Efficacy on Height in SGA Children Treated With Growth Hormone

Novo Nordisk A/S151 enrolled

Overview

This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

151

Conditions

Foetal Growth Problem Small for Gestational Age

Interventions

somatropinDRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 7 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references. * Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion Exclusion Criteria: * Growth Hormone Deficiency (GHD) * Treatment with any medical product which may interfere with GH effects * Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders

Locations (37)

Outcomes

Primary Outcomes

Evaluate effect on Height in SGA Children Treated with Growth Hormone

Time frame: After 2 years of treatment

Secondary Outcomes

Appetite

Height SDS, yearly

Data from ClinicalTrials.gov

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