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.
ID
Source
Brief title
Condition
- Other condition
- Neonatal and perinatal conditions
- Vascular hypertensive disorders
Synonym
Health condition
ECMO bij neonaten
Research involving
Sponsors and support
Intervention
Outcome measures
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.
The following parameters will be measured:
Left ventricle
Left ventricular dimensions: Left ventricular ejection fraction (LVEF)
Color-pooled Doppler (pulse wave): Mitral valve peak early diastolic flow
velocity (E), peak atrial flow velocity (A), right ventricular ejection time
(RVET).
Tissue Doppler imaging: peak systolic (S*), peak early diastolic (E*), and peak
atrial systolic (A*), isovolumetric relaxation time (IVRT*), isovolumetric
contraction time (IVCT*), duration of systole and diastole.
From these data, the following parameters are calculated: E*/A*, E/E*, systole*/
diastole*, and myocardial performance index (MPI).
2-D Speckle-tracking Echocardiography: left ventricle global longitudinal
strain (LV GLS), radial strain and circumferential strain, peak twist rate,
peak untwist rate.
Right ventricle:
Right ventricle dimensions: tricuspid valve annulus diameter, length,
anterio-inferior dimension, mid cavity diameter, fractional area change
(FAC-4ch), tricuspid annular plane systolic excursion (TAPSE).
Color-pooled Doppler (pulse wave): tricuspid valve peak early diastolic flow
velocity (E), peak atrial flow velocity (A), pulmonary artery acceleration time
(PAAT)
Tissue Doppler imaging: velocities (S*, E*, A*) and durations (ejection time,
diastole, systole, isovolumetric relaxation time (IVRT*), isovolumetric
contraction time (IVCT*).
2-D Speckle-tracking Echocardiography: peak longitudinal strain (pLS-4ch).
Secondary study parameters/endpoints (if applicable)
Secondary outcome
not applicable
Background 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.
Study 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 burden and risks
The risks for the newborn infant are negligible, since the echocardiographic
assessment is non-invasive and performed in a point-of-care setting.
Geert Grooteplein 10 (Rn 804)
Nijmegen 6500HB
NL
Geert Grooteplein 10 (Rn 804)
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
All neonates undergoing VA-ECMO and VV-ECMO in our ECMO center for the following diagnoses:
- Meconium aspiration syndrome
- Septicemia/pneumonia
- Congenital diaphragmatic hernia
- Idiopathic Pulmonary hypertension
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63370.091.17 |
| Other | NTR aangemeld |
| OMON | NL-OMON27732 |