Stratifying Risk for Intracerebral Haemorrhage

Preterm Birth Clinical Trial

— NEW_STRATEGI  

Official title:

STRATifying Risk for intracErebral haemorrhaGe and Neurodevelopmental DIsorders in Newborns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04140812
• Other study ID #: 294_19B
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2019
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Fahlbusch
• Phone: +49 9131 8533118
• Email: fabian.fahlbusch[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Cerebral Hemorrhage
• Coagulation Disorder Neonatal
• Coagulation Protein Disorders
• Disease
• Hemorrhage
• Hemostatic Disorders
• Premature Birth
• Preterm Birth

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Pediatrics- and Adolescent Medicine, FAU Erlangen-Nuremberg	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)