Clinical trial: Validation of Two Measures for Growth Hormone Deficiency in Children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD) (NCT02580032)

Eligibility criteria:
Inclusion Criteria:

          -  Informed consent obtained

          -  Child population - treatment näive:

          -  Confirmed diagnosis of Growth Hormone Deficiency (GHD) prior to enrolment as
             determined by a Growth Hormone (GH) stimulation test, defined as a peak GH level of
             7.0 ng/ml or less. The GH stimulation test will be according to local clinical
             standards

          -  Pre pubertal children age 9 to less than 13 years at enrolment

          -  No prior exposure to GH therapy (GH-treatment naïve)

          -  Annualized height velocity (HV) below the 25th percentile for Chronological Age (CA)
             (HV less than -0.7 SD scores) and sex according to the standards of Prader et al
             (1989)

          -  Body Mass Index (BMI) percentile greater than 5th and below 95th percentile according
             to Centers for Disease Control and Prevention (CDC) BMI-for-age growth charts

          -  Child population - maintenance patients:

          -  Confirmed diagnosis of GHD prior to enrolment as determined by a GH stimulation test,
             defined as a peak GH level of 10.0 ng/ml or less. The GH stimulation test will be
             according to local clinical standards

          -  Pre pubertal children age 9 to less than 13 years at enrolment

          -  Body Mass Index (BMI) percentile greater than 5th and below 95th percentile according
             to Centers for Disease Control and Prevention (CDC) BMI-for-age growth charts

          -  Parent/Guardian population - treatment näive:

          -  Parent/Guardian of child with a confirmed diagnosis of GHD prior to enrolment as
             determined by a GH stimulation test, defined as a peak GH level of 7.0 ng/ml or less.
             The GH stimulation test will be according to local clinical standards

          -  Parent/Guardian of pre pubertal child age 4 to less than 9 years at enrolment

          -  Parent/Guardian of child with no prior exposure to GH therapy (GH-treatment naïve)

          -  Parent/Guardian of child with annualized height velocity (HV) below the 25th
             percentile for CA (HV less than -0.7 SD scores) and sex according to the standards of
             Prader et al (1989)

          -  Parent/Guardian of child with Body Mass Index (BMI) percentile greater than 5th and
             below 95th percentile according to Centers for Disease Control and Prevention (CDC)
             BMI-for-age growth charts

          -  Parent/Guardian living in the same residence as the child at least 50% of the time

          -  Parent/Guardian population - maintenance patients:

          -  Parent/Guardian of child with confirmed diagnosis of GHD prior to enrolment as
             determined by a GH stimulation test, defined as a peak GH level of 10.0 ng/ml or less.
             The GH stimulation test will be according to local clinical standards

          -  Parent/Guardian of pre pubertal child age 4 to less than 9 years at enrolment

          -  Parent/Guardian of child with Body Mass Index (BMI) percentile greater than 5th and
             below 95th percentile according to Centers for Disease Control and Prevention (CDC)
             BMI-for-age growth charts

          -  Parent/Guardian living in the same residence as the child at least 50% of the time
             Exclusion Criteria:

          -  Child population - treatment näive and maintenance patients:

          -  Any clinically significant abnormality likely to affect growth or the ability to
             evaluate growth:

          -  a) Chromosomal abnormalities and medical "syndromes", e.g. but not limited to Turner's
             syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors

          -  b) Congenital abnormalities (causing skeletal abnormalities), e.g. but not limited to
             Russell-Silver Syndrome, skeletal dysplasia's

          -  c) Significant spinal abnormalities including scoliosis, kyphosis and spina bifida
             variants - Children born small for gestational age (SGA - birth weight and/or birth
             length less than -2 SD for gestational age)

          -  Children diagnosed with diabetes mellitus or fasting blood glucose greater than or
             equal to 126 mg/dl (7.0 mmol/L), or HbA1c greater than or equal to 6.5% at enrolment

          -  Current inflammatory diseases (e.g. but not limited to arthritis, inflammatory bowel
             diseases) requiring systemic corticosteroid treatment or glucocorticoids treatment for
             longer than 2 weeks within the last 3 months prior to enrolment

          -  Children requiring glucocorticoid therapy (e.g. asthma) who are taking a dose of
             greater than 400 µg/day of inhaled budesonide or equivalents for longer than 1 month
             the year prior to enrolment

          -  Concomitant administration of other treatments that may have an effect on growth, e.g.
             but not limited to anabolic steroids and methylphenidate for attention deficit
             hyperactivity disorder (ADHD). Hormone replacement therapies (thyroxin,
             hydrocortisone, desmopressin) are allowed for inclusion

          -  Any disorder which, in the opinion of the investigator, might jeopardise subject's
             safety or compliance with the protocol

          -  The subject and/or the parent/Legally Acceptable Representative (LAR) are likely to be
             non-compliant in respect to trial conduct, as judged by the investigator

          -  Parent/Guardian population - treatment näive and maintenance patients:

          -  Parent/Guardian of child with any clinically significant abnormality likely to affect
             growth or the ability to evaluate growth:

          -  a) Chromosomal abnormalities and medical "syndromes", e.g. but not limited to Turner's
             syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors

          -  b) Congenital abnormalities (causing skeletal abnormalities), e.g. but not limited to
             Russell-Silver Syndrome, skeletal dysplasia's

          -  c) Significant spinal abnormalities including scoliosis, kyphosis and spina bifida
             variants - Parent/Guardian of child born small for gestational age (SGA - birth weight
             and/or birth length less than -2 SD for gestational age)

          -  Parent/Guardian of child diagnosed with diabetes mellitus or fasting blood glucose
             greater than or equal to 126 mg/dl (7.0 mmol/L), or HbA1c greater than or equal to
             6.5% at enrolment

          -  Parent/Guardian of child with current inflammatory diseases (e.g. but not limited to
             arthritis, inflammatory bowel diseases) requiring systemic corticosteroid treatment or
             glucocorticoids treatment for longer than 2 weeks within the last 3 months prior to
             enrolment

          -  Parent/Guardian of children requiring glucocorticoid therapy (e.g. asthma) who are
             taking a dose of greater than 400 µg/day of inhaled budesonide or equivalents for
             longer than 1 month the year prior to enrolment

          -  Parent/Guardian of child with concomitant administration of other treatments that may
             have an effect on growth, e.g. but not limited to anabolic steroids and
             methylphenidate for attention deficit hyperactivity disorder (ADHD). Hormone
             replacement therapies (thyroxin, hydrocortisone, desmopressin) are allowed for
             inclusion

          -  Parent/Guardian of child with any disorder which, in the opinion of the investigator,
             might jeopardise subject's safety or compliance with the protocol

          -  The subject and/or the parent/LAR are likely to be non-compliant in respect to trial
             conduct, as judged by the investigator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 13 Years

Patient description (medical language): A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively.  On physical examination, the patient's height is in the 5th percentile of her age.  Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus.  Chromosomal analysis reveals a 45, XO karyotype.

Patient description (patient's own words): I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype.

Does the patient match the trial criteria? Contradiction