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

NCT04344639 | Completed

• 1 other identifier: TurkishNECStudyGroup
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Necrotizing Enterocolitis

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Prognosis

  1 year

Interventions

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.

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Newborns diagnosed with NEC in neonatal intensive care units.

You may qualify if:

• Newborns diagnosed with NEC in neonatal intensive care units

You may not qualify if:

• 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

Sponsors & Collaborators

• Turkish Neonatal Society: lead

Study Sites (2)

Tolga Hasan Çelik, MD

Ankara, 06100, Turkey (Türkiye)

Location

Tolga Hasan Çelik

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (4)

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

  PMID: 24751635 RESULT

• 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.

  PMID: 25854935 RESULT

• 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.

  PMID: 24652270 RESULT

• 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.

  PMID: 25268636 RESULT

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth

Interventions

Risk Factors; Therapeutics; Intensive Care Units, Neonatal

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Intensive Care Units, Pediatric; Intensive Care Units; Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Tolga H Çelik, MD

  Hacettepe University Faculty of Medicine Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Assist. Prof., Division of Neonatology, Department of Pediatrics

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: April 14, 2020
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)