Clinical Trials Logo

Clinical Trial Summary

This is a randomized controlled trial (RCT) to evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of these infants.


Clinical Trial Description

Vitamin D has an important role in the regulation of both the innate and adaptive immune systems. There are very few studies of such roles in the neonatal population. It is potentially an attractive therapeutic agent for sepsis given its low cost and low risk of toxicity and side effects. There is no consensus regarding to the dose of vitamin D supplementation required for preterm infants given the paucity of evidence. AAP and ESPGHAN have recommended different dosages of vitamin D ranging from 400 IU to 1000 IU per day. The influence of different doses of vitamin D on immunological status and clinical outcomes of preterm infants with late-onset sepsis has not been evaluated before. This RCT will evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis we will also evaluate their safety and influence on clinical outcomes of these infants ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02273843
Study type Interventional
Source Mansoura University Children Hospital
Contact
Status Completed
Phase Phase 1
Start date September 2013
Completion date August 2015

See also
  Status Clinical Trial Phase
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Completed NCT05322161 - Yoga in the NICU for Parents Study N/A
Recruiting NCT04542096 - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting NCT04911452 - Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants N/A
Recruiting NCT02901652 - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome N/A
Completed NCT02148965 - Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial N/A
Terminated NCT02032511 - Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP) N/A
Completed NCT01721629 - Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants N/A
Terminated NCT01819532 - Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks N/A
Completed NCT01478711 - Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants N/A
Completed NCT01523769 - Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants N/A
Completed NCT00951860 - Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Completed NCT00749008 - Study of Generalized Movements for Early Prediction of Cerebral Palsy N/A
Terminated NCT01208493 - Dietary Protein in the Very-low-birth-weight Infant N/A
Completed NCT00527956 - Facilitation and Barriers to Breastfeeding in the NICU N/A
Terminated NCT00486395 - Will CPAP Reduce Length Of Respiratory Support In Premature Infants? Phase 3
Completed NCT03372590 - NEO Rehab for Infants at Risk of Cerebral Palsy N/A
Completed NCT00033917 - Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial Phase 3
Completed NCT05508308 - Automated Versus Manual Control Of Oxygen For Preterm Infants On Continuous Positive Airway Pressure In Nigeria N/A