Bone Turnover and Parenteral Nutrition

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

Detailed Description
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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.

Official Title
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Early Bone Turnover Markers in Relation to Parenteral Nutrition Regimens

Conditions
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Bone Turnover Rate Disorder

Intervention / Treatment
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* Dietary Supplement: MCT/ω-3-PUFA
* Dietary Supplement: Soybean Based


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smoflipid<br>premature neonates receiving MCT/ω-3-PUFA-containing lipid emulsion | Dietary Supplement: MCT/ω-3-PUFA<br>* lipid emulsion<br>|
| Intralipid<br>premature neonates receiving Soybean Based lipid emulsion | Dietary Supplement: Soybean Based<br>* lipid emulsion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in plasma calcium and osteocalcin levels | Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in plasma DHA, EPA levels | Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life | 20 days | 
| cange in plasma OPG levels | Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life | 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterms, parenteral, lipid