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

Overview

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.

Full Title of Study: “Early hGH Treatment of Symmetrically Born Small for Gestational Age Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: hGH, ZOMACTON® (somatropin)
    • For infants in the treatment group receiving ZOMACTON® (somatropin) growth hormone by injection
  • No Intervention: No human growth hormone
    • No growth hormone is given.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 12 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tel-Aviv Sourasky Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dror Mandel, MD, Principal Investigator, Department of Neonatology, Tel Aviv Medical Center, 64239 Tel Aviv, Israel
  • Overall Contact(s)
    • Dror Mandel, MD, +97236925690, drorm@tlvmc.gov.il

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