Ignite Creation Date:
2024-05-06 @ 4:18 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04947215
Status:
UNKNOWN
Last Update Posted:
2021-07-01
First Post:
2021-06-14
Brief Title:
The Association Between LPCAT1 Genetic Polymorphism and Stress Biomarkers in Neonatal Respiratory Distress Syndrome
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
The Association Between LPCAT1 Genetic Polymorphism and Stress Biomarkers in Neonatal Respiratory Distress Syndrome
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
RECRUITING
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:
Aims of the Research
Primary
1 Measure the levels of stress biomarkers in full and preterm neonates with normal and complicated pregnancies and to study the influence of delivery mode on their cord blood concentrations
2 Test the association between LPCAT1 genetic polymorphism and the levels of these biomarkers in neonates suffering from RDS
3 Study the relation between LPCAT1 genetic polymorphism and the riskseverity of neonatal respiratory distress syndrome
Secondary
1 Help understanding the possible etiology and pathogenesis of neonatal RDS 2 Help the possibility of early detection diagnosis and management
3 Help to decrease mortality and morbidity in selective cases 4 Understand the individual variability in the susceptibility to development of pulmonary pathologies
Primary
1 Measure the levels of stress biomarkers in full and preterm neonates with normal and complicated pregnancies and to study the influence of delivery mode on their cord blood concentrations
2 Test the association between LPCAT1 genetic polymorphism and the levels of these biomarkers in neonates suffering from RDS
3 Study the relation between LPCAT1 genetic polymorphism and the riskseverity of neonatal respiratory distress syndrome
Secondary
1 Help understanding the possible etiology and pathogenesis of neonatal RDS 2 Help the possibility of early detection diagnosis and management
3 Help to decrease mortality and morbidity in selective cases 4 Understand the individual variability in the susceptibility to development of pulmonary pathologies
Detailed Description:
Neonatal respiratory distress syndrome RDS is caused by lung immaturity and deficiency of lung surfactant and dysfunction in preterm newborns Surfactant is produced by type II pneumocyte that forms a bilayer of lipid over the inner surface of the alveoli Surfactant deficiency and dysfunction lead to increased alveolar surface tension which results in alveolar collapse and decreased lung aeration Respiratory distress syndrome is one of the main causes of neonatal mortality The risk of RDS increases with decreasing gestational age GA The incidence of RDS was estimated to be 90 in preterm neonates GA 28 weeks or below and to be 9 in full term neonates born at 38 weeks gestation Early diagnosis is very essential to optimize the treatment of infants with RDS
Pathogenesis The primary cause of RDS is deficiency andor dysfunction of surfactant which is a lipoprotein complex and is vital for normal lung function Surfactant is synthesized stored and secreted by the alveolar type II cells and is primarily composed of phospholipids which constitute 80-85 of the total mass The remaining components of surfactant includes neutral lipids 5-10 and proteins 10 Phosphatidylcholine PC the most abundant phospholipid species in surfactant constitutes 80 of the total phospholipids There are three key enzymes involved in the PC synthesis Lysophospholipid acyltransferase LPCAT1 Gene ID 79888 Cholinephosphotransferase CHPT1 Gene ID 56994 and Cholinephosphate cytidylyltransferase PCYT1B CPCT Gene ID 9468 LPCAT1 is the most important enzyme in biogenesis and a key enzyme in surfactant production LPCAT1 composed of 18 exons and is located on chromosome 5p1533 The study of the genetic polymorphisms of surfactant-lipids related gene provides significant data about individual variability in the susceptibility to development of respiratory distress syndrome
Neonatal stress biomarkers such as cardiac troponin CTn T CTnI NT-Terminal-pro-Brain Natriuretic Peptide NT-pro-BNP copeptin and high sensitivity C-reactive protein hs-CRPhave been considered as an indicator of perinatal asphyxia Troponin is an inhibitory protein complex located on the actin filament in all striated muscle and consists of three subunits T C and I The asphyxiated neonate has elevated levels of cardiac troponin I cTnI cTnI is thought to be also an indicator of perinatal asphyxia Neonates born after complicated delivery had significantly higher values of CTnT CTnI and Copeptin than those born after uncomplicated delivery The gender influence on copeptin releases The gestational age birth weight and duration of active labor and membrane rupture have significant effect on hs-CRP levels
Pathogenesis The primary cause of RDS is deficiency andor dysfunction of surfactant which is a lipoprotein complex and is vital for normal lung function Surfactant is synthesized stored and secreted by the alveolar type II cells and is primarily composed of phospholipids which constitute 80-85 of the total mass The remaining components of surfactant includes neutral lipids 5-10 and proteins 10 Phosphatidylcholine PC the most abundant phospholipid species in surfactant constitutes 80 of the total phospholipids There are three key enzymes involved in the PC synthesis Lysophospholipid acyltransferase LPCAT1 Gene ID 79888 Cholinephosphotransferase CHPT1 Gene ID 56994 and Cholinephosphate cytidylyltransferase PCYT1B CPCT Gene ID 9468 LPCAT1 is the most important enzyme in biogenesis and a key enzyme in surfactant production LPCAT1 composed of 18 exons and is located on chromosome 5p1533 The study of the genetic polymorphisms of surfactant-lipids related gene provides significant data about individual variability in the susceptibility to development of respiratory distress syndrome
Neonatal stress biomarkers such as cardiac troponin CTn T CTnI NT-Terminal-pro-Brain Natriuretic Peptide NT-pro-BNP copeptin and high sensitivity C-reactive protein hs-CRPhave been considered as an indicator of perinatal asphyxia Troponin is an inhibitory protein complex located on the actin filament in all striated muscle and consists of three subunits T C and I The asphyxiated neonate has elevated levels of cardiac troponin I cTnI cTnI is thought to be also an indicator of perinatal asphyxia Neonates born after complicated delivery had significantly higher values of CTnT CTnI and Copeptin than those born after uncomplicated delivery The gender influence on copeptin releases The gestational age birth weight and duration of active labor and membrane rupture have significant effect on hs-CRP levels
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