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

NCT02019836 | Completed DMC

• 1 other identifier: MC10000
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

vit D; sepsis; newborn; maternal; neonatal

Outcome Measures

Primary Outcomes (1)

• development of early onset sepsis

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

  1 year

Secondary Outcomes (1)

• severity of vitamin D deficiency and neonatal sepsis

  one year

Study Arms (1)

sepsis group, control group

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

Other: Determining maternal and neonatal vitamin D levels

Interventions

Determining maternal and neonatal vitamin D levels OTHER

sepsis group, control group

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants admitted to neonatal care unit with the diagnosis of high probable sepsis will constitute the sepsis group, whereas infants admitted to outpatient clinic without findings of sepsis will constitute the control group

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Gitto E, Karbownik M, Reiter RJ, Tan DX, Cuzzocrea S, Chiurazzi P, Cordaro S, Corona G, Trimarchi G, Barberi I. Effects of melatonin treatment in septic newborns. Pediatr Res. 2001 Dec;50(6):756-60. doi: 10.1203/00006450-200112000-00021.

  PMID: 11726736 BACKGROUND

• Karatekin G, Kaya A, Salihoglu O, Balci H, Nuhoglu A. Association of subclinical vitamin D deficiency in newborns with acute lower respiratory infection and their mothers. Eur J Clin Nutr. 2009 Apr;63(4):473-7. doi: 10.1038/sj.ejcn.1602960. Epub 2007 Nov 21.

  PMID: 18030309 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Merih Cetinkaya

  Kanuni Sultan Suleyman Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: March 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

TU (1)