Clinical trial NCT04344639: Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey
Official title: Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey: A Prospective Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotizing Enterocolitis
Keywords: neonate
newborn
premature
necrotizing enterocolitis
neonatal intensive care unit
infant
incidence
risk factors
Turkey
Lead sponsor: Turkish Neonatal Society
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newborns diagnosed with NEC in neonatal intensive care units.

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.

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

Primary outcomes:
measure: Incidence of Necrotizing Enterocolitis
timeFrame: 1 year
measure: Risk factors for mild and severe necrotizing enterocolitis
timeFrame: 1 year
measure: Initiation of enteral feeding time, choice of breastfeeding or formula
timeFrame: 1 year
measure: Meconium discharge time
timeFrame: 1 year
measure: probiotic usage
timeFrame: 1 year
measure: severity of necrotizing enrerocolitis
timeFrame: 1 year
Secondary outcomes:
measure: Prognosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Tolga Hasan Çelik, MD
city: Ankara
country: Turkey
facility: Tolga Hasan Çelik
Study officials:
affiliation: Hacettepe University Faculty of Medicine Department of Pediatrics
name: Tolga H Çelik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neu J. Necrotizing enterocolitis. World Rev Nutr Diet. 2014;110:253-63. doi: 10.1159/000358474. Epub 2014 Apr 11.
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.
citation: 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.
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;21(2):436-44. doi: 10.1097/MIB.0000000000000184.