Intestinal Genes Expression Associated With Necrotizing Enterocolitis

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04073342
Collaborator
(none)
1
29

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).

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 Design

Study Type:
Observational
Anticipated Enrollment :
1 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Inflammatory Mediators and Intestinal Genes Expression Associated With Necrotizing Enterocolitis in Preterm Infants
Anticipated Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. Intestinal gene expression [2 years]

    Intestinal gene expression of interleukin 8

  2. Toll like receptor 4 [2 years]

    Gene expression of Toll like receptor 4 in cases of necrotizing enterocolitis

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 30 Days
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ASAli, Assistant lecturer of pediatric and neonatology , principle investigator,clinical doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT04073342
Other Study ID Numbers:
  • gene expression in necrotizing
First Posted:
Aug 29, 2019
Last Update Posted:
Sep 11, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 11, 2019