Title: NESGAS North European Small for Gestational Age Study version 2 01062005
1NESGASNorth 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
2INCLUSION 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.