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Nutrition in relation to the endocrine regulation of preterm growth

Postnatal modulation of body composition in preterm infants by human growth factors and hormones in relation to various nutrient compositions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27985
Enrollment
170
Registered
2015-07-20
Start date
2015-07-21
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

Preterm infants Insulin-like growth factor I Growth Body composition

Interventions

Preterm infants (born < 32 weeks) fed limited energy- and nutrient-enriched preterm follow-up formula at a postmenstrual age of 32-33 weeks will be compared to preterm infants fed according to the sta

Sponsors

VU University medical center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In October 2016 the following changes were made: - An additional reference group (n=100) of infants born between 32 and 42 weeks of gestation has been added for the analysis of endocrine parameters in cord blood; In January 2017 the following changes were made: - The intervention is stopped, because of insufficient number of formula-fed infants; - The number of participants with a gestational age less than 32 weeks was reduced from 150 to 70. Inclusion criteria: 1. Written and informed consent from either the parents or the legal guardians who at least have professional working proficiency of the Dutch, English or French language. 2. Gestational age of 24 to 32 weeks. 3. Arterial catheter in situ. In order to be eligible for cord blood analysis, a subject must meet all of the following criteria: 1. Gestational age of 24 to 42 weeks 2. Written and informed consent from either the parents or the legal guardians who at least have professional working proficiency of the Dutch, English or French language.

Exclusion criteria

Exclusion criteria: A substantial congenital anomaly based on a chromosomal or syndromal disorder with a known effect on growth and body composition.

Design outcomes

Primary

MeasureTime frame
1. Growth (height, weight, body proportions and growth pattern) 2. Body composition 3. Growth-related endocrine parameters

Secondary

MeasureTime frame
1. Psychomotor development 2. Bone mineralization 3. Lipid status 4. Blood pressure

Contacts

Public ContactDFJ Yumani

VU University Medical Center

nutriestudy@vumc.nl0031 20 4446209

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)