NCT04073342

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 11, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

August 27, 2019

Last Update Submit

September 10, 2019

Conditions

Neonatal Disease

Outcome Measures

Primary Outcomes (2)

  • Intestinal gene expression

    Intestinal gene expression of interleukin 8

    2 years

  • Toll like receptor 4

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

    2 years

Study Arms (2)

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

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).

Non Necrotizing enterocolitisSurgical Necrotizing enterocolitis

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 29317459BACKGROUND

  • 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.

    PMID: 21718117BACKGROUND

  • Federici S, De Biagi L. Long Term Outcome of Infants with NEC. Curr Pediatr Rev. 2019;15(2):111-114. doi: 10.2174/1573396315666181130144925.

    PMID: 30499415BACKGROUND

  • 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.

    PMID: 26111029BACKGROUND

  • 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.

    PMID: 25242415BACKGROUND

MeSH Terms

Conditions

Infant, Newborn, Diseases

Interventions

Interleukin-8

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Chemokines, CXCChemokinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsInterleukinsProteinsChemotactic FactorsBiological FactorsInflammation Mediators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of pediatric and neonatology , principle investigator,clinical doctor

Study Record Dates

First Submitted

August 27, 2019

First Posted

August 29, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

September 11, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share