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Stratifying Risk for Intracerebral Haemorrhage (NEW_STRATEGI)

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ClinicalTrials.gov Identifier: NCT04140812
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Preterm Birth Coagulation Protein Disorders Coagulation Disorder Neonatal Diagnostic Test: mass spectrometry (LC-MS/MS) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: STRATifying Risk for intracErebral haemorrhaGe and Neurodevelopmental DIsorders in Newborns
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Term infants (≥37+0 weeks)
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).
Diagnostic Test: 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) for 125 proteins.

Experimental: Preterm infants (≤32+0 weeks)
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).
Diagnostic Test: 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) for 125 proteins.




Primary Outcome Measures :
  1. Composite mass spectrometric profile of coagulation and complement factors stratified by preterm/term neonates. [ Time Frame: 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 Outcome Measures:
  1. Composite mass spectrometric profile of coagulation and complement factors stratified by gestational week [ Time Frame: 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

  2. Composite mass spectrometric profile of coagulation and complement factors stratified by gender [ Time Frame: 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

  3. Composite mass spectrometric profile of coagulation and complement factors correlated to body weight [ Time Frame: 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

  4. Composite mass spectrometric profile of coagulation and complement factors stratified by medication [ Time Frame: 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.

  5. Mass spectrometric profile of coagulation and complement factors correlated to CRP [ Time Frame: 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)

  6. Mass spectrometric profile of coagulation and complement factors correlated to WBC [ Time Frame: 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)

  7. Composite mass spectrometric profile of coagulation and complement factors correlated to maternal age [ Time Frame: 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

  8. Composite mass spectrometric profile of coagulation and complement factors correlated to placental weight [ Time Frame: 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



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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140812


Contacts
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Contact: Fahlbusch +49 9131 8533118 fabian.fahlbusch@uk-erlangen.de
Contact: Ferdinand Knieling, M.D. +49 9131 8533118 ferdinand.knieling@uk-erlangen.de

Locations
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Germany
Department of Pediatrics- and Adolescent Medicine, FAU Erlangen-Nuremberg Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Fabian Fahlbusch    +49 9131 85 33118    fabian.fahlbusch@uk-erlangen.de   
Contact: Ferdinand Knieling    +49 9131 85 33118    ferdinand.knieiling@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Fabian B Fahlbusch, M.D. Department for Children- and Adolescent Medicine

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT04140812    
Other Study ID Numbers: 294_19B
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Preterm
Coagulation
LC-MS/MS
ICH
IVH
Neonatal
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Premature Birth
Hemostatic Disorders
Blood Coagulation Disorders
Coagulation Protein Disorders
Disease
Hemorrhage
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Lincomycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action