Monitoring Key Activity and Physiology of Neonates in Int... | NCT04831242

Studies
Monitoring Key Activity and Physiology of Neonates in Intensive Care

NCT04831242

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Status

Recruiting

Last Update Posted

Apr 18, 2025Actual

Enrollment

48Estimated

Phase

Not provided

Conditions

Neonatal Seizure

Interventions

Not provided

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

Apr 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

Aug 1, 2021Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Apr 1, 2021

First Submission Date that Met QC Criteria

Apr 1, 2021

First Posted Date

Apr 5, 2021Actual

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

Apr 15, 2025

Last Update Posted Date

Apr 18, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kathryn Beardsall, Principle Investigator, Cambridge University Hospitals NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Cambridge University Hospitals NHS Foundation TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (NICU)

Detailed Description

To optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (NICU)

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

48Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Movement	cm	First week of life

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

written informed parental consent

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Newborn infants in neonatal intensive care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
kathryn beardsall	Contact	01223 746791		kb274@cam.ac.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Addenbrookes Hospital	Recruiting	Cambridge			United Kingdom