Skip to main content
Clinical Trials/NCT03618394
NCT03618394
Completed
Not Applicable

Early Bone Turnover Markers in Relation to Parenteral Nutrition Regimens

Iaso Maternity Hospital, Athens, Greece1 site in 1 country66 target enrollmentApril 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Turnover Rate Disorder
Sponsor
Iaso Maternity Hospital, Athens, Greece
Enrollment
66
Locations
1
Primary Endpoint
change in plasma calcium and osteocalcin levels
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Evaluation of changes in biochemical markers of bone metabolism. Fat profile. Evaluation of the overall body development. Assessment of parenteral nutrition protocols.

Detailed Description

Osteopenia is very common in premature infants, particularly in preterm infants born at extremely low birth weight This is probably related to inadequate calcium and phosphorus intake, which is considerably less than the accretion of these minerals during the last trimester of pregnancy In addition, severe morbidity during the neonatal period (e.g. bronchopulmonary dysplasia \[BPD\]), chronic drug therapy (e.g. diuretics and systemic steroids), the need for total parenteral nutrition and prolonged immobility increase the risk of bone demineralization. Total parenteral nutrition is associated with osteopenia in preterm infants. Insufficient calcium and phosphate are likely causes; aluminum contamination is another possible contributing factor as this adversely affects bone formation and mineralization. The DHA+ARA-supplemented formulas supported normal growth and bone mineralization in premature infants who were born at \<33 wk gestation. Smof lipid emulsion has a high density of this fatty acids, while Intra lipid does not contain any traces of DHA. Evidence has shown that long-chain polyunsaturated fatty acids (LCPUFA), especially the ω-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are beneficial for bone health and turnover.

Registry
clinicaltrials.gov
Start Date
April 1, 2015
End Date
July 1, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Iaso Maternity Hospital, Athens, Greece
Responsible Party
Principal Investigator
Principal Investigator

Panos Papandreou

Clinical Pharmacist, PharmD

Iaso Maternity Hospital, Athens, Greece

Eligibility Criteria

Inclusion Criteria

  • gestational age \<32 weeks
  • birth weight \<1500g (VLBW infants)
  • in need of Parenteral Nutrition support

Exclusion Criteria

  • \>32 weeks of gestation
  • chromosomal or other abnormalities
  • parenteral nutrition \<80% of calorie/fluid needs
  • primary liver disease

Outcomes

Primary Outcomes

change in plasma calcium and osteocalcin levels

Time Frame: 20 days

Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life

Secondary Outcomes

  • cange in plasma OPG levels(20 days)
  • change in plasma DHA, EPA levels(20 days)

Study Sites (1)

Loading locations...

Similar Trials