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The North European SGA Study

Treatment with recombinant growth hormone in children born small for gestational age (SGA) without catch-up growth


A randomized, multicenter, multinational trial to evaluate the safety and efficacy of Growth Hormone treatment at varying doses in short children born SGA

Design

An open multicenter study

Aim of study

To evaluate changes in short and long term growth, body composition and insulin sensitivity at different GH doses (low, high and IGF-I titrated dose).

Study population

300 short children born SGA aged 4-8.99 years (4-9.99 years in boys) from 7 European centres.

GH doses

Year 1

  • 67 μg Norditropin /kg bodyweight/day

Year 2 and thereafter, patients randomized to receive:

  • 35 μg Norditropin /kg bodyweight/day
  • 67 μg Norditropin /kg bodyweight/day
  • Variable dose (IGF-I titrated)

Duration of treatment

3 years

Investigations

Every 3 months:

  • Clinical exam
  • Auxology
  • IGF-I
  • IGFBP-3
  • HbA1C

At baseline, 1 yr and 3 yr:

  • IVGTT
  • DEXA scanning

At baseline and 2 yr:

  • OGTT (WHO standard)

Annually:

  • Bone age
  • Thyroid hormones
  • Lipids

Investigators

Anders Juul, Copenhagen, Denmark (principal investigator)
Olle Söder, Stockholm, Sweden
Sten Ivarsson, Malmø, Sweden
David Dunger, Cambridge, UK
Jeremy Kirk, Birmingham, UK
Malcolm Donaldson, Glasgow, Scotland
Hillary Hoey, Dublin, Ireland


If you require any help, please contact:

Anders Juul
Email: anders.juul@rh.hosp.dk

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