Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2025-12-17 @ 7:09 AM
Study NCT ID:
NCT04609163
Status:
None
Last Update Posted:
2024-11-12 00:00:00
First Post:
2020-10-20 00:00:00
Brief Title:
Machine and Deep Learning for Congenital Diaphragmatic Hernia (CLANNISH)
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study Overview
Official Title:
A Machine Learning Approach to Predict Pulmonary Hypertension in Newborns With Congenital Diaphragmatic Hernia: a Pilot Study
Status:
None
Status Verified Date:
2024-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLANNISH
Brief Summary:
The investigators will collect clinical and instrumental data regarding prenatal history as well as the medical and surgical postnatal course. In particular, the investigators will record data from a prenatal ultrasound performed between 25+0 and 30+6 weeks of gestation (before "Fetoscopic Endotracheal Occlusion" (FETO) procedure, in case of prenatal treatment): estimated fetal weight (EFW), amniotic fluid, Doppler velocimetry of umbilical artery, defect side, herniated organs, observed/expected lung-to-head ratio tracing (O/E LHR%), grading of hernia severity, Doppler velocimetry of contralateral pulmonary artery. Gestational age at diagnosis, details about FETO procedure, and the course of pregnancy will be also recorded.
On fetal MRI, the investigators will calculate: observed/expected total fetal lung volume (O/E TFLV%), percentage of liver herniation (%LH), signal intensity of lung and liver on T2 sequences, mediastinal shift angle, apparent diffusion coefficient (ADC) on diffusion-weighted sequences (DWI).
The radiographic pulmonary area will be calculated on digital chest x-ray performed within 24 hours after birth, by tracing the perimeter of the lung outlined by the rib cage and the diaphragm, excluding the mediastinal structures and the herniated organs.
Regarding the neonatal course, the investigators will focus on pulmonary hypertensive status, need for ECMO, and deaths. In particular, pulmonary hypertension will be evaluated based on clinical parameters (such as systemic pressure, heart rate, oxygen saturation, and oxygen supplementation, inotropic drugs, vasopressors, pulmonary vasodilators) as well as echocardiographic parameters (systolic pulmonary artery pressure (PAPs) from tricuspid valve regurgitation, mean pulmonary artery pressure from pulmonary valve regurgitation, pulmonary artery flow, characteristics of the interventricular sept, shunts, cardiac anomalies). Echocardiograms in our NICU are performed bedside throughout the hospital stay. The investigators will consider one exam per day from birth to 48 hours after surgery, one exam per week in the following 4 weeks, one exam per months until discharge. Other relevant data, like neurologic complications, metabolic disorders or infections, will be recorded as well.
Finally, the investigators will record data regarding the surgical course: day of intervention, type of surgical repair, use of patch, intra- or post-operative complications.
On fetal MRI, the investigators will calculate: observed/expected total fetal lung volume (O/E TFLV%), percentage of liver herniation (%LH), signal intensity of lung and liver on T2 sequences, mediastinal shift angle, apparent diffusion coefficient (ADC) on diffusion-weighted sequences (DWI).
The radiographic pulmonary area will be calculated on digital chest x-ray performed within 24 hours after birth, by tracing the perimeter of the lung outlined by the rib cage and the diaphragm, excluding the mediastinal structures and the herniated organs.
Regarding the neonatal course, the investigators will focus on pulmonary hypertensive status, need for ECMO, and deaths. In particular, pulmonary hypertension will be evaluated based on clinical parameters (such as systemic pressure, heart rate, oxygen saturation, and oxygen supplementation, inotropic drugs, vasopressors, pulmonary vasodilators) as well as echocardiographic parameters (systolic pulmonary artery pressure (PAPs) from tricuspid valve regurgitation, mean pulmonary artery pressure from pulmonary valve regurgitation, pulmonary artery flow, characteristics of the interventricular sept, shunts, cardiac anomalies). Echocardiograms in our NICU are performed bedside throughout the hospital stay. The investigators will consider one exam per day from birth to 48 hours after surgery, one exam per week in the following 4 weeks, one exam per months until discharge. Other relevant data, like neurologic complications, metabolic disorders or infections, will be recorded as well.
Finally, the investigators will record data regarding the surgical course: day of intervention, type of surgical repair, use of patch, intra- or post-operative complications.
Detailed Description:
The investigators will collect clinical and instrumental data regarding prenatal history as well as the medical and surgical postnatal course In particular the investigators will record data from a prenatal ultrasound performed between 250 and 306 weeks of gestation before Fetoscopic Endotracheal Occlusion FETO procedure in case of prenatal treatment estimated fetal weight EFW amniotic fluid Doppler velocimetry of umbilical artery defect side herniated organs observedexpected lung-to-head ratio tracing OE LHR grading of hernia severity Doppler velocimetry of contralateral pulmonary artery Gestational age at diagnosis details about FETO procedure and the course of pregnancy will be also recorded
On fetal MRI the investigators will calculate observedexpected total fetal lung volume OE TFLV percentage of liver herniation LH signal intensity of lung and liver on T2 sequences mediastinal shift angle apparent diffusion coefficient ADC on diffusion-weighted sequences DWI
The radiographic pulmonary area will be calculated on digital chest x-ray performed within 24 hours after birth by tracing the perimeter of the lung outlined by the rib cage and the diaphragm excluding the mediastinal structures and the herniated organs
Regarding the neonatal course the investigators will focus on pulmonary hypertensive status need for ECMO and deaths In particular pulmonary hypertension will be evaluated based on clinical parameters such as systemic pressure heart rate oxygen saturation and oxygen supplementation inotropic drugs vasopressors pulmonary vasodilators as well as echocardiographic parameters systolic pulmonary artery pressure PAPs from tricuspid valve regurgitation mean pulmonary artery pressure from pulmonary valve regurgitation pulmonary artery flow characteristics of the interventricular sept shunts cardiac anomalies Echocardiograms in our NICU are performed bedside throughout the hospital stay The investigators will consider one exam per day from birth to 48 hours after surgery one exam per week in the following 4 weeks one exam per months until discharge Other relevant data like neurologic complications metabolic disorders or infections will be recorded as well
Finally the investigators will record data regarding the surgical course day of intervention type of surgical repair use of patch intra- or post-operative complications
On fetal MRI the investigators will calculate observedexpected total fetal lung volume OE TFLV percentage of liver herniation LH signal intensity of lung and liver on T2 sequences mediastinal shift angle apparent diffusion coefficient ADC on diffusion-weighted sequences DWI
The radiographic pulmonary area will be calculated on digital chest x-ray performed within 24 hours after birth by tracing the perimeter of the lung outlined by the rib cage and the diaphragm excluding the mediastinal structures and the herniated organs
Regarding the neonatal course the investigators will focus on pulmonary hypertensive status need for ECMO and deaths In particular pulmonary hypertension will be evaluated based on clinical parameters such as systemic pressure heart rate oxygen saturation and oxygen supplementation inotropic drugs vasopressors pulmonary vasodilators as well as echocardiographic parameters systolic pulmonary artery pressure PAPs from tricuspid valve regurgitation mean pulmonary artery pressure from pulmonary valve regurgitation pulmonary artery flow characteristics of the interventricular sept shunts cardiac anomalies Echocardiograms in our NICU are performed bedside throughout the hospital stay The investigators will consider one exam per day from birth to 48 hours after surgery one exam per week in the following 4 weeks one exam per months until discharge Other relevant data like neurologic complications metabolic disorders or infections will be recorded as well
Finally the investigators will record data regarding the surgical course day of intervention type of surgical repair use of patch intra- or post-operative complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None