Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
35

Inclusion Criterias

Peak GH level after stimulation >10ng/ml
IGF-1SD score <-1SD in both males and females
Height SD score<-2.25SD in males and females
...
Peak GH level after stimulation >10ng/ml
IGF-1SD score <-1SD in both males and females
Height SD score<-2.25SD in males and females
Bone age <11 years in males and <9 years in females
ability to provide written informed consent
Prepubertal males and females form 5- 11years old

Exclusion Criterias

Treatment with inhaled or systemic steroids
BMI <5th percentile or >95th percentile
Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly
...
Treatment with inhaled or systemic steroids
BMI <5th percentile or >95th percentile
Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly
Pediatric patients with closed epiphyses
Active neoplasm
Tanner 2 at clinical or biochemical examination by ultrasensitive LH and FSH
History of prior chemotherapy and or radiation

Summary

Conditions
Short Stature
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: This study was changed to a retrospective chart review. There was no prospective component.Masking: None (Open Label)
  • Primary Purpose: Other

Participation Requirements

Age
Between 5 years and 11 years
Gender
Both males and females

Inclusion Criterias

Peak GH level after stimulation >10ng/ml
IGF-1SD score <-1SD in both males and females
Height SD score<-2.25SD in males and females
...
Peak GH level after stimulation >10ng/ml
IGF-1SD score <-1SD in both males and females
Height SD score<-2.25SD in males and females
Bone age <11 years in males and <9 years in females
ability to provide written informed consent
Prepubertal males and females form 5- 11years old

Exclusion Criterias

Treatment with inhaled or systemic steroids
BMI <5th percentile or >95th percentile
Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly
...
Treatment with inhaled or systemic steroids
BMI <5th percentile or >95th percentile
Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly
Pediatric patients with closed epiphyses
Active neoplasm
Tanner 2 at clinical or biochemical examination by ultrasensitive LH and FSH
History of prior chemotherapy and or radiation

Locations

Brooklyn, New York, 11219
Brooklyn, New York, 11219

Tracking Information

NCT #
NCT01970800
Collaborators
Not Provided
Investigators
  • Principal Investigator: Svetlana Ten, MD Maimonides Medical Center
  • Svetlana Ten, MD Maimonides Medical Center