Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey
NCT ID: NCT04344639
Last Updated: 2020-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2019-03-01
2020-04-01
Brief Summary
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Detailed Description
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With this study project, which is planned as a national multicenter prospective study, the incidence of necrotizing enterocolitis in newborn infants born in neonatal intensive care units in our country and the risk factors associated with the NEC, especially the detailed feeding history of the patient (when the first feeding is nourished, antibiotics and other treatments that are being used). Most epidemiological data such as the most common stage of the disease, treatment, prognosis, comparison with the data of other countries will provide important information for the neonatal health of our country.
The aim of this study was to determine the factors affecting the emergence of NEC in neonatal intensive care units and to determine the frequency of NEC.
Study Hypothesis: Delayed enteral feeding, intensive use of antibiotics and nutrients other than breast milk increase the incidence of necrotizing enterocolitis.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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the incidence, risk factors, treatment, prognosis of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our country
With this project, which is planned as a national multicenter prospective study, the incidence of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our country and the risk factors associated with the disease, especially the detailed feeding history of the patient (when the first feeding is nourished, antibiotics and other treatments that are being used). Most epidemiological data such as the most common stage of the disease, treatment, prognosis, comparison with the data of other countries will provide important information for the neonatal health of our country.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* congenital heart disease (except for atrial septal defect, ventricular septal defect, patent ductus arteriosus)
* Chromosomal anomaly
* Inherited metabolic disease
* Hypoxic ischemic encephalopathy
* Newborns who died within the first 48 hours of life
1 Day
3 Months
ALL
No
Sponsors
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Turkish Neonatal Society
OTHER
Responsible Party
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Tolga Hasan Çelik, MD
M.D., Assist. Prof., Division of Neonatology, Department of Pediatrics
Principal Investigators
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Tolga H Çelik, MD
Role: PRINCIPAL_INVESTIGATOR
Hacettepe University Faculty of Medicine Department of Pediatrics
Locations
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Tolga Hasan Çelik, MD
Ankara, , Turkey (Türkiye)
Tolga Hasan Çelik
Ankara, , Turkey (Türkiye)
Countries
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References
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Neu J. Necrotizing enterocolitis. World Rev Nutr Diet. 2014;110:253-63. doi: 10.1159/000358474. Epub 2014 Apr 11.
Lim JC, Golden JM, Ford HR. Pathogenesis of neonatal necrotizing enterocolitis. Pediatr Surg Int. 2015 Jun;31(6):509-18. doi: 10.1007/s00383-015-3697-9. Epub 2015 Apr 9.
Kasivajjula H, Maheshwari A. Pathophysiology and current management of necrotizing enterocolitis. Indian J Pediatr. 2014 May;81(5):489-97. doi: 10.1007/s12098-014-1388-5. Epub 2014 Mar 22.
Niemarkt HJ, de Meij TG, van de Velde ME, van der Schee MP, van Goudoever JB, Kramer BW, Andriessen P, de Boer NK. Necrotizing enterocolitis: a clinical review on diagnostic biomarkers and the role of the intestinal microbiota. Inflamm Bowel Dis. 2015 Feb;21(2):436-44. doi: 10.1097/MIB.0000000000000184.
Other Identifiers
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TurkishNECStudyGroup
Identifier Type: -
Identifier Source: org_study_id
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