A Two Year Multicentre, Randomized Two Arm Study Of Genotropin Treatment In Very Young Children Born Small For Gestational Age: Early Growth And Neurodevelopment(Egn)
Overview
- Phase
- Phase 3
- Intervention
- Genotropin (PN-180,307) Somatropin
- Conditions
- Infant, Small for Gestational Age
- Sponsor
- Pfizer
- Enrollment
- 43
- Locations
- 17
- Primary Endpoint
- Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Caucasian male or female subjects aged between 19-29 months at Screening Visit
- •Born SGA (birth length and/or weight \<-2 SD for gestational age, using country-specific standards).
- •Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length between 12 and 18 months of age. Normal karyotype in girls to exclude Turners syndrome.
Exclusion Criteria
- •Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational age), if associated with dysmorphic features.
- •Severe prematurity (Gestational Age (GA) \<32 weeks of gestation). Ongoing catch-up growth (defined as growth velocity SDS at inclusion \>0) based on at least 4 months measurement interval).
- •Severe familial short stature defined as: Father's height below 155 cm or mother's height below 145 cm.
- •Defined neurological defects and/or severe neurodevelopmental delay.
Arms & Interventions
Active
The active treatment arm
Intervention: Genotropin (PN-180,307) Somatropin
Control
Control
Intervention: Control-no treatment
Outcomes
Primary Outcomes
Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.
Time Frame: Baseline and Month 24
Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
Secondary Outcomes
- Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12.(Baseline and Month 12)
- Change From Baseline in Growth Velocity SDS at Month 24.(Baseline and Month 24)
- Change From Baseline in Height SDS at Month 12.(Baseline and Month 12)
- Change From Baseline in Growth Velocity SDS at Month 12.(Baseline and Month 12)
- Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12.(Baseline and Month 12)
- Head Circumference SDS at Months 3, 6, 12, 18 and 24.(Months 3, 6, 12, 18 and 24)
- Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24.(Baseline, Months 3, 6, 12, 18 and 24.)
- Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24.(Baseline, Months 3, 6, 12, 18, and 24)
- Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24.(Baseline, Months 3, 6, 12, 18, and 24)