HeartLight Pulse Study
Research type
Research Study
Full title
Determination of heart rate in neonates on the NICU and delivery suite using ECG and electronic stethoscope, a feasibility study.
IRAS ID
190266
Contact name
Don Sharkey
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
The aims of this study are to:\n\n1) assess whether an electronic stethoscope can be accurately be used to measure a newborn’s heart rate (HR). At birth, a baby may require help to start breathing. Their response to treatment and subsequent further management is assessed by their HR, which is usually measured by counting the heart beats heard through a normal stethoscope but this is subject to human error. We hope that an electronic stethoscope could be a useful tool to assist the clinician in assessing HR accurately. \n\n2) assess whether pre placed ECG leads on a plastic bag/wrap can accurately measure HR and aid monitoring of newborn preterm babies. At birth, preterm babies are routinely placed in a plastic bag to help keep the baby warm. Due to their skin, which is often wet and sticky, ECG leads that are normally used on the neonatal intensive care unit to monitor HR will not easily stick easily. By placing the leads on the bag with a small amount of clinical conducting gel, we hope to overcome this problem and allow accurate detecting for the baby’s HR. \n\nOverall, we are aiming to establish if these devices and new techniques can be used at the time of delivery to improve assessment of the HR and guide management of the newborn more efficiently especially during resuscitation. \n\nThe study will be conducted at Nottingham University Hospital site on the neonatal unit and delivery suites over 24 months. Babies will be studied for up to 30 minutes.\n\nNeonates eligible for:\n-\tphase 1 are those on the neonatal unit with routine ECG and pulse oximetry monitoring.\n-\tphase 2 are newborn preterm <32 weeks \n\nWe hope that this work will provide early evidence of the benefit of these devices to help clinicians better monitor newborns requiring resuscitation at birth.\n
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
16/WM/0028
Date of REC Opinion
3 Feb 2016
REC opinion
Further Information Favourable Opinion