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NCT03750266 Clinical Trial

3D Animation and Models to Aid Management of Fetal CDH

Congenital Diaphragmatic Hernia Clinical Trial

Official title:
The Role of 3D Images and Models to Aid Management of Cases of Congenital Diaphragmatic Hernia Diagnosed in the Antenatal Period. Consecutive Patients Studied From Diagnosis to Post Operative Period.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03750266
Other study ID # STH19783
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 4, 2017
Est. completion date June 30, 2025

Study information
Verified date April 2024
Source Sheffield Teaching Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH. This will both help the parents see what the problem is and also allow the surgeons, who will operate on the baby once it has been born, to see the size of the hole and what organs are in the wrong place.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Target Population: pregnancy women attending Jessop Wing Fetal medicine unit. - Accessible population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI. - Study population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI and agree to take part in the study. Exclusion Criteria: - Not able to give informed consent due to any reason including poor understanding of English - Under 18 years of age. - Unable to complete the fetal MRI process due to either metal implants or claustrophobia.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention data collected through routine scans
No intervention, we wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH.

Locations
Country Name City State
United Kingdom Jessop Wing Hospital Sheffield South Yorkshire

Sponsors (1)
Lead Sponsor Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient demographics Gestational age at time of scan and health outcomes from patient notes. This will be used to assess the accuracy of the 3D models developed. Baseline
See also
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Recruiting NCT02986087 - Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia N/A
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Active, not recruiting NCT05839340 - Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias N/A
Enrolling by invitation NCT05962346 - Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia N/A
Withdrawn NCT04186039 - Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations N/A
Unknown status NCT01302977 - Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial Phase 2
Recruiting NCT03179371 - Proteomic Profiling for Congenital Diaphragmatic Hernia
Recruiting NCT03138863 - Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO) N/A