Status:
NOT_YET_RECRUITING
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
Lead Sponsor:
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Collaborating Sponsors:
Medical University of Warsaw
Conditions:
Vitamin D Deficiency
Osteopenia of Prematurity
Eligibility:
All Genders
1-2 years
Phase:
NA
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 infa...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06199102
Start Date
September 1 2024
End Date
December 31 2027
Last Update
January 10 2024
Active Locations (1)
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1
Princess Anna Mazowiecka Hospital
Warsaw, Poland, 00-315