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NCT01812681 Clinical Trial

Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities

Respiratory Distress Syndrome Clinical Trial

Official title:
Is Higher Cord Blood 25(Oh)-Vitamin D Level Preventive For Any Morbidity Including Rds, Pda, Nec, Bpd And Rop In Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01812681
Other study ID # B.10.4.ISM.4.06.68.49
Secondary ID B.10.4.ISM.4.06.
Status Completed
Phase N/A
First received March 14, 2013
Last updated August 12, 2014
Start date October 2012
Est. completion date November 2013

Study information
Verified date August 2014
Source Dr. Sami Ulus Children's Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial 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.

Description:

It was shown that vitamin D play important role in the pathogenesis of long term morbidities of newborn. 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.

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date November 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 5 Days
Eligibility Inclusion Criteria:

- infants <32 weeks of gestational age

Exclusion Criteria:

- infants with major congenital abnormality

- infants >32 weeks of gestational age

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Sami Ulus CH Ankara

Sponsors (1)
Lead Sponsor Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory Distress Syndrome The association of vitamin D level with respiratory distress syndrome three days No
Secondary Sepsis Association of vitamin D level with sepsis four weeks No
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