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Completed

NCT Number: NCT04344639

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

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.

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Key information

Age range

1 day–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Tolga Hasan Çelik, Ankara, Turkey (Türkiye)

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About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the incidence, risk factors, treatment, prognosis of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our country

Other

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.

Primary outcomes

  1. Incidence of Necrotizing Enterocolitis

    Time frame: 1 year

    Incidence: frequency of NEC during study period

  2. Risk factors for mild and severe necrotizing enterocolitis

    Time frame: 1 year

    erytrocyte/FFP/trombocyte transfusions,PDA closing therapy, umbilical artery catheterisation,

  3. Initiation of enteral feeding time, choice of breastfeeding or formula

    Time frame: 1 year

    nutrition: breastfeeding of formula, delayed enteral feeding

  4. Meconium discharge time

    Time frame: 1 year

    meconium discharge time (hour)

  5. probiotic usage

    Time frame: 1 year

    probiotic usage, type of probiotic preparation

  6. severity of necrotizing enrerocolitis

    Time frame: 1 year

    Grade of NEC disease according to modified Bell Criteria

Secondary outcomes

  1. Prognosis

    Time frame: 1 year

    complications: intestinal perforation, requirement of surgery, short bowell syndrome), mortality rate.

Sponsors and collaborators

Lead sponsor

Turkish Neonatal Society

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2020
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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