The Sophia Pluto Study
- Conditions
- Obesity, diabetes type II, cardiovascular diseases
- Registration Number
- NL-OMON28413
- Lead Sponsor
- Investigator initiated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1000
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prenatal and postnatal growth trajectories and prenatal maternal exposures in association with body composition at ages 1, 3, 6 and 9 months with the modification of infants nutritional intake
- Secondary Outcome Measures
Name Time Method Infant’s fat mass accumulation in association with metabolic biomarkers and health parameters at the age of 3, 6, 9 months and 1 year, 18 months and 2 years, e.g. serum lipids, satiety hormones, metabolic biomarkers and body composition