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

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ClinicalTrials.gov Identifier: NCT02326610
Recruitment Status : Unknown
Verified December 2014 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 29, 2014
Last Update Posted : December 29, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infant, Small for Gestational Age Growth Hormone Treatment Infant, Premature, Diseases Drug: Human growth hormone,ZOMACTON® (somatropin) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early hGH Treatment of Symmetrically Born Small for Gestational Age Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae
Study Start Date : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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.

Primary Outcome Measures :
  1. 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)

  2. Changes in Neurological status (formal neurological examination) [ Time Frame: Before treatment and 1 year later ]
    using formal neurological examination

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326610

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Contact: Dror Mandel, MD +97236925690 drorm@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Principal Investigator: Dror Mandel, MD Department of Neonatology, Tel Aviv Medical Center, 64239 Tel Aviv, Israel
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02326610    
Other Study ID Numbers: TASMC-14-DM-0713-12-TLV
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: December 29, 2014
Last Verified: December 2014
Keywords provided by Tel-Aviv Sourasky Medical Center:
Small for gestational age (SGA)
Human growth hormone (hGH)
Additional relevant MeSH terms:
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Infant, Premature, Diseases
Infant, Newborn, Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs