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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Term infants (≥37+0 weeks) | Active Comparator | 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). |
|
| Preterm infants (≤32+0 weeks) | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mass spectrometry (LC-MS/MS) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite mass spectrometric profile of coagulation and complement factors stratified by preterm/term neonates. | 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) | Single time point (1 day) |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite mass spectrometric profile of coagulation and complement factors stratified by gestational week | 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 | Single time point (1 day) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fahlbusch | Contact | +49 9131 8533118 | fabian.fahlbusch@uk-erlangen.de | |
| Ferdinand Knieling, M.D. | Contact | +49 9131 8533118 | ferdinand.knieling@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Fabian B Fahlbusch, M.D. | Department for Children- and Adolescent Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics- and Adolescent Medicine, FAU Erlangen-Nuremberg | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D020147 | Coagulation Protein Disorders |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Composite mass spectrometric profile of coagulation and complement factors stratified by gender |
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 |
| Single time point (1 day) |
| Composite mass spectrometric profile of coagulation and complement factors correlated to body weight | 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 | Single time point (1 day) |
| Composite mass spectrometric profile of coagulation and complement factors stratified by medication | 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. | Single time point (1 day) |
| Mass spectrometric profile of coagulation and complement factors correlated to CRP | 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) | Single time point (1 day) |
| Mass spectrometric profile of coagulation and complement factors correlated to WBC | 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) | Single time point (1 day) |
| Composite mass spectrometric profile of coagulation and complement factors correlated to maternal age | 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 | Single time point (1 day) |
| Composite mass spectrometric profile of coagulation and complement factors correlated to placental weight | 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 | Single time point (1 day) |
| D000091642 | Urogenital Diseases |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |