Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey
- Conditions
- Necrotizing Enterocolitis
- Registration Number
- NCT04344639
- Lead Sponsor
- Turkish Neonatal Society
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- Newborns diagnosed with NEC in neonatal intensive care units
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Meconium discharge time 1 year meconium discharge time (hour)
Incidence of Necrotizing Enterocolitis 1 year Incidence: frequency of NEC during study period
Initiation of enteral feeding time, choice of breastfeeding or formula 1 year nutrition: breastfeeding of formula, delayed enteral feeding
Risk factors for mild and severe necrotizing enterocolitis 1 year erytrocyte/FFP/trombocyte transfusions,PDA closing therapy, umbilical artery catheterisation,
probiotic usage 1 year probiotic usage, type of probiotic preparation
severity of necrotizing enrerocolitis 1 year Grade of NEC disease according to modified Bell Criteria
- Secondary Outcome Measures
Name Time Method Prognosis 1 year complications: intestinal perforation, requirement of surgery, short bowell syndrome), mortality rate.
Trial Locations
- Locations (2)
Tolga Hasan Çelik
🇹🇷Ankara, Turkey
Tolga Hasan Çelik, MD
🇹🇷Ankara, Turkey