|- candidate number||28271|
|- NTR Number||NTR6895|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-nov-2017|
|- Secondary IDs||NL63370.091.17 |
|- Public Title||Echocardiographic-derived parameters of heart function in neonates undergoing extracorporeal membrane oxygenation|
|- Scientific Title||ECHocardiographic-derived parameters of heart function in neonates undergoing ecMO|
|- hypothesis||Prospective observational cohort study to obtain more insight in heart function of neonates undergoing ECMO|
|- Healt Condition(s) or Problem(s) studied||Echocardiography, ECMO, Heart function in neonates|
|- Inclusion criteria||Every neonate undergoing extracorporeal membrane oxygenation|
|- Exclusion criteria||- Gestational age < 34 completed weeks|
- Birth weight < 2000 grams
- Severe structural heart defect
- Pulmonary anomaly of which prognosis is known to be poor and considered irreversible
- Genetic or other major congenital or acquired abnormalities that are expected to be lethal on short notice
- Peri-/Intraventricular hemorrhage, ≥ grade II
- Severe pre-existent coagulopathy
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2018|
|- planned closingdate||1-jan-2020|
|- Target number of participants||15|
|- Interventions||Echocardiography during ECMO|
|- Primary outcome||The main study parameters are the generally used clinical and study related echocardiographic parameters of heart function arranged by left ventricle and right ventricle during systole and diastole using conventional, tissue Doppler, and deformation echocardiographic technologies. These parameters will be measured prior to, during, and after ECMO therapy. |
|- Secondary outcome||Conventional parameters of heart function|
|- Timepoints||Prior to, during, and after ECMO. |
During ECMO serial scans will be performed.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD Bart C.W. Kuipers|
|- CONTACT for SCIENTIFIC QUERIES||MD Bart C.W. Kuipers|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Maquet, Radboud University Medical Center Nijmegen|
|- Brief summary||Neonates undergoing extracorporeal membrane oxygenation (ECMO) are subjected to an invasive therapy that provides temporary mechanical cardiopulmonary support for various reasons. In these neonates, cardiac function is threatened because of existing persistent pulmonary hypertension of the newborn (PPHN). This can cause a right to left shunt through fetal channels and leads to an increased afterload of the right ventricle, decreased preload of the left ventricle, and due to underlying pulmonary diseases to decreased oxygen delivery to the myocardium. During this therapy, clinicians use different techniques of hemodynamic monitoring. Nowadays, in this patient population echocardiography is used as a subjective tool for assessing global cardiac function. There is no objective assessment of heart function. There is a paucity of data outlining the role of conventional and novel echocardiographic derived parameters of cardiac function in patients that undergo ECMO, especially in the pediatric and neonatal population. |
Objective: To describe serial changes in diastolic and systolic myocardial performance by comprehensive echocardiographic assessment in neonates prior to, during, and after ECMO treatment and relate this to the course of PPHN.
Study design: Prospective observational cohort study.
Study population: Neonates undergoing VA-ECMO and VV-ECMO in a level III university hospital.
Exclusion: structural heart defects and cardiomyopathy.
Main study parameters/endpoints: The main study parameters are the generally used clinical and study related echocardiographic parameters of heart function arranged by left ventricle and right ventricle during systole and diastole using conventional, tissue Doppler, and deformation echocardiographic technologies. These parameters will be measured prior to, during, and after ECMO therapy.
|- Main changes (audit trail)|
|- RECORD||28-nov-2017 - 29-dec-2017|