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| ID | Type | Description | Link |
|---|---|---|---|
| B.10.4.İSM.4.06.68.49 | Other Identifier | Ethics Committe |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Distress Syndrome | The association of vitamin D level with respiratory distress syndrome | three days |
| Measure | Description | Time Frame |
|---|---|---|
| Sepsis | Association of vitamin D level with sepsis | four weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Premature infants
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| Name | Affiliation | Role |
|---|---|---|
| Dilek Dilli, Assoc Prof | Sami Ulus CH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sami Ulus CH | Ankara | 06120 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20188500 | Background | 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. | |
| 25217734 | Derived | Fettah 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Vitamin D Level | The premature infants with low cord blood vitamin D level |
| FG001 | Normal Vitamin D | The premature infants with normal vitamin D level |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Vitamin D Level | The premature infants with low cord blood vitamin D level |
| BG001 | Normal Vitamin D | The premature infants with normal vitamin D level |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Respiratory Distress Syndrome | The association of vitamin D level with respiratory distress syndrome | Posted | Number | participants | three days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Vitamin D Level | The premature infants with low cord blood vitamin D level |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Serdar Beken | Dr. Sami Ulus Children's Hospital | 00903123056449 | serbeken@gmail.com |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D018805 | Sepsis |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007239 | Infections |
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| BG002 | Total | Total of all reporting groups |
| weeks |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Sepsis | Association of vitamin D level with sepsis | Posted | Number | participants | four weeks |
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|
|
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Normal Vitamin D | The premature infants with normal vitamin D level | 0 | 24 | 0 | 24 |
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| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |