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Postnatal determinants of metabolic health during the critical window for later obesity

Recruiting
Conditions
obesity
overweight
10018424
10003018
Registration Number
NL-OMON54742
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
1200
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
<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
NameTimeMethod
<p>Not applicable</p><br>
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