I). The characteristics of children who were and were not assessed at 2 years of age also were similar, as were those of assessed children who were randomized to dextrose gel and

Discussion

Dextrose gel is attractive as a primary treatment for neonatal hypoglycemia because it is simple, inexpensive, and with no adverse effects detected in the neonatal period.11 This follow-up study provides evidence that treatment with dextrose gel is not associated with adverse effects at 2 years' corrected age. These findings are consistent across assessment of a broad range of functions including neurodevelopment, executive function, vision and growth.

The major reason for treating neonatal

References (38)

  • J.M. Kerstjens et al.

    Neonatal morbidities and developmental delay in moderately preterm-born children

    Pediatrics

    (2012)
  • A. Lucas et al.

    Adverse neurodevelopmental outcome of moderate neonatal hypoglycaemia

    BMJ

    (1988)
  • E.W. Tam et al.

    Occipital lobe injury and cortical visual outcomes after neonatal hypoglycemia

    Pediatrics

    (2008)
  • E. Stenninger et al.

    Long term neurological dysfunction and neonatal hypoglycaemia after diabetic pregnancy

    Arch Dis Child Fetal Neonatal Ed

    (1988)
  • S. Wild et al.

    Global prevalence of diabetes: estimates for the year 2000 and projections for 2030

    Diabetes Care

    (2004)
  • D.L. Harris et al.

    A survey of the management of neonatal hypoglycaemia within the Australian and New Zealand Neonatal Network

    J Paediatr Child Health

    (2009)
  • M. Ter et al.

    Implementation of dextrose gel in neonatal hypoglycaemia management

    J Paediatr Child Health

    (2015)
  • N. Bayley

    Bayley scales of infant and toddler development

    (2006)
  • S.M. Carlson et al.

    Executive function and theory of mind: stability and prediction from ages 2 to 3

    Dev Psychol

    (2004)
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    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.

    List of CHYLD Study Team members is available at www.jpeds.com (Appendix).

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