CompletedNot Applicable

HeartLight: Heart Rate Monitoring for Newborn Resuscitation

United Kingdom184 participantsStarted 2016-03

Plain-language summary

This study will compare a newborn heart rate sensor (HeartLight) that is integrated into a hat with other common forms of heart rate monitoring such as electrocardiography (ECG), stethoscope and pulse oximetry (PO) in newborn babies. This will help to evaluate the new heart rate sensor's reliability and accuracy.

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: * Written consent from the mother * Realistic prospect of survival as determined by the attending clinical team Phase 1: \- Infants on NICU Phase 2: \- Infants on NICU requiring heart rate monitoring Phase 3: \- Newborn infants following non-emergency elective cesarean section Phase 4: \- Newborn infants who attending clinical team anticipate will require assessment of heart rate at time of birth Feedback: * Mothers of babies recruited into HeartLight study * Healthcare professionals exposed to the new device Exclusion Criteria: Phase 1+2: * Infants undergoing palliative care * Infants too sick to tolerate additional procedures Phase 3: * Abnormal antenatal scans suggesting significant fetal abnormality (by definition these are not routine pregnancies). * Any infant in whom resuscitation is likely to be required. * If multiple births then only the first baby born shall be recruited (due to resource limitations with researchers attending the birth) Phase 4: * Infants \<23 weeks * Infants that are not for active resuscitation as decided by the clinical team * If multiple births then only the first baby born shall be recruited (due to resource limitations with researchers attending the birth) Feedback: Unable to obtain written informed consent

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 acquisition time in the first minute of life

Timeframe: 1 hour

Trial details

NCT IDNCT02701920

SponsorUniversity of Nottingham

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-04

View on ClinicalTrials.gov More Infant, Newborn, Diseases trials