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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: hGH, ZOMACTON® (somatropin); For infants in the treatment group receiving ZOMACTON® (somatropin) growth hormone by injection	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.
No Intervention: No human growth hormone; No growth hormone is given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in Neurological status (formal neurological examination)	using formal neurological examination	Before treatment and 1 year later

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Dror Mandel, MD, Department of Neonatology, Tel Aviv Medical Center, 64239 Tel Aviv, Israel

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 26, 2014
• First Submitted That Met QC Criteria: December 26, 2014
• First Posted (Estimate): December 29, 2014

Study Record Updates

• Last Update Posted (Estimate): December 29, 2014
• Last Update Submitted That Met QC Criteria: December 26, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Small for gestational age (SGA); Human growth hormone (hGH)
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Infant, Premature, Diseases; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: TASMC-14-DM-0713-12-TLV