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Clinical Trials/NL-OMON27985
NL-OMON27985
Completed
Not Applicable

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

VU University medical center0 sites170 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm infantsInsulin-like growth factor IGrowthBody composition
Sponsor
VU University medical center
Enrollment
170
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
VU University medical center

Eligibility 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\.
  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Not specified

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