Comparison of Maternal and Neonatal Vitamin D Levels in Term Neonates With and Without Early Onset Sepsis

Sponsors

Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Source Kanuni Sultan Suleyman Training and Research Hospital
Brief Summary

Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life which is still an important cause of morbidity and mortality. Vitamin D is a fat-soluble steroid hormone that primarily contributes to the maintenance of normal calcium homeostasis and skeletal mineralization. In addition to its classical role in bone metabolism, vitamin D also has immunomodulatory effects on immune function. Although some studies reported a link between vitamin D deficiency and critical illness in adults, a direct relationship has not been directly shown yet. However, to the best of our knowledge, no study evaluated the association between EOS and maternal/neonatal vitamin D levels. The objective of this prospective study is to determine the possible role of maternal and neonatal plasma vitamin D levels on EOS development in term infants. We also aim to evaluate possible effect of the severity of vitamin D deficiency on EOS development in the study population.

Detailed Description

Term infants with clinical and laboratory findings of early onset sepsis who are >37 weeks of gestational age and will be admitted to Neonatal Care Unit of Kanuni Sultan Suleyman Training and Research Hospital will be included in this prospective study. The study group will consist of term neonates who are clinically suspected to have an early infection from the 1st day of life. Blood for neonatal and maternal vitamin D levels will be obtained from all infants and their mothers at the time of hospital admission. Only infants with high probable sepsis will consist the study group. The healthy infants who admit to our outpatient clinic for routine evaluation at postnatal day 3 with no signs of clinical and laboratory infection and are evaluated for hyperbilirubinemia will be referred to as the Control group. The Control group wll consist term infants with the same gestational and postnatal age of the infants that will be included in the study group. In both groups, maternal samples will be obtained at the postpartum period at the time of infant's hospitalization. Plasmas after separated and stored at -800C. Levels of 25-OHD were determined using Shimadzu LC-20AT model High Performance Liquid Chromatography (HPLC) system. Data will be analyzed using SPSS software and appropriate statistical analyses will be performed.

Overall Status Completed
Start Date March 2012
Completion Date January 2013
Primary Completion Date January 2013
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
development of early onset sepsis 1 year
Secondary Outcome
Measure Time Frame
severity of vitamin D deficiency and neonatal sepsis one year
Enrollment 50
Condition
Intervention

Intervention Type: Other

Intervention Name: Determining maternal and neonatal vitamin D levels

Arm Group Label: sepsis group, control group

Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria:

- Infants >37 weeks of gestational age and are admitted to Neonatal Care Unit of Kanuni Sultan Suleyman Training and Research Hospital

- Infants with clinical and laboratory findings of early neonatal sepsis

- Term infants without sepsis as the control group

Exclusion Criteria:

- presence of maternal clinical and/or histological chorioamnionitis,

- presence of premature rupture of membranes (PROM),

- infants with probable or possible sepsis according to criteria,

- refusal of parental consent,

- lack of laboratory data,

- major congenital abnormalities

Gender: All

Minimum Age: N/A

Maximum Age: 72 Hours

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Merih Cetinkaya Study Director Kanuni Sultan Suleyman Training and Research Hospital
Location
Facility: Kanuni Sultan Suleyman Training and Research Hospital
Location Countries

Turkey

Verification Date

December 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Kanuni Sultan Suleyman Training and Research Hospital

Investigator Full Name: Merih Cetinkaya

Investigator Title: Associate Professor, MD, PhD

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: sepsis group, control group

Description: Sepsis group; infants with the diagnosis of high probable sepsis Control group; infants without sepsis

Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov