Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey

Study Overview
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Brief Summary
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Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Although it is more common in premature infants, it is also seen in term babies when the intestine is ischemic. Although the major problem in premature babies is the immaturity of the intestine, many factors contributing to immaturity play a role in the pathogenesis of NEC.

Detailed Description
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Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Although it is more common in premature infants, it is also seen in term babies when the intestine is ischemic. Although the major problem in premature babies is the immaturity of the intestine, many factors contributing to immaturity play a role in the pathogenesis of NEC. 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.

Official Title
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Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey: A Prospective Multicentre Study

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Other: the incidence, risk factors, treatment, prognosis of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our country


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborns diagnosed with NEC in neonatal intensive care units Exclusion Criteria: Major congenital anomaly, 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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Necrotizing Enterocolitis | Incidence: frequency of NEC during study period | 1 year | 
| Risk factors for mild and severe necrotizing enterocolitis | erytrocyte/FFP/trombocyte transfusions,PDA closing therapy, umbilical artery catheterisation, | 1 year | 
| Initiation of enteral feeding time, choice of breastfeeding or formula | nutrition: breastfeeding of formula, delayed enteral feeding | 1 year | 
| Meconium discharge time | meconium discharge time (hour) | 1 year | 
| probiotic usage | probiotic usage, type of probiotic preparation | 1 year | 
| severity of necrotizing enrerocolitis | Grade of NEC disease according to modified Bell Criteria | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis | complications: intestinal perforation, requirement of surgery, short bowell syndrome), mortality rate. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonate, newborn, premature, necrotizing enterocolitis, neonatal intensive care unit, infant, incidence, risk factors, Turkey