Postnatal determinants of metabolic health during the critical window for later obesity - Sophia Pluto Study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 1,200 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•- Healthy and full-term infants (gestational age >=37)
•- Children with a neonatal period without severe asphyxia (defined as a 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.Inclusion criteria follow-up Sophia
•Pluto Study:
•- participation in the Sophia Pluto Study during the first two years of life,
•even if one or more visit(s) were not completed
•- written informed consent from both parentsegeven

•- 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 known to
•affect intra-uterine growth as per investigator*s clinical judgment.
•- Incapability of the parents to comply with 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 judgement.

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