Status:
UNKNOWN
Measurement of Lung Area at Chest Radiography to Define the Prognosis in Newborns With CDH
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Congenital Diaphragmatic Hernia
Eligibility:
All Genders
1-24 years
Brief Summary
CDH represents a malformative disorder characterized by an incomplete diaphragm formation. This results in poor lung development (pulmonary hypoplasia), associated with altered vascularization of the ...
Detailed Description
The study period considered will be January 2012 - December 2018. From the medical record of each patient, the investigators will collect the following data: prenatal history, hernia severity, fetal e...
Eligibility Criteria
Inclusion
- Inborn and outborn patients admitted to the NICU within 24 hours after birth.
- Prenatal or postnatal (within 24 hours after birth) diagnosis of CDH.
- Preoperative chest radiograph performed for clinical purposes within 24 hours after birth in our NICU.
Exclusion
- Diagnosis of CDH made beyond 24 hours after birth
- Admission to the NICU beyond 24 hours after birth
- Preoperative chest radiograph performed beyond 24 hours after birth, rotated/asymmetric, with air leak (pneumothorax, pneumoperitoneum), not performed in our NICU or not accessible
- Early death (within 1 hour after birth)
Key Trial Info
Start Date :
July 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04396028
Start Date
July 9 2020
End Date
December 31 2021
Last Update
August 24 2021
Active Locations (1)
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1
Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, MI, Italy, 20129