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Status unknownNCT04073342Updated Sep 11, 2019

Intestinal Genes Expression Associated With Necrotizing Enterocolitis

An observational study in Neonatal Disease, sponsored by Assiut University. Status unknown. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2019-09-11.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
1 Day to 30 Days
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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In context

Enterocolitis

216 studies on the registry are indexed under Enterocolitis; 26 are open to participants now.

This study's planned enrollment of 1 is below the median of 78 across 86 observational studies indexed under Enterocolitis.

Browse Enterocolitis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 30 Days
Sexes eligible
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).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Cases of severe intrauterine growth retardation.
  • Cases with severe congenital anomalies.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (estimated)
Patient registry
No

Groups and cohorts

  • 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).

  • 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).

Interventions

  • GeneticGene 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).

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What researchers measure

Primary outcomes

  1. Intestinal gene expression

    Intestinal gene expression of interleukin 8

    Time frame: 2 years

  2. Toll like receptor 4

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

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 29317459 ↗
  • 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. PubMed 21718117 ↗
  • Federici S, De Biagi L. Long Term Outcome of Infants with NEC. Curr Pediatr Rev. 2019;15(2):111-114. doi: 10.2174/1573396315666181130144925. PubMed 30499415 ↗
  • 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. doi: 10.2217/epi.15.62. PubMed 26111029 ↗
  • 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. PubMed 25242415 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04073342
Lead sponsor
Assiut University
Responsible party
ASAli (Assistant lecturer of pediatric and neonatology , principle investigator,clinical doctor, Assiut University) — Principal investigator
First posted
Aug 29, 2019
Start date
Jan 1, 2020 (estimated)
Primary completion
Jan 1, 2022 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Sep 11, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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