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Status unknownNCT03257553Updated Jan 23, 2018

Ultrasound, Doppler ,and Calprotectin in Necrotizing Enterocolitis Diagnosis

An interventional study of fecal calprotectin , doppler and ultrasound in Necrotizing Enterocolitis, sponsored by Assiut University. Status unknown. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
1 Day to 28 Days
Sex
All
01

Study 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)

Read the detailed description

Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants. It affects annually 0.72 infants per 1000 live births among all neonates and 33 infants per 1000 live births among very low-birth-weight (below 1500 gram).

Necrotising enterocolitis presents with both gastrointestinal and systemic signs. Gastrointestinal signs as delayed gastric emptying, abdominal distention and bloody stools. Non specific signs as lethargy, apnea, respiratory distress.

Although clinical and characteristic radiological findings remain the most important tools so far. Unfortunately, these signs are usually detectable in an advanced stage of disease.

  • Haematological studies as severe or persistent thrombocytopenia, neutropenia, coagulopathy, or acidosis might indicate severe disease.
  • Serial C-reactive protein : that persistently high C-reactive protein indicated developing complications, such as stricture or abscess.

Unfortunately, the majority of these biomarkers lack accuracy in preclinical stage and do not allow proper discrimination from sepsis Therefore, the search for disease-specific, early and noninvasive diagnostic biomarkers remains warranted.

Calprotectin, a peptide secreted by neutrophils and macrophages and is a useful laboratory biomarker for diagnosing necrotizing enterocolitis . Its non-specific biomarkers of inflammation, but the nature of the specimen, e.g. stool, renders these mediators more indicative of the site of tissue injury. And its levels may be a marker for early diagnosis and resolution of gastrointestinal illness , but its utility for early diagnosis and assessment of resolution of necrotizing enterocolitis needs to be studied in a larger studies.

Plain X ray: Definite signs include pneumatosis intestinalis (intramural air) and portal venous gas .

Ultrasound : More sensitive and accurate imaging studies and could become helpful adjuncts to abdominal films in the diagnosis of necrotizing enterocolitis .

The major advantage of sonography over plain abdominal radiography is its superiority in depicting small amount of gas. Ultrasound with Doppler might be more sensitive than abdominal films for detecting necrotic bowel requiring surgical intervention.

When necrotizing enterocolitis is suspected, infants are given bowel rest , bowel decompression, and broad-spectrum antibiotics (after cultures are obtained). Anaerobic coverage should be considered. Adjunctive therapy includes cardiovascular, pulmonary, and haematological support as clinically indicated.

The two main options available for the surgical management of necrotizing enterocolitis are exploratory laparotomy and primary peritoneal drainage .

02

Conditions studied

  • Necrotizing Enterocolitis
03

Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:surgical problems other than NEC ,NEC beyond neonatal period.

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04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    intervention arm

    do fecal calprotectin, doppler and ultrasound for each patient

    Diagnostic Test: fecal calprotectin , doppler and ultrasound

Interventions

  • Diagnostic testfecal calprotectin , doppler and ultrasound

    faecal sample for measurement of calprotectin level ultrasound and doppler

05

What researchers measure

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

    Time frame: one year

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03257553
Lead sponsor
Assiut University
Responsible party
Azhar Arabi mohammed (principal investigator, Assiut University) — Principal investigator
First posted
Aug 22, 2017
Start date
Apr 2018 (estimated)
Primary completion
Oct 2018 (estimated)
Completion
Apr 2019 (estimated)
Last update
Jan 23, 2018

Study contacts

Abdel Latif Abdel Moez, MD
Contact
abdellatefabdelmoez@yahoo.co.uk
01005208016
Ismail Lotfy Mohamad, MD
Contact
drsomaa@yahoo.com
01063398967
Azhar Arabi, MD
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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