Necrotizing Enterocolities

October 8, 2024 updated by: Mervat maher saad zakhary, Assiut University

Haematological Disturbances in Neonates with Necrotizing Enterocolities

Haematological disturbances in neonates with necrotizing enterocolities

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Necrotizing enterocolitis (NEC) is an acquired, multifactorial and devastating gastrointestinal disease associated with high morbidity and mortality in preterm neonates. With an incidence of about 7% in infants with BW < 1500 g and mortality up to 30%, NEC presents as a medical and surgical emergency It is characterized by ischemia, necrosis, and inflammation of bowel wall with invasion by gas-forming organisms and intramural dissection of gas ,characteristicall appearing as pneumatosis intestinalis in radiological and pathological studies. While exact etiology is undetermined, the pathogenesis is believed to be an anomalous innate immune response to an altered, less diverse intestinal microbiota by the highly immunoreactive enterocytes of premature infants, leading to inflammation and tissue necrosis

  • in this devastating disease with undetermined etiology. Breast milk feeding, prolonging gestation to avoid prematurity, antenatal steroid, and the use of probiotics/prebiotics are established prevention strategies in NEC
  • The hematological abnormalities associated with NEC were first described 25 years ago by Hutter et al.The abnormalities observed in a series of 40 patients with NEC included thrombocytopenia, with
  • and without disseminated intravascular coagulation (DIC), neutrophilia or neutropenia, and hemolytic anemia.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Neonates with necrotizing enterocolities

Description

Inclusion Criteria:

  • preterm less than 36 weeks
  • Or very low birth weight less than 1500 gram

Exclusion Criteria:

  • full term
  • Normal birth weight ,Preterm with early breast feeding or more than 1500 gm

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neonates with necrotizing enterocolities
Diagnostic test: Complete blood count
Study haemtological disturbances in neonates with necrotizing enterocolities
Other: Complete blood count
Haemtological disturbances in neonates with necrotizing enterocolities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim
Time Frame: Baseline
:to delineate haemtological abnormalities in neonatal necrotizing enterocolities as predictors of morbidity and mortality
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 6, 2024

First Submitted That Met QC Criteria

October 6, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Necrotizing enterocolities

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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