The aim of this study will be to assess the effectiveness of monitored vit D supplementation in a population of preterm infants and to identify whether the proper vit D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.
preterm infants with a gestational age of 24+0/7 to 32+6/7 born at our clinic
preterm infants with a gestational age of 24+0/7 to 32+6/7 outborn and admitted to our intensive care unit within 48h after delivery
written informed consent form caregivers for the mother and the child to participate in the study
infants born at >32 weeks of gestation
infants with major congenital abnormalities or other severe congenital malformations
infants with genetic disorders (diagnosed before and after birth) deemed incompatible with survival
infants with diagnosed cholestasis
Parallel
cholecalciferol/ Devikap
Dietary supplementInfants in the monitored group will receive an initial dose of 1000 IU of vit D. An additional 160 IU/kg of vit D is included in parenteral nutrition, as well as 150-300 IU/kg in enteral nutrition, depending on the amount and source of enteral feeding (i.e., human milk fortifiers or milk formula). At 28±2 days of age, blood samples will be obtained for 25(OH)D concentration measurement, followed by measurements every 4 weeks and/or 35±1 weeks of PCA. In the monitored group, vit D doses will be appropriately modified, based on 25(OH)D levels, using the scheme described in the Polish recommendation. The intake from the diet will be calculated from the second month of life.
cholecalciferol/ Devikap
Dietary supplementInfants in the controlled group will receive 250 IU for very low birth weight infants and 500 IU for infants weighing above 1000 g. An additional 160 IU/kg of vit D is included in parenteral nutrition, as well as 150-300 IU/kg in enteral nutrition, depending on the amount and source of enteral feeding (i.e., human milk fortifiers or milk formula). Infants assigned to the standard therapy group will undergo the same blood sample collection procedure as the monitored group, but without any alterations in their dosing regimen.
The number of infants with deficient or suboptimal 25(OH)D levels.
25-hydroxyvitamin D serum level below 30ng/ml
The number of infants with neonatal late-onset sepsis.
blood culture-proven (one blood sample of at least 1 mL) and/or clinical sepsis occurring after 3 days of age
The number of infants with biochemical markers of metabolic bone disease.
serum levels of alkaline phosphatase \>500 IU and serum phosphate \<1.8 mmol/L
The number of infants with hyperparathyroidism.
serum or plasma concentration of PTH in infants should be 10-40 pg/mL
The number of infants with high interleukin-6 levels.
the reference interval is calculated as 44 pg/mL; it is released within 2 h after the onset of bacteremia, peaks at approximately 6 h, and finally declines over the following 24 h
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Princess Anna Mazowiecka Hospital, Warsaw, Poland
Lead sponsor
Medical University of Warsaw
Collaborator
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