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

Infant, Premature, Diseases Clinical Trial

— hGH  

Official title:

Early hGH Treatment of Symmetrically Born Small for Gestational Age Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02326610
• Other study ID #: TASMC-14-DM-0713-12-TLV
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 26, 2014
• Last updated: December 26, 2014
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: December 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Dror Mandel, MD
• Phone: +97236925690
• Email: drorm[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Months

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Growth Hormone Treatment
• Infant, Premature, Diseases
• Infant, Small for Gestational Age

Intervention

Drug:
• Human growth hormone,ZOMACTON® (somatropin)
The initial dose will be 30µg/kg/day. The maximal dose will be 40µg/kg/day. The dose will be adjusted by monitoring the serum IGF-I level. Growth hormone will be delivered by injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III)	using the Bayley Scales of Infant Development (BSID-III)	Before treatment and 1 year later	No
Primary	Changes in Neurological status (formal neurological examination)	using formal neurological examination	Before treatment and 1 year later	No
Secondary	Changes in X-ray of the hand and wrist		Before treatment and 1 year later	No
Secondary	Pediatric Quality of life Inventory: the PedsQL measure		after 1 year of treatment	No
Secondary	Achenbach Child Behavior Checklist (CBCL)		at the end of study after 1 year of treatment	No