Ignite Creation Date:
2024-05-06 @ 2:18 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04277533
Status:
COMPLETED
Last Update Posted:
2020-08-27
First Post:
2020-02-18
Brief Title:
Predictors of Neonatal Necrotizing Enterocolitis
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Evaluation of Some Blood Biomarkers as Predictors of Neonatal Necrotizing Enterocolitis
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Bells stages
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 Bells 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 bodys immune function In a word NLR could indicate the status of bodys 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 neuralhumoral 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
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 Bells 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 bodys immune function In a word NLR could indicate the status of bodys 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 neuralhumoral 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None