Intestinal Genes Expression Associated With Necrotizing Enterocolitis

Neonatal Disease Clinical Trial

Official title:

Inflammatory Mediators and Intestinal Genes Expression Associated With Necrotizing Enterocolitis in Preterm Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04073342
• Other study ID #: gene expression in necrotizing
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In recent days, necrotizing enterocolitis is one of the most common and devastating problem in preterm infants. Therefore, it became a high growing research topic in the last decade.

The development of medical care increases the survival of preterm babies and consequently increase the number of cases with this serious problem. A systematic review shows the incidence of necrotizing enterocolitis is about 2-7% in babies less than 32weeks gestation and 5-22% in baby's birth weight less than 1000gram.

Description:

In 2011, study on average cost of necrotizing enterocolitis in United States shows average cost of health service for preterm baby without necrotizing enterocolitis and with necrotizing enterocolitis 74,004 $-198,040 $ respectively.Babies surviving from necrotizing enterocolitis are at risk of long term complication such as short bowel syndrome and intestinal stricture.Furthermore, impairment of neurodevelopment and growth are usually observed in these babies.In spite of decades of researches on the disease, pathogenesis of necrotizing enterocolitis still unclear. We still don't know how to prevent and treat the disease. However, advancement of researches in the field of microbiology and cellular biology of the intestine of preterm infants could lead to more understanding for early diagnosis, prevention and proper treatment. Enteral feeding in preterm pigs lead to upregulation of inflammatory and pattern recognition receptor genes including interleukin8 and Toll like receptor-4 with corresponding condensation of chromatin configuration that lead to initiation of inflammatory process and development of necrotizing enterocolitis. It is not known if these changes are present in human preterm bowel.T cell effector function in preterm infant immune response is characterised by preponderance of interleukin-8 producing T-cells and has the potential to activate neutrophils and γδ T cells.γδ T cells are predominant intra-epithelial lymphocyte in immature preterm gut and has a role in maintaining intestinal integrity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1
• Est. completion date: June 1, 2022
• Est. primary completion date: January 1, 2022
• Gender: All
• Age group: N/A to 30 Days

Eligibility

Inclusion Criteria:

• Cases of necrotizing enterocolitis diagnosed by modified Bells criteria, radiological picture and need surgical intervention.

Exclusion Criteria:

• Cases of severe intrauterine growth retardation.

• Cases with severe congenital anomalies.

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Infant, Newborn, Diseases
• Neonatal Disease

Intervention

Genetic:
• Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).
Ileal tissue from both group will be tested for gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

Battersby C, Santhalingam T, Costeloe K, Modi N. Incidence of neonatal necrotising enterocolitis in high-income countries: a systematic review. Arch Dis Child Fetal Neonatal Ed. 2018 Mar;103(2):F182-F189. doi: 10.1136/archdischild-2017-313880. Epub 2018 Jan 9. Review. — View Citation

Federici S, De Biagi L. Long Term Outcome of Infants with NEC. Curr Pediatr Rev. 2019;15(2):111-114. doi: 10.2174/1573396315666181130144925. — View Citation

Ganapathy V, Hay JW, Kim JH. Costs of necrotizing enterocolitis and cost-effectiveness of exclusively human milk-based products in feeding extremely premature infants. Breastfeed Med. 2012 Feb;7(1):29-37. doi: 10.1089/bfm.2011.0002. Epub 2011 Jun 30. — View Citation

Gibbons D, Fleming P, Virasami A, Michel ML, Sebire NJ, Costeloe K, Carr R, Klein N, Hayday A. Interleukin-8 (CXCL8) production is a signatory T cell effector function of human newborn infants. Nat Med. 2014 Oct;20(10):1206-10. doi: 10.1038/nm.3670. Epub 2014 Sep 21. — View Citation

Willems R, Krych L, Rybicki V, Jiang P, Sangild PT, Shen RL, Hensel KO, Wirth S, Postberg J, Jenke AC. Introducing enteral feeding induces intestinal subclinical inflammation and respective chromatin changes in preterm pigs. Epigenomics. 2015;7(4):553-65. doi: 10.2217/epi.15.13. Erratum in: Epigenomics. 2015 Aug;7(5):876. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal gene expression	Intestinal gene expression of interleukin 8	2 years
Primary	Toll like receptor 4	Gene expression of Toll like receptor 4 in cases of necrotizing enterocolitis	2 years