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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04344639
Enrollment
500
Registered
2020-04-14
Start date
2019-03-01
Completion date
2020-04-01
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis

Keywords

neonate, newborn, premature, necrotizing enterocolitis, neonatal intensive care unit, infant, incidence, risk factors, Turkey

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.

Interventions

OTHERthe 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.

Sponsors

Turkish Neonatal Society
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 3 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Initiation of enteral feeding time, choice of breastfeeding or formula1 yearnutrition: breastfeeding of formula, delayed enteral feeding
Incidence of Necrotizing Enterocolitis1 yearIncidence: frequency of NEC during study period
Risk factors for mild and severe necrotizing enterocolitis1 yearerytrocyte/FFP/trombocyte transfusions,PDA closing therapy, umbilical artery catheterisation,
severity of necrotizing enrerocolitis1 yearGrade of NEC disease according to modified Bell Criteria
Meconium discharge time1 yearmeconium discharge time (hour)
probiotic usage1 yearprobiotic usage, type of probiotic preparation

Secondary

MeasureTime frameDescription
Prognosis1 yearcomplications: intestinal perforation, requirement of surgery, short bowell syndrome), mortality rate.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026