Status:
COMPLETED
A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis
Lead Sponsor:
Mansoura University Children Hospital
Conditions:
Prematurity
Late-onset Sepsis
Eligibility:
All Genders
3-28 years
Phase:
PHASE1
Brief 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...
Detailed 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 t...
Eligibility Criteria
Inclusion
- Preterm Infants (28-37 wk gestational age)
- Late-onset sepsis defined as clinical signs suggestive of infection after 72 h of birth. Clinical sepsis will be defined as the presence of three or more of the following categories of clinical signs:
- Temperature instability (hypothermia, hyperthermia);
- Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis);
- Neurologic (hypotonia, lethargy, seizures);
- Gastrointestinal (feeding intolerance, abdominal distension).
Exclusion
- Major congenital anomalies.
- Chromosomal anomalies.
- Known inborn error(s) of metabolism
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02273843
Start Date
September 1 2013
End Date
August 1 2015
Last Update
September 30 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Neonatal Intensive Care Unit, Mansoura University Children Hospital
Al Mansurah, Dakahlia Governorate, Egypt, 35516