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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 2

Conditions: Infant, Premature, Diseases; Growth Hormone Treatment; Infant, Small for Gestational Age

Treatments: Drug: Human growth hormone,ZOMACTON® (somatropin)

Study type: Interventional

Funder types: Other

Identifiers

NCT02326610

TASMC-14-DM-0713-12-TLV

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 12 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

hGH, ZOMACTON® (somatropin)

Active Comparator group

Description:

For infants in the treatment group receiving ZOMACTON® (somatropin) growth hormone by injection

Treatment:

Drug: Human growth hormone,ZOMACTON® (somatropin)

No human growth hormone

No Intervention group

Description:

No growth hormone is given.