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

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

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.

Study Overview

• Status: Completed
• Conditions: Necrotizing Enterocolitis
• Intervention / Treatment: Other: the incidence, risk factors, treatment, prognosis of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our country

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Tolga Hasan Çelik, MD
  • Ankara, Turkey, 06100
    • Tolga Hasan Çelik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Newborns diagnosed with NEC in neonatal intensive care units.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Turkish Neonatal Society
• Investigators: Principal Investigator: Tolga H Çelik, MD, Hacettepe University Faculty of Medicine Department of Pediatrics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: risk factors; incidence; infant; newborn; neonate; premature; necrotizing enterocolitis; neonatal intensive care unit; Turkey
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: TurkishNECStudyGroup

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This study project is planned as a national multi-center study. This study will be carried out through a Web Based Multicenter Work System, which was formed by the Turkish Neonatal Society.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No