Postnatal determinants of metabolic health during the critical window for later obesity
- Conditions
- obesityoverweight1001842410003018
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1200
- 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are body composition, anthropometric measurements and<br /><br>metabolic health parameters in serum( e.g. serum lipids, satiety hormones),<br /><br>saliva (satiety hormones) and stool.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>