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Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities

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ClinicalTrials.gov Identifier: NCT02147327
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
birgul say, Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary:
Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25 dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone metabolism and also bone morrow, muscle, heart and immune system. For a long time, maternal low vitamin D level is a well known problem for our country and the level was reported as <10 ng/ml for 46-80% of mothers.The most prominent risk factor was determined as low socioeconomic status. Therefore, the level of 25-hydroxy-vitamin D is supposed to be in relation with several neonatal morbidities and maternal complications of pregnancy.

Condition or disease
Neonatal Hypocalcemia Neonatal Sepsis

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D




Primary Outcome Measures :
  1. sepsis [ Time Frame: 3 months but patients will be followed until discharge ]
  2. feeding intolerance [ Time Frame: 3 months but patients will be followed until discharge ]
  3. hypocalcemia [ Time Frame: 3 months but patients will be followed until discharge ]
  4. bronchopulmonary dysplasia [ Time Frame: 3 months but patients will be followed until discharge ]
  5. patent ductus arteriosis [ Time Frame: 3 months but patients will be followed until discharge ]
  6. retinopathy of prematurity [ Time Frame: 3 months but patients will be followed until discharge ]
  7. maternal complications of pregnancy [ Time Frame: from the beginning of gestation until birth process ]

Secondary Outcome Measures :
  1. rachitism [ Time Frame: 4 months but patients will be followed until discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital
Criteria

Inclusion Criteria:

  • Term or preterm newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital

Exclusion Criteria:

  • Preterm babies born before the 24. gestational week
  • Babies with complex cardiac anomalies and/or dysmorphic features
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Responsible Party: birgul say, Fellow in Neonatology, Pediatrician, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02147327    
Other Study ID Numbers: sevit25D3
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014
Keywords provided by birgul say, Zekai Tahir Burak Women's Health Research and Education Hospital:
vitamin D
cord blood
neonatal sepsis
neonatal morbidity
Additional relevant MeSH terms:
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Neonatal Sepsis
Hypocalcemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance