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

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• 作者：Deborah L. Harris ; PhD¹ ; ² ; Jane M. Alsweiler ; FRACP ; PhD² ; Judith M. Ansell ; PhD² ; Gregory D. Gamble ; MSc² ; Benjamin Thompson ; PhD³ ; Trecia A. Wouldes ; PhD⁴ ; Tzu-Ying Yu ; PhD³ ; Jane E. Harding ; FRACP ; D Phil² ; ^{j.harding@auckland.ac.nz" class="auth_mail" title="E-mail the corresponding author} ; on behalf of the Children with Hypoglycaemia ; their Later Development (CHYLD) Study Team^&lowast ; ; Judith Ansell ; MedPsych ; PgDip ; PhD ; Coila Bevan ; BA ; Jessica Brosnanhan ; BSc ; PgDip ; Ellen Campbell ; BSc ; BA ; MSc ; Tineke Crawford ; BHSc ; PgDip ; Kelly Fredell ; BNurs ; Karen Frost ; BHSc ; Greg Gamble ; BSc ; MSc ; Anna Gsell ; PhD ; Claire Hahnhaussen ; BSc ; Safayet Hossin ; BSc ; MSc ; Yannan Jiang ; PhD ; Kelly Jones ; PgDipPsychPrac ; PhD ; Sapphire Martin ; BNurs ; Chris McKinlay ; MBChB ; DipProfEthics ; PhD ; Grace McKnight ; Christina McQuoid ; MedDip Psych ; Janine Paynter ; BHSc (Hon) ; PhD ; Jenny Rogers ; BSc ; PgDip ; Kate Sommers ; Heather Stewart ; RN ; RM ; Anna Timmings ; MBChB ; BMedSci (Hons) ; Jess Wilson ; BSc ; MSc ; Rebecca Young ; BEd ; Nicola Anstice ; BOptom ; PhD ; Jo Arthur ; BOptom ; Susanne Bruder ; BOptom ; Arijit Chakraborty ; BOptom ; Robert Jacobs ; PhD ; Gill Matheson ; BOptom ; Nabin Paudel ; BOptom ; Tzu-Ying (Sandy) Yu ; BOptom ; PhD ; Matthew Signal ; BE (Hon) ; PhD ; Aaron Le Compte ; PhD ; Max Berry ; MBBS ; PhD ; Arun Nair ; MD (Paed) DCH ; Ailsa Tuck ; MBChB ; Alexandra Wallace ; MBChB ; PhD ; Phil Weston ; MBChB ; Jane Alsweiler ; MBChB ; PhD ; Jane Harding ; MBChB ; DPhil (Chair) ; Ben Thompson ; BSc ; PhD ; Trecia Wouldes ; BA ; MA ; PhD ; J. Geoffrey Chase ; BS ; MS ; PhD ; Deborah Harris ; Dip Nursing ; MHSc (Hons) ; PhD ; Heidi Feldman ; MD ; PhD ; Darrell Wilson ; BS ; MD ; William Hay ; BA ; MD ; Robert Hess ; BSc ; MSc ; PhD ; DSc
• 关键词：Bayley-III ; Bayley Scales of Infant and Toddler Development ; Third Edition ; BRIEF-P ; Behaviour Rating Inventory of Executive Function-Preschool Edition ; RR ; Relative risk
• 刊名：The Journal of Pediatrics
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：170
• 期：Complete
• 页码：54-59.e2
• 全文大小：244 K

文摘

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.