Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-7
SponsorBoston Children's Hospital
About this trial
Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery. The molecular mechanisms that are responsible for the clotting profile predisposing children to blood clots in the early stages of life are currently not well described.
The goal of this proposal is to prospectively collect plasma samples from ten (10) neonates with antenatal diagnosis of severe congenital heart disease (CHD) to better understand mechanisms responsible for abnormal clotting in the perioperative period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life
Disqualifiers
None
Trial population
All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Collecting discarded blood samples
Other interventionDiscarded blood samples will be collected from routine clinical labs collected before and after surgery.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Neonates with Congenital Heart Disease1 intervention
Trial outcomes
Primary outcomes
1
Characterization of microRNA in whole blood samples from neonates
isolation, purification and sequencing of patterns of miRNA and clustering analysis will be performed to determine predominant populations of miRNA related to inflammation, complement activation, and coagulation among other pathways
Time frame
2 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov