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

Turkish Neonatal Society2 sites in 1 country500 target enrollmentMarch 1, 2019

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2019

End Date

April 1, 2020

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Turkish Neonatal Society

Responsible Party

Principal Investigator

Tolga Hasan Çelik, MD

M.D., Assist. Prof., Division of Neonatology, Department of Pediatrics

Hacettepe University

Eligibility Criteria

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