Preterm BirthNEW_STRATEGINCT04140812
Stratifying Risk for Intracerebral Haemorrhage
A study testing mass spectrometry (LC-MS/MS) in people with Preterm Birth and Coagulation Protein Disorders, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages Up to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Coagulation Protein Disorders, Coagulation Disorder Neonatal
- What is being tested?
- mass spectrometry (LC-MS/MS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 21 Oct 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- medical indication (newborn screening) and informed consent for blood drawing
Who cannot join
- clinical evidence of infection
- clinical evidence of hyperbilirubinemia
- Preeclampsia (PE), HELLP-syndrome, intrauterine growth restriction (IUGR) and PE+IUGR
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Pediatrics- and Adolescent Medicine, FAU Erlangen-Nuremberg
Erlangen, Bavaria, 91054
Fabian Fahlbusch, +49 9131 85 33118, fabian.fahlbusch@uk-erlangen.de
Ferdinand Knieling, +49 9131 85 33118, ferdinand.knieiling@uk-erlangen.de
About this study
Official title: STRATifying Risk for intracErebral haemorrhaGe and Neurodevelopmental DIsorders in Newborns
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.
Read the 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).
- Being tested
- mass spectrometry (LC-MS/MS)
- Keywords
- Preterm, Coagulation, LC-MS/MS, ICH, IVH, Neonatal
- Medical subject headings
- Premature Birth, Coagulation Protein Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mass spectrometry (LC-MS/MS)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Term infants (≥37+0 weeks) | Active comparator | 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). Receives: Diagnostic Test: mass spectrometry (LC-MS/MS) |
| Preterm infants (≤32+0 weeks) | Experimental | 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). Receives: Diagnostic Test: mass spectrometry (LC-MS/MS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Single time point (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start21 Oct 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabian B Fahlbusch, M.D., Principal investigator, Department for Children- and Adolescent Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140812
- Sponsor's protocol ID
- 294_19B
- Acronym
- NEW_STRATEGI
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRATifying Risk for intracErebral haemorrhaGe and Neurodevelopmental DIsorders in Newborns
- ClinicalTrials.gov ID
- NCT04140812
- Acronym / sponsor ID
- NEW_STRATEGI / 294_19B
- Keywords
- Preterm, Coagulation, LC-MS/MS, ICH, IVH, Neonatal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Term infants (≥37+0 weeks) | Active comparator | 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). |
| Preterm infants (≤32+0 weeks) | Experimental | 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). |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- medical indication (newborn screening) and informed consent for blood drawing
Key exclusion criteria (3 listed)
- clinical evidence of infection
- clinical evidence of hyperbilirubinemia
- Preeclampsia (PE), HELLP-syndrome, intrauterine growth restriction (IUGR) and PE+IUGR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Preterm infants (≤32+0 weeks), Term infants (≥37+0 weeks) |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabian B Fahlbusch, M.D. principal investigator
Department for Children- and Adolescent Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mass spectrometry (LC-MS/MS) in people with Preterm Birth and Coagulation Protein Disorders, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fahlbusch (+49 9131 8533118, fabian.fahlbusch@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite mass spectrometric profile of coagulation and complement factors stratified by preterm/term neonates. (time frame: Single time point (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.