NL-OMON54727招募中不适用
'Study on infant Adiposity development To Understand the Role of early life Nutrition - the Sophia Saturn Study' - The Sophia Saturn Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 234
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 11（—）
入选标准
- •- Participation in the Sophia Pluto Study (MEC-2012-164)
- •- Parents have decided to start formula feeding
- •- Healthy, full-term infants (gestational age >= 37 weeks)
- •- Children with a neonatal period without severe asphyxia (defined as an Apgar
- •score < 3 after 5 minutes) and no serious disease such as long-term artificial
- •ventilation and oxygen supply, broncho pulmonary dysplasia or other lung disease
- •- Written informed consent from both parents
排除标准
- •- Maternal use of corticosteroids during pregnancy
- •- Pregnant women/parents known to have other significant medical condition
- •(including during pregnancy) that might interfere with the study or know to
- •affect intra-uterine growth as per investigator's clinical judgement
- •- Incapability of the parents to comply with the study protocol
- •- Confirmed intra-uterine infection
- •- Infants with chromosomal disorders, known syndromes and serious dismorphic
- •symptoms suggestive for a (yet unknown) syndrome
- •- Any endocrine or metabolic disorder such as diabetes mellitus, diabetes
- •insipidus, hypothyroidism or inborn errors of metabolism
- •- Infants known to have current or previous illnesses/conditions or
- •intervention which could interfere with the study, such as certain medication
- •(e.g. cortical steroids) or major surgery, as per investigator's clinical
研究者
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