NL-OMON54727
Recruiting
N/A
'Study on infant Adiposity development To Understand the Role of early life Nutrition - the Sophia Saturn Study' - The Sophia Saturn Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 234
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
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 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
Outcomes
Primary Outcomes
Not specified
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