Predictors of Neonatal Necrotizing Enterocolitis

August 26, 2020 updated by: Esraa Ragab Zaki, Ain Shams University

Evaluation of Some Blood Biomarkers as Predictors of Neonatal Necrotizing Enterocolitis

To assess the value of peripheral blood neutrophil to lymphocyte ratio (NLR), serum levels of γ-Glutamyl transferase (GGT), total serum bilirubin and serum calcium (Ca2+) concentrations for early diagnosis and prediction of NEC severity and if found significant, scoring will be done according to their levels in different Bell's stages.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Necrotizing enterocolitis (NEC) is primarily a disease process of the gastrointestinal tract of neonates that results in inflammation and bacterial invasion of the bowel wall.

Despite extensive research, the pathophysiology of NEC remains unclear and therapeutic options are limited.

Clinical manifestations of NEC may be vague, including increased episodes of apnea, desaturations, bradycardia, lethargy and temperature instability.

There may also be GI-specific symptoms such as feeding intolerance, emesis, bloody stools, abdominal distention and tenderness, and abdominal wall discoloration.

Radiographic signs may include ileus, dilated or fixed intestinal loops, air in the intestinal wall or free air in the abdomen.

NEC diagnosis, however, remains challenging because many now see that Bell's staging criteria currently used for diagnosis as being not accurate.

Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample. Increase of neutrophil proportion just reflects the deterioration of the immune system, while decreased lymphocyte ratio reflects the increasing level of physical stress.

Further NLR is closely related to the inhibition of body's immune function. In a word, NLR could indicate the status of body's inflammation response and the level of physical stress timely and accurately.

In a clinical study conducted in 2001, the authors suggested the routine use of NLR as a stress factor in clinical ICU practice, and they claimed that NLR might has a prognostic and a predictive value of many diseases.

Gamma glutamyl transferase (GGT) is an enzyme found in the cell membranes of many tissues. The highest concentration is in the kidney, but the liver is considered the source of normal enzyme activity. GGT is involved in the transfer of amino acids across the cell membrane and also in leukotriene metabolism. It has an intracellular antioxidant effect because it is involved in glutathione metabolism, resulting in the formation of cysteine. GGT is cleared from the plasma by liver uptake.

Bilirubin is a free radical scavenger with anti-inflammatory and antioxidant property. One report described that stage III NEC had lower total serum bilirubin than their mild or disease-free controls during the first 14 days of life. Since serum bilirubin level is a function of the activity of UGT1A1, albumin binding, and the bilirubin load; it will be important to determine if serum bilirubin concentration correlates with NEC development or severity.

A relatively constant serum calcium (Ca2+) concentration is vital for cellular function and under strict control by the neural/humoral factors. It is unclear what causes serum Ca2+ lower in NEC neonates. In a recent report, higher level of serum GGT, a significantly lower serum bilirubin and Ca2+ were found in severe NEC.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Ain Shams University Faculty of Medicine

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

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates with gestational ages are between 28-36 weeks regardless of birth weight.

Description

Inclusion Criteria:

• Patient group: NEC preterm neonates with gestational ages are between 28-36 weeks regardless of birth weight. NEC diagnosis and staging will be according to Bell's staging criteria.

• Control group: Stable preterm neonate with matched gestational and postnatal ages without infectious diseases will be included.

Exclusion Criteria:

  • Neonates with congenital infectious diseases, perinatal asphyxia, severe birth defects, congenital digestive tract malformations, inherited metabolic diseases or parental refusal of enrollment.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient group
NEC preterm neonates with gestational ages are between 28-36 weeks regardless of birth weight. NEC diagnosis and staging will be according to Bell's staging criteria .
Diagnostic test: Serum γ-Glutamyl transferase (GGT), Total serum bilirubin (TSB), Serum calcium concentration (Ca2+), Peripheral blood neutrophil to lymphocyte ratio (NLR)
GGT, Ca2+, NLR and TSB are serum markers which had been studied for early detection and prediction of severity of NEC.
Control group
Stable preterm neonate with matched gestational and postnatal ages without infectious diseases.
Diagnostic test: Serum γ-Glutamyl transferase (GGT), Total serum bilirubin (TSB), Serum calcium concentration (Ca2+), Peripheral blood neutrophil to lymphocyte ratio (NLR)
GGT, Ca2+, NLR and TSB are serum markers which had been studied for early detection and prediction of severity of NEC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of some blood biomarkers as predictors of neonatal necrotizing enterocolitis.
Time Frame: Baseline
The peripheral blood neutrophil to lymphocyte ratio (NLR), serum levels of γ-Glutamyl transferase (GGT), total serum bilirubin and serum calcium (Ca2+) concentrations would been studied for early diagnosis and prediction of NEC severity and if found significant, scoring will be done according to their levels in different Bell's stages.
Baseline

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: Nehal El-Raggal, MD, Faculty of Medicine Ain Shams University
  • Study Director: Dina Essam, Faculty of Medicine Ain Shams University
  • Study Director: Azza Hassan, Faculty of Medicine Ain Shams University
  • Study Director: Yasser Wageih, Faculty of Medicine Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 15, 2019

Primary Completion (Actual)

December 15, 2019

Study Completion (Actual)

February 15, 2020

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • necrotizing enterocolitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

I can share my information as a researcher.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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