Necrotizing Enterocolities

Not yet recruiting

• Conditions: Necrotizing Enterocolitis of Newborn
• Interventions: Other: Complete blood count

• Registration Number: NCT06632041
• Lead Sponsor: Assiut University

Brief Summary

Haematological disturbances in neonates with necrotizing enterocolities

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-06
• Study First Submitted QC: 2024-10-06
• Study First Posted: 2024-10-08
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Study Start: 2025-01-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neonates with necrotizing enterocolities	Complete blood count	-

Primary Outcome Measures

Name	Time	Method
Aim	Baseline	:to delineate haemtological abnormalities in neonatal necrotizing enterocolities as predictors of morbidity and mortality