Late-Onset Neonatal Sepsis, Metabolic Bone Disease, Nephrolithiasis, Osteopenia of Prematurity, Vitamin D Deficiency
Conditions
Keywords
vitamin D, preterm infants, osteopenia of prematurity, late-onset sepsis, metabolic bone disease
Brief summary
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.
Detailed description
Vitamin D deficiency can escalate prematurity bone disease in preterm infants and negatively influence their immature immunology system. Infants born at 24+0/7 weeks to 32+6/7 weeks of gestation will be considered for inclusion. Cord or vein blood samples will be obtained within 48 h after birth for 25-hydroxyvitamin D level measurements. Parathyroid hormone and interleukin-6 levels will be measured. Infants will be randomized to the monitored group (i.e., initial dose of 1000 IU/day and possible modification) or the controlled group (i.e., 250 IU/day or 500 IU/day dose, depending on weight). Supplementation will be monitored up to postconceptional age 35 weeks. The primary endpoint is the percentage of infants with deficient or suboptimal 25-hydroxyvitamin D levels at 28±2 days of age. 25-Hydroxyvitamin D levels will be measured at postconceptional age 35±2 weeks. Secondary objectives include the incidence of sepsis, osteopenia, hyperparathyroidism, and elevated interleukin-6 concentration. The aim of this study will be to assess the effectiveness of monitored vitamin D supplementation in a population of preterm infants and to determine whether a high initial dose of monitored vitamin D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.
Interventions
DIETARY_SUPPLEMENTcholecalciferol/ Devikap
Infants 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.
Sponsors
Medical University of Warsaw
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 2 Days
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * the absence of written informed consent and challenges in communication with caregivers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of infants with deficient or suboptimal 25(OH)D levels. | at 28±2 days of age, after that every 4 weeks (number of measurements depends on gestation age at birth) and/ or at 35±1 weeks of postconceptional age | 25-hydroxyvitamin D serum level below 30ng/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of infants with biochemical markers of metabolic bone disease. | at 35±1 weeks of postconceptional age | serum levels of alkaline phosphatase \>500 IU and serum phosphate \<1.8 mmol/L |
| The number of infants with hyperparathyroidism. | at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age | serum or plasma concentration of PTH in infants should be 10-40 pg/mL |
| The number of infants with neonatal late-onset sepsis. | after 3 days of age | 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 nephrocalcinosis and nephrolithiasis. | at 28±2 days of life and at 35±1 weeks of postconceptional age | venous samples for serum and urine calcium, and creatinine level measurements |
| The number of infants with potentially toxic 25(OH)D levels. | at 28±2 days of age, after that every 4 weeks (number of measurements depends on gestation age at birth) and/ or at 35±1 weeks of postconceptional age | 25-hydroxyvitamin D serum level exceeding 100 ng/mL |
| The number of infants with high interleukin-6 levels. | at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age | 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 |
Countries
Poland
Contacts
Primary ContactDominika M Paw, MD
Backup ContactAlicja J Kołodziejczyk-Nowotarska, MD, PhD
Outcome results
None listed