Brain development after prenatal growth retardation; effects of growth hormone treatment
- Conditions
- small for gestational age / intra uterine growth failure1002111210010273
- Registration Number
- NL-OMON30243
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 110
Indications for GH treatment is based on the protocol as described by the dutch Working group on Growth Hormone
inclusioncriteria for group A (SGA-short; without GH treatment):
- Birth weight or birth length below *2 SD adjusted for duration of pregnancy.
- Present height below *2.5 SD and below minus 1 SD target height-SDS.
- Calendar age between 4 and 6 years.
- No evidence of catch up growth during the preceding year.
- Children are under regular control by pediatrician, but do not choose to be treated with GH ;Inclusion criteria group B: (SGA-short; with GH treatment)
This is a patient population who meet the criteria for SGA-short, (see inclusion criteria group a) and are willing to be treated with GH. ;Inclusion criteria group C (SGA-normal height):
- Birth weight or birth length below *2 SD adjusted for duration of pregnancy.
- Present height above -2.0 SD and above minus 1 SD of target height -SDS.
- Calendar age between 4 and 6 years.;Inclusion criteria group D ( AGA-normal height):
- Normal birth weight/length adjusted for duration of pregnancy
- Present height above *2 SD for age and within target range (TH plus and minus 2 SD)
- Calendar age between 4 and 6 years.;inclusion criteria for group E (SGA-short; with GH treatment):
- Birth weight or birth length below *2 SD adjusted for duration of pregnancy.
- Present height below *2.5 SD and less than 1 SD below target height-SDS.
- Calendar age above 6 years.
- No evidence of catch up growth during the preceding year.
- Children are under regular control by pediatrician, are willing to be treated with GH
Dysmorphic criteria or a known syndrome (except for Silver Russell syndrome)
Skeletal dysplasia
Serious complications in the neonatal period
Other diseases, responsible for growth failure
Medication influencing growth
Psychomotor retardation
Prematurity < 35 weeks
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>growth and brain functioning (results of neuropsychologic tests and<br /><br>neuroimaging)</p><br>
- Secondary Outcome Measures
Name Time Method <p>relationship between results of neuropsychologic tests and results of<br /><br>neuroimaging techniques</p><br>