The aim of this pilot study, the *Ventilation, inflammation, perfusion and structure imaging in Neonatal Lung patients* (VINyL) study, is to develop a safe and fast MRI protocol for neonatal airway, lung and cardiac imaging in neonatal lung patients…
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is the technical qualitative assessment of the
MRIs.
Secondary outcome
Second, the ability of the MRI protocol to detect airway and lung ventilation,
inflammation, perfusion and structural changes. Third, the MRIs of prematurely
born infants will be compared to the MRIs of non- premature patients without
pulmonary disease. Lastly, the technical feasibility of MRI to detect cardiac
structures will be assessed and the MRI findings will be compared to the EIT
measurement.
Background summary
Bronchopulmonary dysplasia (BPD) is the most common respiratory disease in
prematurely born children, with an incidence of up to 75% in neonates with a
birthweight below 1000 grams. BPD is associated with increased risks of
neonatal respiratory, cardiac and neurological symptoms and persists into
childhood and adolescence. In our centre, BPD is currently monitored with lung
function and Computed Tomography(CT). However, these monitoring methods have
important downsides. For lung function, lung clearance index is only feasible
in approximately 30% of the patients and reliable spirometry measurement is
only possible from the age of 5 years onwards. CT is a sensitive technique to
depict lung structure, but it is limited by exposure to radiation, which
hampers its use for longitudinal follow up from early life onwards. Technical
developments in Magnetic Resonance Imaging(MRI) of airways and lungs are
quickly emerging, and have the potential to combine imaging of both lung
structure and function. The feasibility in BPD patients is not yet fully clear.
Study objective
The aim of this pilot study, the *Ventilation, inflammation, perfusion and
structure imaging in Neonatal Lung patients* (VINyL) study, is to develop a
safe and fast MRI protocol for neonatal airway, lung and cardiac imaging in
neonatal lung patients.
Study design
This prospective cross- sectional study will be performed at the Erasmus MC-
Sophia, and is a collaboration between the departments of Pediatrics, divisions
of Respiratory Medicine and Neonatology, and Radiology. After informed consent
all premature patients and non- premature patients will undergo thoracic MRI
and echocardiography and EIT measurement.
Study burden and risks
Participation in this study consist of an MRI at the Erasmus MC-Sophia, the MRI
protocol takes 45-60 minutes, furthermore an echocardiography will be included
for non-premature patients, taking 30 minutes, this is already clinical
protocol in premature patients. Lastly, an EIT measurment will take place which
takes 10 minutes.The study participants will not receive sedation, instead they
will be fed and swaddled, therefore half an hour preparation before the scan
will be necessary. MRI is a radiation free imaging method with minimal risk for
the patient. Moreover, we aim to use a noiseless high-resolution scan during
free-breathing, known as zero-TE (ZTE) or *silent MRI*. The only possible
adverse events are minimal chances of overstimulation or tiredness with
sometimes hemodynamic, respiratory or temperature instability. These events
will be overcome by providing a safe environment with feeding and swaddling (if
possible by the caregivers), appropriate noise protection, an MRI compatible
incubator with hemodynamic and respiratory control with the use of MRI
compatible equipment and guidance by neonatal resuscitation trained physicians/
nurses. A potential benefit for the patients will be that the radiological
results will be available for the treating physicians and might be used in
clinical care. The VINyL findings will improve our understanding of the
evolution and pulmonary and cardiac consequences of BPD in the neonatal phase.
BPD- MRI will eventually help us to improve the clinical care and treatment
options for this patient group. The development of a neonatal chest MRI
protocol will be a milestone in the campaign of dose reduction in paediatric
imaging.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Premature: born before 28 weeks PMA, good enough clinical condition to undergo
MRI, parents manage Dutch language, informed consent by parents, at 34-40 weeks
still admitted at the Sophia Children's Hospital, (at risk for) severe BPD
according to NHI criteria (received at least 28 days of oxygen)
Non premature: born after a minimum of 37 weeks PMA, good enough clinical
condition to undergo MRI, parents manage Dutch language, informed consent by
parents
Exclusion criteria
Premature: contraindication for MRI investigation
Non- premature: contraindicatie for MRI investigation, congenital
cardiovascular or pulmonary abnormalities, obtained mechanical ventilation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL70484.078.19 |
Other | NL7825 |