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

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344639
• Other study ID #: TurkishNECStudyGroup
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2020
• Source: Turkish Neonatal Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: April 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Tolga Hasan Çelik	Ankara
Turkey	Tolga Hasan Çelik, MD	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Turkish Neonatal Society

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. Review. — View Citation

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. Review. — View Citation

Neu J. Necrotizing enterocolitis. World Rev Nutr Diet. 2014;110:253-63. doi: 10.1159/000358474. Epub 2014 Apr 11. Review. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Necrotizing Enterocolitis	Incidence: frequency of NEC during study period	1 year
Primary	Risk factors for mild and severe necrotizing enterocolitis	erytrocyte/FFP/trombocyte transfusions,PDA closing therapy, umbilical artery catheterisation,	1 year
Primary	Initiation of enteral feeding time, choice of breastfeeding or formula	nutrition: breastfeeding of formula, delayed enteral feeding	1 year
Primary	Meconium discharge time	meconium discharge time (hour)	1 year
Primary	probiotic usage	probiotic usage, type of probiotic preparation	1 year
Primary	severity of necrotizing enrerocolitis	Grade of NEC disease according to modified Bell Criteria	1 year
Secondary	Prognosis	complications: intestinal perforation, requirement of surgery, short bowell syndrome), mortality rate.	1 year