Clinical trial NCT02326610: Early hGH Treatment of SGA Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae
Official title: Early hGH Treatment of Symmetrically Born Small for Gestational Age Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infant, Small for Gestational Age
Growth Hormone Treatment
Infant, Premature, Diseases
Keywords: Small for gestational age (SGA)
Human growth hormone (hGH)
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III)
timeFrame: Before treatment and 1 year later
measure: Changes in Neurological status (formal neurological examination)
timeFrame: Before treatment and 1 year later
Secondary outcomes:
measure: Changes in X-ray of the hand and wrist
timeFrame: Before treatment and 1 year later
measure: Pediatric Quality of life Inventory: the PedsQL measure
timeFrame: after 1 year of treatment
measure: Achenbach Child Behavior Checklist (CBCL)
timeFrame: at the end of study after 1 year of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neonatology, Tel Aviv Medical Center, 64239 Tel Aviv, Israel
name: Dror Mandel, MD
role: PRINCIPAL_INVESTIGATOR
References: