Neonatal DiseaseNCT04073342
Intestinal Genes Expression Associated With Necrotizing Enterocolitis
An observational study of Neonatal Disease, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Neonatal Disease
- What is being tested?
- Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- Child
Study population: Surgical cases of necrotizing enterocolitis and control from babies with intestinal operations for non necrotizing enterocolitis pathology (preterm and term infants).
Who may be able to join
- Cases of necrotizing enterocolitis diagnosed by modified Bells criteria, radiological picture and need surgical intervention.
Who cannot join
- Cases of severe intrauterine growth retardation.
- Cases with severe congenital anomalies.
About this study
Official title: 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.
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.
- Conditions
- Neonatal Disease
- Being tested
- Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).Genetic
Ileal tissue from both group will be tested for gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).
| Study group | Role | What they receive |
|---|---|---|
| Surgical Necrotizing enterocolitis | Cases of preterm infants with necrotizing enterocolitis need surgical intervention Receives: 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. Receives: Genetic: Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal gene expression
Intestinal gene expression of interleukin 8
Measured: 2 years
Toll like receptor 4
Gene expression of Toll like receptor 4 in cases of necrotizing enterocolitis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neonatal DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASAli, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073342
- Sponsor's protocol ID
- gene expression in necrotizing
- Status last verified
- Aug 2019
- First submitted
- 27 Aug 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 29317459Ganapathy 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 21718117Federici S, De Biagi L. Long Term Outcome of Infants with NEC. Curr Pediatr Rev. 2019;15(2):111-114. doi: 10.2174/1573396315666181130144925.
PubMed 30499415Willems 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.
PubMed 26111029Gibbons 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Mediators and Intestinal Genes Expression Associated With Necrotizing Enterocolitis in Preterm Infants
- ClinicalTrials.gov ID
- NCT04073342
- Acronym / sponsor ID
- gene expression in necrotizing
- Conditions
- Neonatal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Necrotizing enterocolitis | – | Genetic: 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 | – | Genetic: 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. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Age groups
- Child
- Study population
- Surgical cases of necrotizing enterocolitis and control from babies with intestinal operations for non necrotizing enterocolitis pathology (preterm and term infants).
Key inclusion criteria (1 listed)
- Cases of necrotizing enterocolitis diagnosed by modified Bells criteria, radiological picture and need surgical intervention.
Key exclusion criteria (2 listed)
- Cases of severe intrauterine growth retardation.
- Cases with severe congenital anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Genetic | Non Necrotizing enterocolitis, Surgical Necrotizing enterocolitis |
Primary outcome
Intestinal gene expression
Time frame: 2 years
Intestinal gene expression of interleukin 8
Toll like receptor 4
Time frame: 2 years
Gene expression of Toll like receptor 4 in cases of necrotizing enterocolitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Background: PubMed 29317459Battersby 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.
- Background: PubMed 21718117Ganapathy 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.
- Background: PubMed 30499415Federici S, De Biagi L. Long Term Outcome of Infants with NEC. Curr Pediatr Rev. 2019;15(2):111-114. doi: 10.2174/1573396315666181130144925.
- Background: PubMed 26111029Willems 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.
- Background: PubMed 25242415Gibbons 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal gene expression (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04073342, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.