Coagulation Disorder Neonatal, Coagulation Protein Disorders, Preterm Birth
Conditions
Keywords
Preterm, Coagulation, LC-MS/MS, ICH, IVH, Neonatal
Brief summary
This study aims to investigates the role of gestational age on the prevalence of coagulation factors and components of the complement system in preterm- (≤32+0 weeks) and term neonates (≥37+0 weeks) and their role for the development of brain hemorrhage.
Detailed description
The occurrence of brain hemorrhage (germinal matrix hemorrhage and intraventricular hemorrhage, GM-IVH) in newborns, especially in preterm infants, is one of the most important prognostic factors for mortality and morbidity (especially for later neurological development) in this collective. The risk of high-grade bleeding in extremely premature infants (22 weeks) is approx. 38% and decreases to approx. 7% by the 28th week. The total frequency of GM-IVH is around 8% in gestational weeks 23 to 31, with each additional gestational week reducing the risk by 3.5%. The etiopathology of brain hemorrhage is complex and involves both environmental and genetic factors. Recent studies particularly suggest an involvement of the immature coagulation system in preterm neonates. Global coagulation parameters, such as the International Normalized Ratio (INR), have already been associated with an increased risk of bleeding, but rarely show fluctuations outside the norm. Furthermore, polymorphisms in the area of individual coagulation factors as well as other inflammatory and vascular individual components of coagulation, are associated with an increased risk of bleeding. Mass spectrometry has long been used for the analysis of biological samples and has developed into an indispensable tool for proteomics research. The study aims to establish the mass spectrometric detection of a total of 125 blood plasma factors containing the individual components of the coagulation system and the complement system. The method enables quantitative detection of the coagulation system with even the smallest sample quantities, so that sampling can be combined with routine measures, particularly in the field of neonatology. This pilot study to compare the compositional differences regarding coagulation factors and the complement system in relation to the gestational age (i.e. preterm ≤32+0 weeks vs. term neonates ≥37+0 weeks).
Interventions
DIAGNOSTIC_TESTmass spectrometry (LC-MS/MS)
Blood collection (5 drops) during newborn-screening (36-72h after birth) or postnatal hospitalization (\<36h after birth). The blood sample will then be examined using mass spectrometry (LC-MS/MS) for 125 proteins.
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
Yes
Inclusion criteria
* medical indication (newborn screening) and informed consent for blood drawing
Exclusion criteria
* clinical evidence of infection * clinical evidence of hyperbilirubinemia * Preeclampsia (PE), HELLP-syndrome, intrauterine growth restriction (IUGR) and PE+IUGR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite mass spectrometric profile of coagulation and complement factors stratified by preterm/term neonates. | Single time point (1 day) | Individual composite mass spectrometric profile of 125 blood plasma factors containing the individual components of the coagulation system and the complement system of term (≥37+0 SSW) compared to preterm neonates (≤32+0 SSW) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Composite mass spectrometric profile of coagulation and complement factors stratified by gender | Single time point (1 day) | Individual composite mass spectrometric profile of 125 blood plasma factors containing the individual components of the coagulation system and the complement system of female compared to male neonates |
| Composite mass spectrometric profile of coagulation and complement factors correlated to body weight | Single time point (1 day) | Individual composite mass spectrometric profile of 125 blood plasma factors containing the individual components of the coagulation system and the complement system correlated to body weight |
| Composite mass spectrometric profile of coagulation and complement factors stratified by medication | Single time point (1 day) | Individual composite mass spectrometric profile of 125 blood plasma factors containing the individual components of the coagulation system and the complement system stratified by perinatal medication to non-perinatal medication. |
| Composite mass spectrometric profile of coagulation and complement factors stratified by gestational week | Single time point (1 day) | Individual composite mass spectrometric profile of 125 blood plasma factors containing the individual components of the coagulation system and the complement system stratified by gestational week |
| Mass spectrometric profile of coagulation and complement factors correlated to WBC | Single time point (1 day) | Individual composite mass spectrometric profile of 125 blood plasma factors containing the individual components of the coagulation system and the complement system correlated to leucocyte count (WBC) |
| Composite mass spectrometric profile of coagulation and complement factors correlated to maternal age | Single time point (1 day) | Individual composite mass spectrometric profile of 125 blood plasma factors containing the individual components of the coagulation system and the complement system correlated to maternal age |
| Composite mass spectrometric profile of coagulation and complement factors correlated to placental weight | Single time point (1 day) | Individual composite mass spectrometric profile of 125 blood plasma factors containing the individual components of the coagulation system and the complement system correlated to placental weight |
| Mass spectrometric profile of coagulation and complement factors correlated to CRP | Single time point (1 day) | Individual mass spectrometric profile of 125 blood plasma factors containing the individual components of the coagulation system and the complement system correlated to C-reaktive Protein (CRP) |
Countries
Germany
Contacts
Primary ContactFahlbusch
Backup ContactFerdinand Knieling, M.D.
Outcome results
None listed