French National Registry of Children Born Small for Gestational Age Treated With Somatropin

Novo Nordisk A/S291 enrolled

Overview

This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)

Study Type

OBSERVATIONAL

Enrollment

291

Conditions

Growth Disorder Small for Gestational Age

Interventions

somatropinDRUG

Patients are to fill in a questionnaire at inclusion in registry

somatropinDRUG

Patients are to fill in a questionnaire 6 months after inclusion into registry and then annually until adult height is reached

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Born small for gestational age

Locations (1)

Novo Nordisk Investigational Site

Paris La Défense, France

Outcomes

Primary Outcomes

Growth in height

Time frame: 6 months after inclusion into registry and then annually until adult height is reached

Secondary Outcomes

Blood pressure: Systolic and diastolic

Time frame: 6 months after inclusion into registry and then annually until adult height is reached

Bone age

Time frame: 6 months after inclusion into registry and then annually until adult height is reached

Insulin-Like Growth Factor 1 (IGF-1)

Time frame: 6 months after inclusion into registry and then annually until adult height is reached

Data from ClinicalTrials.gov

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