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Lower versus Traditional Treatment Threshold for Neonatal Hypoglycemia.

Anne A M W van Kempen1, P Frank Eskes1, Debbie H G M Nuytemans1

  • 1From OLVG, Department of Pediatrics (A.A.M.W.K., N.R.V.), and Academic Medical Center, Emma Children's Hospital, Department of Neonatology (D.H.G.M.N., J.H.K.), the University of Amsterdam, Pediatric Clinical Research Office (J.H.L.) and the VU Medical Center, Vrije Universiteit, Department of Neonatology (R.C.J.J.), Amsterdam UMC, Amsterdam, Meander Medical Center, Department of Pediatrics, Amersfoort (P.F.E.), St. Antonius Hospital, Departments of Research and Epidemiology (L.M.D.) and Pediatrics (M.D.-B), Nieuwegein, Zaans Medical Center, Department of Pediatrics, Zaandam (F.J.P.C.M.H.), Zuyderland Medical Center Heerlen, Department of Pediatrics, Sittard-Geleen (R.M.J.M.), Maastricht University Medical Center, Department of Pediatrics-Neonatology, Schools of Oncology and Developmental Biology (GROW) and NUTRIM, Maastricht (L.J.I.Z.), Erasmus MC-Sophia, Department of Neonatology (E.P.V.), Maasstad Hospital, Department of Pediatrics (H.G.S.), and St. Franciscus Gasthuis, Department of Pediatrics (M.W.A.H.), Rotterdam, Canisius-Wilhelmina Hospital, Department of Pediatrics, Nijmegen (B.A.S.), Amphia Hospital, Department of Pediatrics, Breda (R.H.T.B.), Rijnstate Hospital, Department of Pediatrics, Arnhem (J.J.V.), the University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Neonatology, Groningen (P.H.D.), University Medical Center Utrecht, Wilhelmina Children's Hospital, Department of Neonatology, Utrecht (J.U.M.T.), Albert Schweitzer Hospital, Department of Pediatrics, Dordrecht (A.C.M.), and the National Health Care Institute (ZINL), Diemen (N.B.) - all in the Netherlands; and the Hospital for Sick Children, Division of Neonatology/Child Health Evaluative Sciences, University of Toronto, Toronto (M.O.).

The New England Journal of Medicine
|February 6, 2020
PubMed
Summary

A lower glucose treatment threshold for newborns with asymptomatic moderate hypoglycemia was found to be noninferior to the traditional threshold for psychomotor development at 18 months. This study provides evidence for a revised approach to managing neonatal hypoglycemia.

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Area of Science:

  • Neonatal Medicine
  • Pediatric Endocrinology
  • Clinical Trials

Background:

  • Neonatal hypoglycemia screening is common but lacks a consensus treatment threshold.
  • Preventing brain injury in at-risk newborns is a key goal.

Purpose of the Study:

  • To compare a lower glucose treatment threshold (<36 mg/dL) with a traditional threshold (<47 mg/dL) for asymptomatic moderate hypoglycemia in newborns.
  • To determine noninferiority of the lower threshold regarding psychomotor development at 18 months.

Main Methods:

  • A multicenter randomized noninferiority trial involving 689 healthy newborns at ≥35 weeks gestation.
  • Assessed psychomotor development using the Bayley Scales of Infant and Toddler Development (Bayley-III-NL).
  • Defined noninferiority if the lower threshold group's scores were less than 7.5 points lower than the traditional group.

Main Results:

  • Cognitive and motor scores were similar between the lower-threshold (102.9±0.7 cognitive, 104.6±0.7 motor) and traditional-threshold (102.2±0.7 cognitive, 104.9±0.7 motor) groups.
  • The prespecified inferiority limit was not crossed, indicating noninferiority.
  • The lower-threshold group had fewer hypoglycemic episodes but more invasive interventions; serious adverse events were rare in both groups.

Conclusions:

  • A lower glucose treatment threshold of 36 mg/dL is noninferior to 47 mg/dL for psychomotor development in healthy newborns with asymptomatic moderate hypoglycemia.
  • This finding supports a potential revision in the management guidelines for neonatal hypoglycemia.