Predictors of Neonatal Necrotizing Enterocolitis
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| ClinicalTrials.gov Identifier: NCT04277533 |
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Recruitment Status :
Completed
First Posted : February 20, 2020
Last Update Posted : August 27, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Necrotising Enterocolitis | Diagnostic Test: Serum γ-Glutamyl transferase (GGT), Total serum bilirubin (TSB), Serum calcium concentration (Ca2+), Peripheral blood neutrophil to lymphocyte ratio (NLR) |
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 |
| Actual Enrollment : | 50 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of Some Blood Biomarkers as Predictors of Neonatal Necrotizing Enterocolitis |
| Actual Study Start Date : | June 15, 2019 |
| Actual Primary Completion Date : | December 15, 2019 |
| Actual Study Completion Date : | February 15, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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 .
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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. |
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Control group
Stable preterm neonate with matched gestational and postnatal ages without infectious diseases.
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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. |
- 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.
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| Ages Eligible for Study: | 1 Day to 30 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04277533
| Egypt | |
| Ain Shams university Faculty of medicine | |
| Cairo, Egypt, 11591 | |
| 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 |
| Responsible Party: | Esraa Ragab Zaki, DR Esraa Ragab Zaki, Ain Shams University |
| ClinicalTrials.gov Identifier: | NCT04277533 |
| Other Study ID Numbers: |
necrotizing enterocolitis |
| First Posted: | February 20, 2020 Key Record Dates |
| Last Update Posted: | August 27, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | I can share my information as a researcher. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Calcium |
Bilirubin Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |