Clinical trial NCT04140812: Stratifying Risk for Intracerebral Haemorrhage
Official title: STRATifying Risk for intracErebral haemorrhaGe and Neurodevelopmental DIsorders in Newborns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Coagulation Protein Disorders
Coagulation Disorder Neonatal
Keywords: Preterm
Coagulation
LC-MS/MS
ICH
IVH
Neonatal
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 50
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: Composite mass spectrometric profile of coagulation and complement factors stratified by preterm/term neonates.
timeFrame: Single time point (1 day)
Secondary outcomes:
Other outcomes:
measure: Composite mass spectrometric profile of coagulation and complement factors stratified by gestational week
timeFrame: Single time point (1 day)
measure: Composite mass spectrometric profile of coagulation and complement factors stratified by gender
timeFrame: Single time point (1 day)
measure: Composite mass spectrometric profile of coagulation and complement factors correlated to body weight
timeFrame: Single time point (1 day)
measure: Composite mass spectrometric profile of coagulation and complement factors stratified by medication
timeFrame: Single time point (1 day)
measure: Mass spectrometric profile of coagulation and complement factors correlated to CRP
timeFrame: Single time point (1 day)
measure: Mass spectrometric profile of coagulation and complement factors correlated to WBC
timeFrame: Single time point (1 day)
measure: Composite mass spectrometric profile of coagulation and complement factors correlated to maternal age
timeFrame: Single time point (1 day)
measure: Composite mass spectrometric profile of coagulation and complement factors correlated to placental weight
timeFrame: Single time point (1 day)
Locations:
city: Erlangen
country: Germany
facility: Department of Pediatrics- and Adolescent Medicine, FAU Erlangen-Nuremberg
state: Bavaria
Study officials:
affiliation: Department for Children- and Adolescent Medicine
name: Fabian B Fahlbusch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: