NCT04277533|CompletedDMC
Predictors of Neonatal Necrotizing Enterocolitis
Evaluation of Some Blood Biomarkers as Predictors of Neonatal Necrotizing Enterocolitis
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Evaluation of Some Blood Biomarkers as Predictors of Neonatal Necrotizing Enterocolitis
Sponsor study identifier
observational
50
1 country
1
Study Start
June 15, 2019
Actual (reported)Primary Completion
December 15, 2019
Actual (reported)Study Completion
February 15, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2019
Actual (reported)December 15, 2019
Actual (reported)February 15, 2020
Actual (reported)February 18, 2020
Actual (reported)February 20, 2020
Actual (reported)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
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 .
Stable preterm neonate with matched gestational and postnatal ages without infectious diseases.
GGT, Ca2+, NLR and TSB are serum markers which had been studied for early detection and prediction of severity of NEC.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Neonates with gestational ages are between 28-36 weeks regardless of birth weight.
Ain Shams university Faculty of medicine
Cairo, 11591, Egypt
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.
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.
Nehal El-Raggal, MD
faculty of medicine ain shams university
Dina Essam
faculty of medicine ain shams university
Azza Hassan
faculty of medicine ain shams university
Yasser Wageih
faculty of medicine ain shams university
50 participants (actual enrollment reported by the registry).
First Submitted
February 18, 2020
First Posted
February 20, 2020
Study Start
June 15, 2019
Actual (reported)Enteral Feeding in Infants With Duct Dependant Lesions.
Contact the study team to confirm eligibility.
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.
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.
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.
Han CQ and Wei XY (2017): Novel biomarkers to determine neonates with necrotizing enterocolitis, Biomedical Research; 28 (13): 6002-6006.
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.
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.
Lin PW, Stoll BJ. Necrotising enterocolitis. Lancet. 2006 Oct 7;368(9543):1271-83. doi: 10.1016/S0140-6736(06)69525-1.
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.
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.
Thompson AM, Bizzarro MJ. Necrotizing enterocolitis in newborns: pathogenesis, prevention and management. Drugs. 2008;68(9):1227-38. doi: 10.2165/00003495-200868090-00004.
Yajamanyam PK, Rasiah SV, Ewer AK. (2014): Necrotizing enterocolitis: current perspectives, Dove Medical Press Limited, Volume 2014:4 Pages 31-42
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.
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.
Yokoyama H. [Gamma glutamyl transpeptidase (gammaGTP) in the era of metabolic syndrome]. Nihon Arukoru Yakubutsu Igakkai Zasshi. 2007 Jun;42(3):110-24. Japanese.
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.
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
Primary Completion
December 15, 2019
Actual (reported)Study Completion
February 15, 2020
Actual (reported)Last Updated
August 27, 2020
Record last verified: 2020-08
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