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NCT Number: NCT06632041

Necrotizing Enterocolities

Haematological disturbances in neonates with necrotizing enterocolities

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Key information

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complete blood count

Diagnostic Test

Study haemtological disturbances in neonates with necrotizing enterocolities

complete blood count

Other

Haemtological disturbances in neonates with necrotizing enterocolities

Primary outcomes

  1. Aim

    Time frame: Baseline

    :to delineate haemtological abnormalities in neonatal necrotizing enterocolities as predictors of morbidity and mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Mervat Maher Zakhary

CONTACT

[email protected]

01026767826

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Haematological Disturbances in Neonates with Necrotizing Enterocolities

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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