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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Infections Inflammation Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Determining maternal and neonatal vitamin D levels

Other

Primary outcomes

development of early onset sepsis

Time frame: 1 year

A total of 100 infants will be included and vitamin D levels will be compared between those with and without neonatal sepsis

Secondary outcomes

severity of vitamin D deficiency and neonatal sepsis

Time frame: one year

Infants will be divided into three groups in terms of mild, moderate and severe vitamin D deficiency according to maternal and neonatal vitamin D levels and a possible association between vitamin D deficiency and culture proven sepsis will be investigated.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Dec 24, 2013
Registry last updated: Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed