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Brain development after prenatal growth retardation; effects of growth hormone treatment

Brain development after prenatal growth retardation; effects of growth hormone treatment - brain development after prenatal growth retardation; growth hormone

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30243
Enrollment
110
Registered
2007-04-17
Start date
2007-03-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

small for gestational age / intra uterine growth failure

Interventions

structural (only at baseline) and functional MRI*s, MEG and extensive neuropsychologic testing as described below will be performed at baseline, after one year and three years in both groups A and B

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Secondary

MeasureTime frame
relationship between results of neuropsychologic tests and results of neuroimaging techniques

Primary

MeasureTime frame
growth and brain functioning (results of neuropsychologic tests and neuroimaging)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)