Prospective observational cohort study to obtain more insight in heart function of neonates undergoing ECMO
ID
Bron
Verkorte titel
Aandoening
Echocardiography, neonate, ECMO, heart function, tissue doppler, deformation imaging
Ondersteuning
Maquet
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Prospective observational cohort study to obtain more insight in heart function of neonates undergoing ECMO
Onderzoeksopzet
Prior to, during, and after ECMO.
During ECMO serial scans will be performed.
Onderzoeksproduct en/of interventie
Echocardiography during ECMO
Publiek
Bart C.W. Kuipers
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
The Netherlands
+31 24 36 14 430
Bart.Kuipers@radboudumc.nl
Wetenschappelijk
Bart C.W. Kuipers
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
The Netherlands
+31 24 36 14 430
Bart.Kuipers@radboudumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Every neonate undergoing extracorporeal membrane oxygenation
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL6716 |
NTR-old | NTR6895 |
CCMO | NL63370.091.17 |
OMON | NL-OMON46379 |