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A randomised controlled trial evaluating IGF1 titration in contrast to current GH dosing strategies in children born small for gestational age: the North European Small-for-Gestational-Age Study

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  • Rikke Beck Jensen
  • Ajay Thankamony
  • Susan M O'Connell
  • Jeremy Kirk
  • Malcolm Donaldson
  • Sten-A Ivarsson
  • Olle Söder
  • Edna Roche
  • Hilary Hoey
  • David B Dunger
  • Anders Juul
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BACKGROUND: Short children born small for gestational age (SGA) are treated with a GH dose based on body size, but treatment may lead to high levels of IGF1. The objective was to evaluate IGF1 titration of GH dose in contrast to current dosing strategies.

METHODS: In the North European Small-for-Gestational-Age Study (NESGAS), 92 short pre-pubertal children born SGA were randomised after 1 year of high-dose GH treatment (67 μg/kg per day) to three different regimens: high dose (67 μg/kg per day), low dose (35 μg/kg per day) or IGF1 titration.

RESULTS: The average dose during the second year of the randomised trial did not differ between the IGF1 titration group (38 μg/kg per day, s.d. 0.019) and the low-dose group (35 μg/kg per day, s.d. 0.002; P=0.46), but there was a wide variation in the IGF1 titration group (range 10-80 μg/kg per day). The IGF1 titration group had significantly lower height gain (0.17 SDS, s.d. 0.18) during the second year of the randomised trial compared with the high-dose group (0.46 SDS, s.d. 0.25), but not significantly lower than the low-dose group (0.23 SDS, s.d. 0.15; P=0.17). The IGF1 titration group had lower IGF1 levels after 2 years of the trial (mean 1.16, s.d. 1.24) compared with both the low-dose (mean 1.76, s.d. 1.48) and the high-dose (mean 2.97, s.d. 1.63) groups.

CONCLUSION: IGF1 titration of GH dose in SGA children proved less effective than current dosing strategies. IGF1 titration resulted in physiological IGF1 levels with a wide range of GH dose and a poorer growth response, which indicates the role of IGF1 resistance and highlights the heterogeneity of short SGA children.

Original languageEnglish
JournalEuropean journal of endocrinology / European Federation of Endocrine Societies
Volume171
Issue number4
Pages (from-to)509-18
Number of pages10
ISSN0804-4643
DOIs
Publication statusPublished - Oct 2014

    Research areas

  • Aging, Body Height, Child, Child, Preschool, Dose-Response Relationship, Drug, Drug Administration Schedule, Europe, Female, Human Growth Hormone, Humans, Infant, Infant, Newborn, Infant, Small for Gestational Age, Insulin-Like Growth Factor I, Male, Treatment Outcome

ID: 44860347