NCT04140812

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

12 months

First QC Date

October 21, 2019

Last Update Submit

October 23, 2019

Conditions

Preterm BirthCoagulation Protein DisordersCoagulation Disorder Neonatal

Keywords

PretermCoagulationLC-MS/MSICHIVHNeonatal

Outcome Measures

Primary Outcomes (1)

  • 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)

Other Outcomes (8)

  • Composite mass spectrometric profile of coagulation and complement factors stratified by gestational week

    Single time point (1 day)

  • Composite mass spectrometric profile of coagulation and complement factors stratified by gender

    Single time point (1 day)

  • Composite mass spectrometric profile of coagulation and complement factors correlated to body weight

    Single time point (1 day)

  • +5 more other outcomes

Study Arms (2)

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).

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).

Diagnostic Test: mass spectrometry (LC-MS/MS)

Interventions

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.

Preterm infants (≤32+0 weeks)Term infants (≥37+0 weeks)

Eligibility Criteria

AgeUp to 72 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • medical indication (newborn screening) and informed consent for blood drawing

You may not qualify if:

  • clinical evidence of infection
  • clinical evidence of hyperbilirubinemia
  • Preeclampsia (PE), HELLP-syndrome, intrauterine growth restriction (IUGR) and PE+IUGR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics- and Adolescent Medicine, FAU Erlangen-Nuremberg

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Premature BirthCoagulation Protein DisordersThrombosis

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Fabian B Fahlbusch, M.D.

    Department for Children- and Adolescent Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fahlbusch

CONTACT

+49 9131 8533118fabian.fahlbusch@uk-erlangen.de

Ferdinand Knieling, M.D.

CONTACT

+49 9131 8533118ferdinand.knieling@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 28, 2019

Study Start

October 21, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

October 28, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)