Stratifying Risk for Intracerebral Haemorrhage (NEW_STRATEGI)
Primary Purpose
Preterm Birth, Coagulation Protein Disorders, Coagulation Disorder Neonatal
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
mass spectrometry (LC-MS/MS)
Sponsored by
About this trial
This is an interventional diagnostic trial for Preterm Birth focused on measuring Preterm, Coagulation, LC-MS/MS, ICH, IVH, Neonatal
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
Sites / Locations
- Department of Pediatrics- and Adolescent Medicine, FAU Erlangen-NurembergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Term infants (≥37+0 weeks)
Preterm infants (≤32+0 weeks)
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04140812
First Posted
October 21, 2019
Last Updated
October 23, 2019
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT04140812
Brief Title
Stratifying Risk for Intracerebral Haemorrhage
Acronym
NEW_STRATEGI
Official Title
STRATifying Risk for intracErebral haemorrhaGe and Neurodevelopmental DIsorders in Newborns
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Coagulation Protein Disorders, Coagulation Disorder Neonatal
Keywords
Preterm, Coagulation, LC-MS/MS, ICH, IVH, Neonatal
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Term infants (≥37+0 weeks)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Preterm infants (≤32+0 weeks)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
mass spectrometry (LC-MS/MS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite mass spectrometric profile of coagulation and complement factors stratified by preterm/term neonates.
Description
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)
Time Frame
Single time point (1 day)
Other Pre-specified Outcome Measures:
Title
Composite mass spectrometric profile of coagulation and complement factors stratified by gestational week
Description
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
Time Frame
Single time point (1 day)
Title
Composite mass spectrometric profile of coagulation and complement factors stratified by gender
Description
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
Time Frame
Single time point (1 day)
Title
Composite mass spectrometric profile of coagulation and complement factors correlated to body weight
Description
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
Time Frame
Single time point (1 day)
Title
Composite mass spectrometric profile of coagulation and complement factors stratified by medication
Description
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.
Time Frame
Single time point (1 day)
Title
Mass spectrometric profile of coagulation and complement factors correlated to CRP
Description
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)
Time Frame
Single time point (1 day)
Title
Mass spectrometric profile of coagulation and complement factors correlated to WBC
Description
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)
Time Frame
Single time point (1 day)
Title
Composite mass spectrometric profile of coagulation and complement factors correlated to maternal age
Description
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
Time Frame
Single time point (1 day)
Title
Composite mass spectrometric profile of coagulation and complement factors correlated to placental weight
Description
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
Time Frame
Single time point (1 day)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fahlbusch
Phone
+49 9131 8533118
Email
fabian.fahlbusch@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Ferdinand Knieling, M.D.
Phone
+49 9131 8533118
Email
ferdinand.knieling@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabian B Fahlbusch, M.D.
Organizational Affiliation
Department for Children- and Adolescent Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics- and Adolescent Medicine, FAU Erlangen-Nuremberg
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabian Fahlbusch
Phone
+49 9131 85 33118
Email
fabian.fahlbusch@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Ferdinand Knieling
Phone
+49 9131 85 33118
Email
ferdinand.knieiling@uk-erlangen.de
12. IPD Sharing Statement
Plan to Share IPD
No
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Stratifying Risk for Intracerebral Haemorrhage
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