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Clinical Trials/NL-OMON24733
NL-OMON24733
Recruiting
Not Applicable

Efficacy and safety of growth hormone treatment in short children born small for gestational age (IUGR-3 STUDY); Effects of GH-levels on growth, insulin sensitivity and body composition.

Erasmus Medical Center/ Sophia Children's HospitalPO Box 20603000 CB RotterdamThe NetherlandsTel: +31 10 463 63 630 sites157 target enrollmentTBD
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ConditionsSmall for Gestational Age (SGA), Kinderen met persisterend korte gestalte

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Small for Gestational Age (SGA), Kinderen met persisterend korte gestalte
Sponsor
Erasmus Medical Center/ Sophia Children's HospitalPO Box 20603000 CB RotterdamThe NetherlandsTel: +31 10 463 63 63
Enrollment
157
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

van Dijk M, Mulder P, Houdijk M, et al. High Serum Levels of Growth Hormone (GH) and IGF-I during High Dose Growth Hormone Treatment in Short Children Born Small for Gestational Age. J Clin Endocrinol Metab 2006

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Erasmus Medical Center/ Sophia Children's HospitalPO Box 20603000 CB RotterdamThe NetherlandsTel: +31 10 463 63 63

Eligibility Criteria

Inclusion Criteria

  • •1\. Children born with a birth length and/or weight \< \- 2 SD for gestational age (Usher McLean (22\));
  • •2\. Neonatal period without signs of severe asphyxia (defined as Apgar score \< 3 after 5 minutes), and no serious diseases such as long\-term artificial ventilation and oxygen supply, broncho pulmonary dysplasia or other chronic lung disease;
  • •3\. Short stature defined as a height SD score below –2\.5 according to the Dutch National Growth References of 1997;
  • •4\. Height velocity (cm/year) for chronological age £ P50 (25\);
  • •5\. Chronological age at start of treatment: 3\.00 \- 7\.99 years (boys and girls);
  • •6\. Prepubertal signs defined as Tanner stage 1 or testicular volume \< 4 ml (26\);
  • •7\. Well documented growth data from birth up to 2 years and at least 1 year before the start of the study;
  • •8\. Both growth hormone deficient and growth hormone insufficient patients;
  • •9\. Informed consent.

Exclusion Criteria

  • •1\. Chromosomal disorders, known syndromes and serious dysmorphic symptoms suggestive for a syndrome that has not yet been described, except for Silver Russell Syndrome;
  • •2\. Coeliac disease and other chronic or serious diseases of the gastrointestinal tract, heart, genito\-urinary tract, liver, lungs, skeleton or central nervous system, metabolic disease or chronic or recurrent major infectious diseases, nutritional and/or vitamin deficiencies;
  • •3\. Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism, or inborn errors of metabolism, except of GHD;
  • •4\. Use of medications or interventions at this moment or during the previous 6 months that might have interfered with growth, such as corticosteroids (including high dose of corticosteroid inhalation), sex steroids, growth hormone, or major surgery (particularly of the spine or extremities);
  • •5\. Active malignancy or increased risk of leukaemia;
  • •6\. Serious suspicion of psychosocial dwarfism (emotional deprivation);
  • •7\. Expected non\-compliance.

Outcomes

Primary Outcomes

Not specified

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