Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities
Is Higher Cord Blood 25(Oh)-Vitamin D Level Preventive For Any Morbidity Including Rds, Pda, Nec, Bpd And Rop In Preterm Infants
1 other identifier
observational
81
1 country
1
Brief Summary
Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. The aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities including RDS, PDA, NEC, BPD AND ROP in preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 14, 2013
CompletedFirst Posted
Study publicly available on registry
March 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
August 12, 2014
CompletedAugust 15, 2014
August 1, 2014
1 year
March 14, 2013
July 17, 2014
August 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Respiratory Distress Syndrome
The association of vitamin D level with respiratory distress syndrome
three days
Secondary Outcomes (1)
Sepsis
four weeks
Study Arms (2)
Low vitamin D level
The premature infants with low cord blood vitamin D level
Normal Vitamin D
The premature infants with normal vitamin D level
Eligibility Criteria
Premature infants
You may qualify if:
- infants \<32 weeks of gestational age
You may not qualify if:
- infants with major congenital abnormality
- infants \>32 weeks of gestational age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sami Ulus CH
Ankara, 06120, Turkey (Türkiye)
Related Publications (2)
Grant WB. Vitamin D supplementation of mother and infant could reduce risk of sepsis in premature infants. Early Hum Dev. 2010 Feb;86(2):133. doi: 10.1016/j.earlhumdev.2010.02.003. Epub 2010 Feb 25. No abstract available.
PMID: 20188500BACKGROUNDFettah ND, Zenciroglu A, Dilli D, Beken S, Okumus N. Is higher 25-hydroxyvitamin D level preventive for respiratory distress syndrome in preterm infants? Am J Perinatol. 2015 Feb;32(3):247-50. doi: 10.1055/s-0034-1383849. Epub 2014 Sep 13.
PMID: 25217734DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Serdar Beken
- Organization
- Dr. Sami Ulus Children's Hospital
Study Officials
- STUDY DIRECTOR
Dilek Dilli, Assoc Prof
Sami Ulus CH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 14, 2013
First Posted
March 18, 2013
Study Start
October 1, 2012
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
August 15, 2014
Results First Posted
August 12, 2014
Record last verified: 2014-08