Intestinal Genes Expression Associated With Necrotizing Enterocolitis

• Conditions: Neonatal Disease
• Interventions: Genetic: Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).

• Registration Number: NCT04073342
• Lead Sponsor: Assiut University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-29
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11
• Study Start: 2020-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical Necrotizing enterocolitis	Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).	Cases of preterm infants with necrotizing enterocolitis need surgical intervention
Non Necrotizing enterocolitis	Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).	babies with intestinal operations for non necrotizing enterocolitis pathologies like congenital intestinal obstruction.

Primary Outcome Measures

Name	Time	Method
Intestinal gene expression	2 years	Intestinal gene expression of interleukin 8
Toll like receptor 4	2 years	Gene expression of Toll like receptor 4 in cases of necrotizing enterocolitis