The aim of this study is to develop a safe and fast MRI protocol for the imaging of neonatal and pediatric BPD patients. This METC application addresses the first part of the MRI- BPD project: *Ventilation, Inflammation, perfusion and structure in…
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 ability of the MRI protocol to detect
structural lung changes related to BPD as established using the VIBE- scoring
system, evaluating normal lung tissue, low intensity regions, ventilation
defects, presence of airway wall thickening, consolidations and severity of
architectural distortion.
Secondary outcome
A technical qualitative assessment of the MRIs will be done. The MRI findings
will be correlated to spirometry data, MBW measurements and compared to the CT
findings.
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 respiratory, cardiac and
neurological symptoms and can evolve into chronic lung disease during childhood
and adolescence. BPD is currently monitored with spirometry and Computed
Tomography (CT). However, these monitoring methods have important downsides.
Reliable spirometry measurement is not possible until the age of 5 years and
spirometry outcomes have a poor sensitivity for changes in lung structure. CT
is a sensitive technique to depict lung structure, but it has an important
limitation due to exposure to radiation, which hampers its use for long term
follow up and for evaluating combined structure-function information. Recent
technical developments in pulmonary Magnetic Resonance Imaging (MRI) show
promising results for safe and extensive combined imaging of structure and
function in neonatal and pediatric BPD patients.
Study objective
The aim of this study is to develop a safe and fast MRI protocol for the
imaging of neonatal and pediatric BPD patients. This METC application addresses
the first part of the MRI- BPD project: *Ventilation, Inflammation, perfusion
and structure in pediatric Bronchopulmonary dysplasia Erasmus*: VIBE study, the
development of a pediatric BPD protocol. We will use MRI to image the lungs of
pediatric BPD patients and evaluate these images on ventilation, inflammation,
perfusion and structural changes.
Study design
This study is a prospective cross-sectional study performed at the Erasmus MC-
Sophia Children*s Hospital, The Netherlands and is a collaboration between the
departments of pediatric pulmonology, neonatology and radiology. After informed
consent, all patients and volunteers will undergo spirometry, multiple breath
washout (MBW) measurement and the MRI protocol.
Study burden and risks
Participation in this study consists of a three-hours visit to the Sophia
Children*s Hospital. This visit will consist of a physical examination (10
minutes), spirometry and instructions for the spirometry-controlled MRI (30
minutes), MBW measurement (20 minutes), training in a dummy MRI (15 minutes)
and the MRI protocol (30-45 minutes). If applicable and possible in the
radiology planning and if requested by parents/patient the clinically ordered
pulmonary CT scan can be planned on the same day. None of these procedures are
associated with a direct risk for the patient. Nitrogen MBW is a safe
technique, without risk for the children. MRI is a radiation free technique
without risk for the children. The only adverse effect is related to the noisy
and restricted environment of the MRI scanner that can induce claustrophobia.
Appropriate training will be performed to minimize the risk for claustrophobia,
and each subject will have the opportunity to withdraw from the study at any
moment of the study. A benefit for the patients will be that the data obtained
from the MRI, spirometry and MBW measurement will be available for the treating
physician to be used for clinical treatment. This VIBE study is the first phase
of the development of a neonatal and pediatric BPD-MRI protocol, for the
clinical follow up of all BPD patients. The VIBE findings will improve our
understanding of the long term pulmonary consequences in BPD patients. BPD- MRI
will eventually help us to improve the clinical care and treatment options for
this patient group.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Patients: diagnosis of BPD according to NHI criteria, age between 6 and 16
years, (in half of the BPD patients,n<=6) routine clinical CT scan planned in
the next six months or received a clinically ordered spirometry controlled CT
in the past six months, informed consent by parents/patient, Premature- non BPD
volunteers: age between 6 and 16 years, born <32 weeks of gestation, informed
consent by parents/patient, Healthy volunteers: age between 6 and 16 years,
informed consent by parents/patient
Exclusion criteria
Patients: contra- indications for MRI, inability to follow instructions in the
MRI, current severe lung infection (respiratory distress, severe coughing,
antibiotic use for lung infection), chronic oxygen need, Premature non- BPD
patients: contra- indications for MRI, inability to follow instructions in the
MRI, current severe lung infection (respiratory distress, severe coughing,
antibiotic use for lung infection), chronic oxygen need, diagnosis of BPD,
Healthy volunteers: contra- indications for MRI, inability to follow
instructions in the MRI, current severe lung infection (respiratory distress,
severe coughing, antibiotic use for lung infection), chronic oxygen need, born
at a gestational age of less than 37 weeks, presence of pulmonary comorbidities
(asthma, cystic fibrosis, interstitial lung disease etc.)
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 | NL66451.078.18 |