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

NCT02326610 | Unknown Phase 2

• 1 other identifier: TASMC-14-DM-0713-12-TLV
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Small for gestational age (SGA); Human growth hormone (hGH)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

hGH, ZOMACTON® (somatropin)

ACTIVE COMPARATOR

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

Drug: Human growth hormone,ZOMACTON® (somatropin)

No human growth hormone

NO INTERVENTION

No growth hormone is given.

Interventions

Human growth hormone,ZOMACTON® (somatropin) DRUG

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.

hGH, ZOMACTON® (somatropin)

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Infant, Premature, Diseases

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dror Mandel, MD

  Department of Neonatology, Tel Aviv Medical Center, 64239 Tel Aviv, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Mandel, MD

CONTACT

+97236925690; drorm@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 29, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: December 29, 2014

Record last verified: 2014-12