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

French National Longitudinal Prospective Follow-up of Children Born Small for Gestational Age and Treated With Norditropin SimpleXx (French Health Authorities Commitment)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01578135

Enrollment

291

Registered

2012-04-16

Start date

2007-03-18

Completion date

2018-10-09

Last updated

2022-10-20

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

Conditions

Growth Disorder, Small for Gestational Age

Brief summary

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)

Interventions

DRUGsomatropin

Patients are to fill in a questionnaire at inclusion in registry

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Born small for gestational age

Design outcomes

Primary

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

Secondary

Measure	Time frame
Blood pressure: Systolic and diastolic	6 months after inclusion into registry and then annually until adult height is reached
Bone age	6 months after inclusion into registry and then annually until adult height is reached
Insulin-Like Growth Factor 1 (IGF-1)	6 months after inclusion into registry and then annually until adult height is reached

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026