Standardized versus individualized growth hormone treatment of short children born small for gestational age: Effects on short-term and longterm efficacy, long-term psychosocial development, glucose metabolism and body composition.

Standardized versus individualized growth hormone treatment of short children born small for gestational age: Effects on short-term and longterm efficacy, long-term psychosocial development, glucose metabolism and body composition. - National SGA study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38571

Enrollment

300

Registered

2013-08-14

Start date

2014-01-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dysmaturity small for gestational age

Interventions

Patients are randomly assigned to one of the two GH dose regimens (1 mg/m2/day versus individualized dose) at the start of the study.

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: • Children born with a birth length and/or weight

Exclusion criteria

Exclusion criteria: • Syndromes (except for Silver Russell Syndrome), chromosomal abnormalities and serious dysmorphic symptoms suggestive for a syndrome that has not yet been described • Severe psychomotor retardation according to the DSM IV • Complicated neonatal period, including signs of severe asphyxia (defined as an Apgar score

Design outcomes

Primary

Measure	Time frame
Primary objectives: • To assess the effect of individualizing the growth hormone dose versus standard treatment with 1 mg/m2/day on adult height SDS. • To study whether treatment with individualizing the growth hormone dose results in comparable adult height SDS as standard treatment with 1 mg/m2/day (non-inferiorty)	—

Secondary

Measure	Time frame
Secondary objectives • To assess the effect of individualizing the growth hormone dose versus standard treatment with 1 mg/m2/day on the first and five year growth response. • To assess the long term safety of growth hormone therapy on glucose metabolism and body composition. • To determine the effect of growth hormone therapy on psychosocial and neurological development, and intelligence.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)