Predictors of Neonatal Necrotizing Enterocolitis

NCT04277533 | Completed DMC

• 1 other identifier: necrotizing enterocolitis
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the value of peripheral blood neutrophil to lymphocyte ratio (NLR), serum levels of γ-Glutamyl transferase (GGT), total serum bilirubin and serum calcium (Ca2+) concentrations for early diagnosis and prediction of NEC severity and if found significant, scoring will be done according to their levels in different Bell's stages.

Conditions

Necrotising Enterocolitis

Outcome Measures

Primary Outcomes (1)

• Evaluation of some blood biomarkers as predictors of neonatal necrotizing enterocolitis.

  The peripheral blood neutrophil to lymphocyte ratio (NLR), serum levels of γ-Glutamyl transferase (GGT), total serum bilirubin and serum calcium (Ca2+) concentrations would been studied for early diagnosis and prediction of NEC severity and if found significant, scoring will be done according to their levels in different Bell's stages.

  Baseline

Study Arms (2)

Patient group

NEC preterm neonates with gestational ages are between 28-36 weeks regardless of birth weight. NEC diagnosis and staging will be according to Bell's staging criteria .

Diagnostic Test: Serum γ-Glutamyl transferase (GGT), Total serum bilirubin (TSB), Serum calcium concentration (Ca2+), Peripheral blood neutrophil to lymphocyte ratio (NLR)

Control group

Stable preterm neonate with matched gestational and postnatal ages without infectious diseases.

Diagnostic Test: Serum γ-Glutamyl transferase (GGT), Total serum bilirubin (TSB), Serum calcium concentration (Ca2+), Peripheral blood neutrophil to lymphocyte ratio (NLR)

Interventions

Serum γ-Glutamyl transferase (GGT), Total serum bilirubin (TSB), Serum calcium concentration (Ca2+), Peripheral blood neutrophil to lymphocyte ratio (NLR) DIAGNOSTIC_TEST

GGT, Ca2+, NLR and TSB are serum markers which had been studied for early detection and prediction of severity of NEC.

Control group; Patient group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates with gestational ages are between 28-36 weeks regardless of birth weight.

You may qualify if:

• Patient group: NEC preterm neonates with gestational ages are between 28-36 weeks regardless of birth weight. NEC diagnosis and staging will be according to Bell's staging criteria.
• Control group: Stable preterm neonate with matched gestational and postnatal ages without infectious diseases will be included.

You may not qualify if:

• Neonates with congenital infectious diseases, perinatal asphyxia, severe birth defects, congenital digestive tract malformations, inherited metabolic diseases or parental refusal of enrollment.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university Faculty of medicine

Cairo, 11591, Egypt

Location

Related Publications (18)

• Bell MJ, Ternberg JL, Feigin RD, Keating JP, Marshall R, Barton L, Brotherton T. Neonatal necrotizing enterocolitis. Therapeutic decisions based upon clinical staging. Ann Surg. 1978 Jan;187(1):1-7. doi: 10.1097/00000658-197801000-00001.

  PMID: 413500 BACKGROUND

• Cabrera-Abreu JC, Green A. Gamma-glutamyltransferase: value of its measurement in paediatrics. Ann Clin Biochem. 2002 Jan;39(Pt 1):22-5. doi: 10.1258/0004563021901685.

  PMID: 11853185 BACKGROUND

• de Jager CP, van Wijk PT, Mathoera RB, de Jongh-Leuvenink J, van der Poll T, Wever PC. Lymphocytopenia and neutrophil-lymphocyte count ratio predict bacteremia better than conventional infection markers in an emergency care unit. Crit Care. 2010;14(5):R192. doi: 10.1186/cc9309. Epub 2010 Oct 29.

  PMID: 21034463 BACKGROUND

• Fereshtehnejad SM, Poorsattar Bejeh Mir K, Poorsattar Bejeh Mir A, Mohagheghi P. Evaluation of the possible antioxidative role of bilirubin protecting from free radical related illnesses in neonates. Acta Med Iran. 2012;50(3):153-63.

  PMID: 22418983 BACKGROUND

• Gordon PV, Swanson JR, Attridge JT, Clark R. Emerging trends in acquired neonatal intestinal disease: is it time to abandon Bell's criteria? J Perinatol. 2007 Nov;27(11):661-71. doi: 10.1038/sj.jp.7211782. Epub 2007 Jul 5.

  PMID: 17611610 BACKGROUND

• Han CQ and Wei XY (2017): Novel biomarkers to determine neonates with necrotizing enterocolitis, Biomedical Research; 28 (13): 6002-6006.

  BACKGROUND

• Levitt DG, Levitt MD. Quantitative assessment of the multiple processes responsible for bilirubin homeostasis in health and disease. Clin Exp Gastroenterol. 2014 Sep 2;7:307-28. doi: 10.2147/CEG.S64283. eCollection 2014.

  PMID: 25214800 BACKGROUND

• Li B, Zhang ZL, Yang ZZ, Zhang HZ. (2012): Application value of neutrophil and lymphocyte count ratio in respiratory tract infectious diseases. Zhong Guo Xue Ye Liu Bian Xue Za Zhi; 22: 522-524. In Chinese.

  BACKGROUND

• Lin PW, Stoll BJ. Necrotising enterocolitis. Lancet. 2006 Oct 7;368(9543):1271-83. doi: 10.1016/S0140-6736(06)69525-1.

  PMID: 17027734 BACKGROUND

• Stocker R, Yamamoto Y, McDonagh AF, Glazer AN, Ames BN. Bilirubin is an antioxidant of possible physiological importance. Science. 1987 Feb 27;235(4792):1043-6. doi: 10.1126/science.3029864.

  PMID: 3029864 BACKGROUND

• Terrin G, Stronati L, Cucchiara S, De Curtis M. Serum Markers of Necrotizing Enterocolitis: A Systematic Review. J Pediatr Gastroenterol Nutr. 2017 Dec;65(6):e120-e132. doi: 10.1097/MPG.0000000000001588.

  PMID: 28379923 BACKGROUND

• Thompson AM, Bizzarro MJ. Necrotizing enterocolitis in newborns: pathogenesis, prevention and management. Drugs. 2008;68(9):1227-38. doi: 10.2165/00003495-200868090-00004.

  PMID: 18547133 BACKGROUND

• Yajamanyam PK, Rasiah SV, Ewer AK. (2014): Necrotizing enterocolitis: current perspectives, Dove Medical Press Limited, Volume 2014:4 Pages 31-42

  BACKGROUND

• Yang M, Li L, Su N, Lin J, Wang J. [Dynamic monitoring of the neutrophil/lymphocyte ratio could predict the prognosis of patients with bloodstream infection]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2015 Jun;27(6):471-6. doi: 10.3760/cma.j.issn.2095-4352.2015.06.011. Chinese.

  PMID: 26049186 BACKGROUND

• Yang Y, Cao ZL, Zhou XY, Chen XQ, Pan JJ, Cheng R. Does neutrophil/lymphocyte ratio have good diagnostic value in neonatal necrotizing colitis? J Matern Fetal Neonatal Med. 2019 Sep;32(18):3026-3033. doi: 10.1080/14767058.2018.1455182. Epub 2018 Mar 27.

  PMID: 29557695 BACKGROUND

• Yokoyama H. [Gamma glutamyl transpeptidase (gammaGTP) in the era of metabolic syndrome]. Nihon Arukoru Yakubutsu Igakkai Zasshi. 2007 Jun;42(3):110-24. Japanese.

  PMID: 17665541 BACKGROUND

• Zahorec R. Ratio of neutrophil to lymphocyte counts--rapid and simple parameter of systemic inflammation and stress in critically ill. Bratisl Lek Listy. 2001;102(1):5-14. English, Slovak.

  PMID: 11723675 BACKGROUND

• Zimmerman K., Daniel K. (2018): Principals and practice of pediatric infectious diseases textbook, Chapter H. Gastrointestinal Tract Infections and Intoxications, necrotizing enterocolitis; page 394-397

  BACKGROUND

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Nehal El-Raggal, MD

  faculty of medicine ain shams university

  STUDY DIRECTOR

• Dina Essam

  faculty of medicine ain shams university

  STUDY DIRECTOR

• Azza Hassan

  faculty of medicine ain shams university

  STUDY DIRECTOR

• Yasser Wageih

  faculty of medicine ain shams university

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR Esraa Ragab Zaki

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: June 15, 2019
• Primary Completion: December 15, 2019
• Study Completion: February 15, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)