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ID
Source
Brief title
Health condition
Obesity, diabetes type II, cardiovascular diseases
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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
Background summary
Evidence is rising that low birth weight for gestational age and rapid postnatal catch-up growth are risk factors for the development of obesity and diabetes type 2 in adulthood. It has been demonstrated that the early postnatal period is a critical window for the programming of various pathways in tissues and organs, in which nutrition is an important determinant. Up until now pilot data show that rapid postnatal weight gain during the first 3 months of life might cause accelerated fat accumulation which in turn will track into adulthood, but until now it remained difficult to assess infant body composition properly.
Study objective
Unfavorable exposures during the early postnatal period change programming of growth and metabolic pathways, thereby deranging infant’s body composition and increasing the risk for later obesity and diabetes type 2
Study design
1, 3, 6, 9, 12, 18 and 24 months
Kirsten de Fluiter
+31-10-7037174
k.defluiter@erasmusmc.nl
Kirsten de Fluiter
+31-10-7037174
k.defluiter@erasmusmc.nl
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 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7833 |
| Other | METC Erasmus Medical Center : MEC-2012-164 |