To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day
Hôpital Nord
Amiens, France
Centre Hospitalier Intercommunal d'Annemasse-Bonneville, Service de Pédiatrie et Néonatologie
Annemasse, France
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Time frame: Baseline, Month 36
Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Time frame: Baseline, Month 36
Mean Height
The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.
Time frame: Baseline, Month 12, 24, 36, 48, 60
Mean Height Standard Deviation Score (SDS) for Bone Age (BA)
The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.
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Hôpital Saint Jacques
Besançon, France
Groupe hospitalier Est- Hôpital Femme, Mère, Enfant
Bron, France
Groupe hospitalier Est-Hôpital Femme, Mère, Enfant
Bron, France
CHU d'Estaing
Clermont-Ferrand, France
CHU de Grenoble, Hôpital Couple enfant.
Grenoble, France
CHU Timone Enfants
Marseille, France
Hôpital Arnaud De Villeneuve
Montpellier, France
CHU de Nantes, Hôpital Mère Enfant
Nantes, France
...and 9 more locations
Time frame: Baseline, Month 12, 24, 36, 48, 60
Annual Growth Rate (AGR)
AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled to 1 year if the interval between Yx and Y\[x-1\] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y\[x-1\]) and height recorded at Yx (AGR Yx = \[height Yx-height Y{x-1}\] / (\[date of Yx - date of Y{x-1}\] /365.25). Yx refers to the value at particular timepoint x.
Time frame: Baseline, Month 12, 24, 36, 48, 60
Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)
GR SDS BA Yx = (GR Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand.
Time frame: Month 12, 24, 36, 48, 60
Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)
GR SDS CA Yx = (GR Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Time frame: Baseline, Month 12, 24, 36, 48, 60
Body Mass Index (BMI)
BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\^2).
Time frame: Baseline, Month 12, 24, 36, 48, 60
Change From Baseline in Height at Month 12, 24, 36, 48 and 60
The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.
Time frame: Baseline, Month 12, 24, 36, 48, 60
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60
The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Time frame: Baseline, Month 12, 24, 48, 60
Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60
The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.
Time frame: Baseline, Month 12, 24, 36, 48, 60
Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60
BA was estimated locally using an X-ray from the left wrist and hand.
Time frame: Baseline, Month 12, 24, 36, 48, 60
Ratio of Bone Age (BA) to Chronological Age (CA)
BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.
Time frame: Baseline, Month 12, 24, 36, 48, 60