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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 1, 2020

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Prognosis
    • Time Frame: 1 year
    • complications: intestinal perforation, requirement of surgery, short bowell syndrome), mortality rate.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 3 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Turkish Neonatal Society
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tolga Hasan Çelik, MD, M.D., Assist. Prof., Division of Neonatology, Department of Pediatrics – Hacettepe University
  • Overall Official(s)
    • Tolga H Çelik, MD, Principal Investigator, Hacettepe University Faculty of Medicine Department of Pediatrics

Citations Reporting on Results

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.

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