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

Investigator initiated0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•Inclusion criteria parents:
•- Capability of the parents to comply with study protocol.
•- Knowledge of the Dutch language.
•Inclusion criteria newborns:
•- Healthy and full-term infants (gestational age = 36 weeks).
•- 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.

•Exclusion criteria parents:
•- 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.
•Exclusion criteria newborns:
•- 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.

发起方

Investigator initiated