Clinical Need

About SurePulse

Every second counts

Around 1 in 10 babies are in need of some form of stabilisation at birth. The heart rate of the baby is critical for guiding the stabilisation or resuscitation process; however current monitoring methods do not always provide an early enough or sometimes an accurate enough heart rate. This can lead to uncertainty in the management of the baby’s care.

The scale of the problem

Up to 10% of newborn babies need some form of stabilisation or resuscitation at birth. This adds up to 80,000 babies a year in the UK, 400,000 babies across Europe, 500,000 in the US and 14 million babies worldwide.

Key challenges faced by clinicians

  • Pulse Oximetry significantly underestimates heart rate in the first 2 minutes after birth (Van Vonderen)
  • ECG is associated with skin injury and the electrodes are easily dislodged (Katheria). Also Pulseless Electrical Activity (PEA) may delay resuscitation (Johnson)
  • Stethoscope-assessed heart rates are inaccurate 36% of the time in the delivery room, 28% to the extent that inappropriate clinical decisions are indicated (Voogdt)

The clinical impact of the problem

Delayed resuscitation can have significant consequences: In 2017 there were 1,267 neonatal deaths in the UK, 68% of them between birth and 7 days. 119 of them were from Cardio-respiratory causes (MBRRACE 2019)

Newborn survival is improving (in developed countries) but long-term issues such as brain injury and chronic lung disease remain. Cerebral Palsy (CP) can be one of the consequences of birth trauma and there are 1,700 new cases of CP diagnosed in the UK each year. The prevalence of CP has not changed in 40 years. Neonatal hypoxia and encephalopathy remain major causes of CP:

The economic and resource consequences

Although the numbers of incidents are very small, poor outcomes associated with clinical negligence cost the NHS significant amounts each year – recent negligence claims for cerebral palsy average £9.9million per case (NHS Resolution)

There is a strong correlation between intensity of clinical intervention during resuscitation and Length of Stay in hospital (Bajaj). Reducing heart rate assessment error in the delivery room will support better care of newborn babies and save healthcare systems, like the NHS millions of pounds each year.

References

Wyllie, J., Ainsworth, S., & Tinnion, R. (2015). Resuscitation and support of transition of babies at birth. Retrieved from https://www.resus.org.uk/resuscitation-guidelines/resuscitation-and-support-of-transition-of-babies-at-birth/

AHA Neonatal Resuscitation Guidelines retrieved from https://eccguidelines.heart.org/circulation/cpr-ecc-guidelines/part-13-neonatal-resuscitation/

Voogdt, K., A. C Morrison, F. Wood, R. Elburg and J. P Wyllie (2010). “A randomised, simulated study assessing auscultation of heart rate at birth.” Resuscitation 81: 1000-1003.

van Vondren J et al “Pulse Oximetry Measures a Lower Heart Rate at Birth Compared with Electrocardiography” The Jnl of Pediatrics, 2014, http://dx.doi.org/10.1016/j.jpeds.2014.09.015

Iglesias, B et al. “Pulse oximetry versus electrocardiogram for heart rate assessment during resuscitation of the preterm infant”
An Pediatr (Barc). 2016;84(5):271-277

Dawson, J., G. Schmölzer and J. Wyllie (2018). “Monitoring heart rate in the delivery room.” Seminars in Fetal and Neonatal Medicine 23.

Odd DE, Lewis G, Whitelaw A, Gunnell D. Resuscitation at birth and cognition at 8 years of age: a cohort study. Lancet. 2009;373(9675):1615-22.

Moore T, Hennessy EM, Myles J, Johnson SJ, Draper ES, Costeloe KL, et al. Neurological and developmental outcome in extremely preterm children born in England in 1995 and 2006: the EPICure studies. BMJ. 2012;345:e7961.

ONS: Causes of neonatal deaths and stillbirths: a new hierarchical classification in ICD-10: retrieved from https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/methodologies/userguidetochildmortalitystatistics#coding-the-underlying-cause-of-death

Owen, J., Wyllie, P. “Determination of heart rate in the baby at birth.” Resuscitation 2004;60: 213-217.

NHS Resolution Annual Report and Accounts 2018-9 retrieved from https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/824330/NHS_resolution_annual_report_and_accounts_-_web_pdf.pdf

Bajaj, M., Natarajan, G. et al., Delivery Room Resuscitation and Short-Term Outcomes in Moderately Preterm Infants. J Pediatr, 195, 33-38 e32. doi:10.1016/j.jpeds.2017.11.039