3D Animation and Models to Aid Management of Fetal CDH | NCT03750266

Studies
3D Animation and Models to Aid Management of Fetal CDH

NCT03750266

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Status

Recruiting

Last Update Posted

May 16, 2025Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Congenital Diaphragmatic Hernia

Interventions

No intervention data collected through routine scans

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2017Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Aug 14, 2018

First Submission Date that Met QC Criteria

Nov 20, 2018

First Posted Date

Nov 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2025

Last Update Posted Date

May 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Congenital Diaphragmatic Hernia referred for fetal MRA			Other: No intervention data collected through routine scans

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention data collected through routine scans	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women whose fetus had a CDH and are referred to MRI.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jessop Wing Hospital	Recruiting	Sheffield	South Yorkshire	S10 2JF	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065630	Hernias, Diaphragmatic, Congenital

Ancestor Terms

ID	Term
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006548	Hernia, Diaphragmatic
D000082122	Internal Hernia

Browse Leaves

Not provided

Browse Branches

Not provided