Stratifying Risk for Intracerebral Haemorrhage
- Conditions
- Coagulation Protein DisordersPreterm BirthCoagulation Disorder Neonatal
- Interventions
- Diagnostic Test: mass spectrometry (LC-MS/MS)
- Registration Number
- NCT04140812
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- medical indication (newborn screening) and informed consent for blood drawing
- clinical evidence of infection
- clinical evidence of hyperbilirubinemia
- Preeclampsia (PE), HELLP-syndrome, intrauterine growth restriction (IUGR) and PE+IUGR
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preterm infants (≤32+0 weeks) mass 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). Term infants (≥37+0 weeks) mass 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).
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Pediatrics- and Adolescent Medicine, FAU Erlangen-Nuremberg
🇩🇪Erlangen, Bavaria, Germany