Late-onset Sepsis, Prematurity
Conditions
Keywords
Preterm, late-onset sepsis, Vitamin D, Dose, Interleukin-6, Tumor necrosis factor-alpha
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) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of these infants.
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 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
Interventions
DRUGHigh-dose vitamin D 3
Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 800 IU from the time of diagnosis of sepsis until discharge from the NICU
DRUGConventional-Dose Vitamin D 3
Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 400 IU from the time of diagnosis of sepsis until discharge from the NICU
Sponsors
Mansoura University Children Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* 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: 1. Temperature instability (hypothermia, hyperthermia); 2. Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis); 3. Neurologic (hypotonia, lethargy, seizures); 4. Gastrointestinal (feeding intolerance, abdominal distension).
Exclusion criteria
* Major congenital anomalies. * Chromosomal anomalies. * Known inborn error(s) of metabolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum interleukin-6 | At trial entry and 7 days after daily vitamin D supplementation therapy | Serum levels of interleukin-6 (IL-6) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy. IL-6 concentrations will be determined by Endogenous Interleukin-ELISA |
| Serum tumor necrosis-alpha | At trial entry and 7 days after daily vitamin D supplementation therapy | Serum levels of tumor necrosis-alpha (TNF-alpha) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum calcium, phosphorus and urinary calcium | Participants will be followed for the duration of hospital stay, serum calcium, phosphorus and urinary calcium well be assessed every week for an expected average of 5 weeks | Participants will be followed for the duration of hospital stay, serum calcium, phosphorus and urinary calcium well be assessed every week for an expected average of 5 weeks |
| Abdominal ultrasonography | 40 weeks postmenstrual age | Abdominal ultrasonography to detect any nephrocalcinosis will be done at 40 weeks postmenstrual age |
| Serum C-reactive protein (CRP) | At trial entery and 7 days after daily vitamin D supplementation therapy | Serum CRP will be evaluated at enrollment and 7 days |
| Neonatal morbidities | Participants will be followed for the duration of hospital stay, for an expected average of 4 weeks | Participants will be followed for the duration of hospital stay, for an expected average of 5 weeks and the incidence of neonatal morbidities e.g. NEC, retinopathy of prematurity, disseminated intravascular coagulopathy and renal dysfunction will be assessed |
| Mortality | Baseline | In-hospital mortality during NICU admission for an expected average of 5 weeks |
| Serum 25(OH)D levels | at trial entry, 7 days after daily vitamin D supplementation therapy and at 40 weeks postmenstrual age | Serum 25(OH)D levels will be measured by ELISA at trial entry, at day 7 and at 40 weeks postmenstrual age |
Countries
Egypt
Outcome results
None listed