Ultrasound, Doppler ,and Calprotectin in Necrotizing Enterocolitis Diagnosis

NCT03257553 | Unknown

• 1 other identifier: UDFNEC
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants due to advances in neonatal intensive care that increase the survival rate of extremely low birth weight infants (below 1,000 gram)

Conditions

Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

• diagnosis of necrotizing enterocolitis

  diagnosis of necrotizing enterocolitis by ultrasound, doppler and calprotectin and compare to see more sensitive and specific method of them in comparison with plain erect

  one year

Study Arms (1)

intervention arm

EXPERIMENTAL

do fecal calprotectin, doppler and ultrasound for each patient

Diagnostic Test: fecal calprotectin , doppler and ultrasound

Interventions

fecal calprotectin , doppler and ultrasound DIAGNOSTIC_TEST

faecal sample for measurement of calprotectin level ultrasound and doppler

intervention arm

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Include All cases with necrotizing enterocolitis (NEC) in assiut university neonatal intensive care unit (NICU) who are presented with any stage of Bell's stages of necrotising enterocolitis within one year .
• I. Suspected disease Mild systemic signs (apnoea, bradycardia, temperature instability) Mild intestinal signs (abdominal distention, gastric residuals, bloody stools) Non-specific or normal radiological signs II. Definite disease Mild to moderate systemic signs Additional intestinal signs (absent bowel sounds, abdominal tenderness) Specific radiologic signs (pneumatosis intestinalis or portal venous air) Laboratory changes (metabolic acidosis, thrombocytopaenia) III. Advanced disease Severe systemic illness (hypotension) Additional intestinal signs (striking abdominal distention, peritonitis) Severe radiological signs (pneumoperitoneum) Additional laboratory changes (metabolic and respiratory acidosis, disseminated intravascular coagulopathy).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Echocardiography, Doppler; Ultrasonography

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography, Doppler; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Azhar Arabi, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdel Latif Abdel Moez, MD

CONTACT

01005208016; abdellatefabdelmoez@yahoo.co.uk

Ismail Lotfy Mohamad, MD

CONTACT

01063398967; drsomaa@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 22, 2017
• Study Start: April 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: April 1, 2019
• Last Updated: January 23, 2018

Record last verified: 2018-01