SuspendedNot Applicable

HeartLight Pulse Study: Evaluation of Heart Rate Using an Electronic Stethoscope and Pre Placed ECG in the Delivery Room

Stopped: New data available in public domain requires re-evaluation of protocol.

United Kingdom50 participantsStarted 2016-05

Plain-language summary

This study will evaluate the accuracy of both an electronic stethoscope and electrocardiogram (ECG) to evaluate heart rate in neonatal patients in the delivery suite. The initial phase of this study will assess the electronic stethoscope use on stable neonates on the neonatal care prior to use in the delivery room.

Who can participate

Age range

4 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All must have written informed consent from the participant's mother * Phase 1: Any neonate requiring NICU admission and routine monitoring with ECG. * Phase 2: Preterm infants ≤32 weeks gestation delivered into a plastic bag/wrap Exclusion Criteria: * Phase 1: Infants undergoing comfort care (palliative care). Infants deemed too sick, as assessed by the clinical team caring for them, to tolerate additional procedures. This is unusual but would normally include infants who become more unstable with increased handling * Phase 2: Infants \>32 weeks gestation Infants where resuscitation is unlikely to be instigated (eg. known lethal condition)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heart rate

Timeframe: 10 minutes

Reliability of Pre placed ECG leads to measure heart rate

Timeframe: 30 minutes

Trial details

NCT IDNCT02747069

SponsorUniversity of Nottingham

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-12

View on ClinicalTrials.gov More Premature Birth trials