AI-Powered Neonatal Risk Assessment for Improved Perinatal Outcomes

NCT ID: NCT07064356

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Congenital Anomalies Neonatal Complications Perinatal Outcomes Perinatal Outcomes of the Mother and Fetus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Retrospective Neonatal Data Cohort

This cohort consists of retrospective, anonymized neonatal health records, including ultrasound, MRI scans, and clinical documentation from previous cases, used to develop predictive AI models.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Historical, de-identified neonatal records including ultrasound images, MRI scans, and clinical documentation available for analysis.

Exclusion Criteria

* Cases with incomplete or missing critical data elements required for AI model analysis.
Minimum Eligible Age

1 Year

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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FetalFirst Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nawal (Nina) Abide, EMBA, MA, BA

Role: PRINCIPAL_INVESTIGATOR

FetalFirst Limited

Central Contacts

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Nawal (Nina) Abide, EMBA, MA, BA

Role: CONTACT

+447392477747

Related Links

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https://www.fetalfirst.com

FetalFirst Project Website

Other Identifiers

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IRAS ID: 358793

Identifier Type: OTHER

Identifier Source: secondary_id

FF-NN-AI-001

Identifier Type: -

Identifier Source: org_study_id

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