Intestinal Genes Expression Associated With Necrotizing Enterocolitis

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

Sponsors

Lead Sponsor: Assiut University

Source 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.

Overall Status Not yet recruiting
Start Date January 1, 2020
Completion Date June 1, 2022
Primary Completion Date January 1, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Intestinal gene expression 2 years
Toll like receptor 4 2 years
Enrollment 1
Condition
Intervention

Intervention Type: Genetic

Intervention Name: Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).

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

Eligibility

Sampling Method: Probability Sample

Criteria:

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.

Gender: All

Minimum Age: N/A

Maximum Age: 30 Days

Verification Date

August 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Assiut University

Investigator Full Name: ASAli

Investigator Title: Assistant lecturer of pediatric and neonatology , principle investigator,clinical doctor

Has Expanded Access No
Condition Browse
Arm Group

Label: Surgical Necrotizing enterocolitis

Description: Cases of preterm infants with necrotizing enterocolitis need surgical intervention

Label: Non Necrotizing enterocolitis

Description: babies with intestinal operations for non necrotizing enterocolitis pathologies like congenital intestinal obstruction.

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov