An observational study in Bone Turnover Rate Disorder, sponsored by Iaso Maternity Hospital, Athens, Greece. Completed at 1 site in Greece. Open to participants aged 1 Day to 3 Days. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by Iaso Maternity Hospital, Athens, Greece · Observational
Evaluation of changes in biochemical markers of bone metabolism. Fat profile. Evaluation of the overall body development. Assessment of parenteral nutrition protocols.
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.
Iaso Maternity Hospital, Athens, Greece is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Very Low Birth Weight preterm neonates with gestational age \<32 weeks
Exclusion Criteria:
premature neonates receiving MCT/ω-3-PUFA-containing lipid emulsion
Dietary Supplement: MCT/ω-3-PUFA
premature neonates receiving Soybean Based lipid emulsion
Dietary Supplement: Soybean Based
lipid emulsion
lipid emulsion
change in plasma calcium and osteocalcin levels
Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life
Time frame: 20 days
change in plasma DHA, EPA levels
Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life
Time frame: 20 days
cange in plasma OPG levels
Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life
Time frame: 20 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Iaso Maternity Hospital, Athens, Greece