Early hGH Treatment of SGA Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae

Phase 2

• Conditions: Infant, Premature, Diseases; Infant, Small for Gestational Age; Growth Hormone Treatment
• Interventions: Drug: Human growth hormone,ZOMACTON® (somatropin)

• Registration Number: NCT02326610
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

SGA Infants who do not show a developmental catch-up growth within the first 6 months of life fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in partial hGH/IGF-I deficiency.

Up to 1/4 of children born SGA have neurodevelopmental deficits. The partial hGH/IGF-I deficiency in SGA children can be the major or contributory cause of to their neurodevelopmental deficits

To assess the effect of early growth hormone treatment given to symmetrical small for gestational age (SGA) infants not demonstrating catch-up growth on neurodevelopment and growth between birth and 6-12 months.

The study is an innovative research not previously performed for improving neurodevelopmental outcome of SGA infants. As this is the first study of its kind, the safety of use of GH has not been reported, however based on multiple studies assessing use of GH in infants and young children, it is reasonable to similarly expect no short and long-term adverse effects.

The study will take place at the Tel Aviv Medical Center only.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-26
• Status Verified: 2014-12
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-26
• Last Update Submitted: 2014-12-26
• Study First Posted: 2014-12-29
• Last Update Posted: 2014-12-29
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Symmetrical small for gestational age at birth: weight + length+ head circumference below -2 SD for gestational age.
• Birth weight of 1200-2200 gr
• Follow-up of growth until age of 6-12 months
• Growth parameters below -2 SD at age of 6-12 months and absence of sufficient catch-up.
• Low growth hormone levels.

Exclusion Criteria

• Chromosomal aberration
• Any congenital syndrome and any syndrome that shows a tendency to uncontrolled cell growth and to develop tumors
• Major congenital malformation (affecting growth or development)
• Congenital infection
• Exposure to teratogenic drugs or drugs affecting development during pregnancy
• Maternal drug or alcohol abuse.
• Maternal cancer as well as cancer in 1st degree relatives.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hGH, ZOMACTON® (somatropin)	Human growth hormone,ZOMACTON® (somatropin)	For infants in the treatment group receiving ZOMACTON® (somatropin) growth hormone by injection

Primary Outcome Measures

Name	Time	Method
Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III)	Before treatment and 1 year later	using the Bayley Scales of Infant Development (BSID-III)
Changes in Neurological status (formal neurological examination)	Before treatment and 1 year later	using formal neurological examination

Secondary Outcome Measures

Name	Time	Method
Changes in X-ray of the hand and wrist	Before treatment and 1 year later
Achenbach Child Behavior Checklist (CBCL)	at the end of study after 1 year of treatment
Pediatric Quality of life Inventory: the PedsQL measure	after 1 year of treatment