The safety and efficacy of growth hormone treatment in children born small for gestational age

Completed

• Conditions: Disease: All Diseases; Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Pregnancy and Childbirth; Slow fetal growth and fetal malnutrition

• Registration Number: ISRCTN36828561
• Lead Sponsor: Rigshospitalet (Denmark)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Small for gestational age (body weight [BW] less than -2 SD according to country specific references)
2. Gestational age at birth more than 28 weeks
3. Short at 4 years of age (Height SDS less than -2.5 according to country specific references)
4. Short for parental height (HSDS greater than 1 SD below parental adjusted HSDS (mid parental height SDS)
5. Age 4 - 8.99 years (girls) and 4 - 9.99 years (boys)
6. Prepubertal at start of treatment (largest testis volume less than 4 ml, breast stage 1)
7. Height records must be available for 6 months prior to inclusion into the study
8. Height velocity SDS less than 0 during last 6 months (according to country specific references)
9. Subjects must be naïve to growth hormone therapy

Exclusion Criteria

1. Known or suspected allergy to growth hormone
2. Previous participation in growth hormone trial
3. Severe mental retardation as judged by the investigator
4. Previous or active malignancy
5. Benign intracranial hypertension (present or past)
6. Diabetes
7. Growth retardation due to chronic diseases, syndromes (like FAS) and chromosomal anomalies (except for Silver Russell syndrome)
8. Psychological problems likely to lead to significant non-compliance

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Height gain (HSDS) (3 yrs), measured when study participants reach final height; this has been taken to be 16 years of age at the latest some participants will reach final height before that age.

Secondary Outcome Measures

Name	Time	Method
1. Insulin resistance (IVGTT)<br>2. IGF-related parameters <br>3. Genetic polymorphisms in the population<br><br>Measured when study participants reach final height; this has been taken to be 16 years of age at the latest some participants will reach final height before that age.