NL-OMON30243尚未招募不适用
Brain development after prenatal growth retardation; effects of growth hormone treatment - brain development after prenatal growth retardation; growth hormone
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 11(—)
入选标准
- •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
排除标准
- •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
研究者
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Brain Development after prenatal growth retardation: effects of growth hormone treatmentSmall for Gestational Age (SGA), brain developmentNutritional, Metabolic, EndocrineBrain developmentISRCTN20279720Pfizer B.V. (The Netherlands)110
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