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

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ClinicalTrials.gov Identifier: NCT01812681
Recruitment Status : Completed
First Posted : March 18, 2013
Results First Posted : August 12, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Serdar Beken, Dr. Sami Ulus Children's Hospital

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.

Condition or disease
Respiratory Distress Syndrome

Detailed 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.

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Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013


Group/Cohort
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



Primary Outcome Measures :
  1. Respiratory Distress Syndrome [ Time Frame: three days ]
    The association of vitamin D level with respiratory distress syndrome


Secondary Outcome Measures :
  1. Sepsis [ Time Frame: four weeks ]
    Association of vitamin D level with sepsis



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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature infants
Criteria

Inclusion Criteria:

  • infants <32 weeks of gestational age

Exclusion Criteria:

  • infants with major congenital abnormality
  • infants >32 weeks of gestational age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812681


Locations
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Turkey
Sami Ulus CH
Ankara, Turkey, 06120
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
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Study Director: Dilek Dilli, Assoc Prof Sami Ulus CH
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Serdar Beken, MD, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT01812681    
Other Study ID Numbers: B.10.4.İSM.4.06.68.49
B.10.4.İSM.4.06.68.49 ( Other Identifier: Ethics Committe )
First Posted: March 18, 2013    Key Record Dates
Results First Posted: August 12, 2014
Last Update Posted: August 15, 2014
Last Verified: August 2014
Keywords provided by Serdar Beken, Dr. Sami Ulus Children's Hospital:
vitamin D, Respiratory distress syndrome, sepsis, preterm
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases