Intestinal Genes Expression Associated With Necrotizing Enterocolitis

September 10, 2019 updated by: ASAli, Assiut University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Surgical cases of necrotizing enterocolitis and control from babies with intestinal operations for non necrotizing enterocolitis pathology (preterm and term infants).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical Necrotizing enterocolitis
Cases of preterm infants with necrotizing enterocolitis need surgical 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).
Non Necrotizing enterocolitis
babies with intestinal operations for non necrotizing enterocolitis pathologies like congenital intestinal obstruction.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal gene expression
Time Frame: 2 years
Intestinal gene expression of interleukin 8
2 years
Toll like receptor 4
Time Frame: 2 years
Gene expression of Toll like receptor 4 in cases of necrotizing enterocolitis
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gene expression in necrotizing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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