Clinical Trial: Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome
Brief Summary: This is a randomized controlled, parallel group, open label versus "no treatment" trial which evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short bowel syndrome.The total follow-up is 14 months; 4 months for each group after randomization; At the end of the first four months: the treated group will be followed within 6 months, the untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months after the end of the treatment period.
Detailed Summary:
Sponsor: Hospices Civils de Lyon
Current Primary Outcome: Evaluate the efficacy of rhGH compared to "no treatment" on partial or total weaning off of parenteral nutrition in children with short bowel syndrome after 4 months
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation.
- To evaluate the intestinal absorption (input-output within 3 days) at the end of the randomized study (month 4) and at the end of study (month 14)
- To quantify the variation in body composition (auxology and biphotonic absorptiometry) at the end of the randomized study (month 4) and at the end of study (month 14)
- To evaluate the tolerance and safety of rhGH at the end of the randomized study (month 4) and at the end of study (month 14.
Original Secondary Outcome: Same as current
Information By: Hospices Civils de Lyon
Dates:
Date Received: September 12, 2005
Date Started: June 2006
Date Completion:
Last Updated: October 30, 2008
Last Verified: June 2008
