NCT06579157

Brief Summary

This study aims to explore the correlation between using ballistocardiography for monitoring respiration and heart rate in neonates under invasive and non-invasive respiratory support.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Nov 2024Jul 2027

First Submitted

Initial submission to the registry

August 27, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

August 27, 2024

Last Update Submit

February 25, 2026

Conditions

Bronchopulmonary Dysplasia

Keywords

newbornballistocardiographpressure sensorunobtrusive sensing

Outcome Measures

Primary Outcomes (1)

  • ballistocardiography waveform

    the correlation between using Ballistocardiography (BCG) for monitoring respiration and heart rate

    through study completion, an average of 2 weeks

Secondary Outcomes (1)

  • tidal volume

    through study completion, an average of 2 weeks

Interventions

Pressure-Sensing MattressesOTHER

using ballistocardiography (BCG) for monitoring respiration and heart rate in neonates

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

infant of Affiliated University Hospital

You may qualify if:

  • Using invasive ventilation support with flow sensors or non-invasive ventilation support
  • The legal representative signs the informed consent form

You may not qualify if:

  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ke-Yun Chao, PhD

    Fu Jen Catholic University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Yun Chao, PhD

CONTACT

+886905301879C00152@mail.fjuh.fju.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group leader of Respiratory Therapists

Study Record Dates

First Submitted

August 27, 2024

First Posted

August 30, 2024

Study Start

November 10, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)