Skip to content

The Sophia Pluto Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28413
Enrollment
1000
Registered
2019-06-26
Start date
2012-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, diabetes type II, cardiovascular diseases

Interventions

None listed

Sponsors

Investigator initiated
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactKirsten de Fluiter

Erasmus Medical Center - Sophia Childrens Hospital

k.defluiter@erasmusmc.nl+31-10-7037174

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)