NESGAS North European Small for Gestational Age Study version 2 01062005

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NESGASNorth European Small for Gestational Age
Study (version 2 01/06/2005)

• AIMS
• To evaluate in short children born SGA
• Different GH doses (low vs. high vs. IGF-I
  titrated dose) on
• short- term height velocity, final height
  and insulin sensitivity.
• Auxological, biochemical and genetic predictors
  of growth response and effects on insulin
  resistance following GH therapy.
• Long-term effects and safety of childhood GH
  therapy evaluated
• in adulthood (5 and 10 years after
  attaining final height).
• UK Study Population
• 100 short children born small for gestational age
  (SGA).

STUDY OUTLINE
SGA Short stature Reduced growth velocity
Inclusion / exclusion criteria assessment
BASELINE ASSESSMENT ?
Auxology ? Examination ? DXA scan ? Glucose
tolerance / insulin sensitivity test
Start Norditropin therapy (67?g/kg/day)
Randomisation after 12 months
?
Responders
Non-responders excluded
GH (67?g/kg/day)
GH (35?g/kg/day)
GH (IGF-I titrated)
Yr 23
INTERIM ANALYSIS AFTER 3 YEARS
GH (35?g/kg/day) therapy until Final Height
achieved
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INCLUSION CRITERIA
BIRTHWEIGHT (-2SD)

• Small for gestational age (BW lt -2SD)
• Gestational age at birth 28 weeks
• Short stature (Ht lt -2.5 SD or the 0.4th
  centile)
• Short for parental height (Height gt 1 SD below
  mid-parental height SDS)
• Age 4-8.99 years (girls) or 4-9.99 years (boys)
• Pre-pubertal at start of GH treatment (testes lt
  4ml breast stage 1)
• Height records must be available for 6 months
  prior to inclusion into the study
• Height velocity lt 0 SD during last 6 months
• Naïve to growth hormone therapy

For more information about this study visit the
BSPED website at www.bsped.org.uk
THIS STUDY (MREC 04/5/025) HAS BEEN APPROVED BY
THE EASTERN MULTI-CENTRE RESEARCH ETHICS
COMMITTEE.