Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-30 @ 1:25 PM
Study NCT ID:
NCT07064356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-Powered Neonatal Risk Assessment for Improved Perinatal Outcomes
Sponsor:
FetalFirst Limited
Organization:
Study Overview
Official Title:
AI-Powered Neonatal Risk Assessment for Improved Perinatal Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
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:
None
Brief Summary:
This study aims to develop advanced artificial intelligence (AI) models that predict neonatal risks and complications based on historical multimodal health data, including ultrasound and MRI scans. The objective is to empower clinicians and provide clear, compassionate support for families navigating complex prenatal diagnoses.
Detailed Description:
The FetalFirst study employs observational, retrospective analysis utilizing DenseNet121 neural networks. It analyzes de-identified retrospective data comprising ultrasound images, MRI scans, and clinical documentation from existing medical records. This research has received ethical approval from Wales Research Ethics Committee (REC ref: 25/WA/0168, IRAS ID: 358793). Outcomes from this study are expected to significantly enhance clinical intervention strategies, offering healthcare professionals robust tools for earlier detection and improved management of congenital anomalies and neonatal risks. Additionally, the insights gained will provide critical support to parents facing high-risk pregnancies, assisting them in making informed decisions.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IRAS ID: 358793 | OTHER | Health Research Authority (HRA) - Wales REC | View |