Conflict of Interest Declaration
The ILCOR Continuous Evidence Evaluation process is guided by a rigorous ILCOR Conflict of Interest policy. The following Task Force members and other authors were recused from the discussion as they declared a conflict of interest: None
The following Task Force member declared an intellectual conflict of interest and this was acknowledged and managed by the Task Force Chairs and Conflict of Interest committees: Vishal Kapadia has authored one of the studies included in the systematic review but did not participate in the decision to include the study or RoB assessment of the study.
CoSTR Citation
Kapadia VS, Kawakami MD, Strand M, Gately C, Costa-Nobre DT, Davis PG, de Almeida MF, El-Naggar W, Fabres JG, Fawke J, Finan E, Foglia EE, Guinsburg R, Hosono S, Isayama T, Kim HS, Madar RJ, McKinlay CJD, Nakwa FL, Perlman JM, Rabi Y, Roehr CC, Rüdiger M, Schmölzer GM, Sugiura T, Trevisanuto D, Weiner GM, Wyllie JP, Liley HG, Wyckoff MH. Methods of heart rate monitoring in the delivery room and neonatal outcomes (NLS #5201) [Internet] Brussels, Belgium. International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force, Available from http://ilcor.org
Methodological Preamble (and Link to Published Systematic Review)
The Delivery room (DR) heart rate (HR) monitoring question was last reviewed in 2015 {Perlman 2015 S207; Wyckoff 2020 S194}. The review’s focus was on assessing which method results in faster and more accurate HR assessment in the DR. Electrocardiogram (ECG) was compared with pulse oximeter or auscultation. While discussing this review, the ILCOR NLS Task force had noted that although ECG provides a more accurate heart rate in the first 3 minutes, there were no available data to determine how neonatal outcomes would change by acting on the information obtained by ECG. Some transient bradycardia may be normal and may be reflective of timing of cord clamping. On the other hand, fast and accurate HR assessment is critical for appropriate interventions in a timely manner. In addition, concerns were raised about the implications of a recommendation of HR monitoring device on resource-limited settings without a clear idea of cost-benefit ratio. The 2020 evidence update identified studies where the impact of delivery room HR monitoring method on neonatal outcomes was evaluated. Recognizing the need to systematically review the effect of DR HR monitoring method on neonatal outcomes, a new PICOST was created and it was prioritized by the Neonatal Life Support Task Force.
The continuous evidence prcess for the creation of Consensus of Science and Treatment Recommendations (CoSTR) started with a systematic review of heart rate monitoring in the delivery room to improve outcomes (PROSPERO 2021 CRD 42021283438) conducted by Vishal Kapadia, Mandira Daripa Kawakami, Marya Strand and Callum Gately. Evidence from neonatal literature was sought and considered by the Neonatal Life Support Task Force and clinical content experts. These data were taken into account when formulating the Treatment Recommendations.
Systematic Review
Kapadia VS, Kawakami MD, Strand M, Gately C, Perlman JM, Weiner GM, Liley HG, Wyckoff MH ; for the International Liaison Committee On Resuscitation Neonatal Life Support Task Force. Delivery room heart rate assessment methods to improve outcomes: a systematic review. To be submitted.
PICOST
The PICOST (Population, Intervention, Comparator, Outcome, Study Designs, and Time Frame)
Population: Newly born infants in the delivery room
Intervention: Use of ECG, Doppler device, digital stethoscope, photoplethysmography, video plethysmography, dry electrode technology or any other newer modalities
- Comparison: 1. Pulse oximeter with or without auscultation 2. Auscultation alone 3. In between intervention comparison
Outcomes: Duration of positive pressure ventilation (PPV) in delivery room from the start of PPV; tracheal intubation in delivery room; chest compressions or epinephrine (adrenaline) administration in delivery room; time from birth to heart rate ≥100 bpm as measured by ECG; resuscitation team performance in the delivery room; unanticipated admission to neonatal intensive care unit (as defined by authors); death before hospital discharge;
Outcomes ratings using the GRADE classifications of critical or important were based on a consensus for international neonatal resuscitation guidelines (range 1-3 low importance for decision-making, 4-6 important but not critical for decision-making, 7-9 critical for decision-making). {Strand 2020 328}
Potential subgroups were defined a priori: receipt of resuscitation (yes or no), gestational age (<28+0
weeks, 28+0-33+6 weeks, ≥34+ 0 weeks), cord management (early and delayed clamping, intact or cut cord milking).
Study Design: Randomized controlled trials (RCTs) and non-randomized studies (non-RCTs, interrupted time series, controlled before-and-after studies, and cohort studies) were eligible for inclusion. Unpublished studies (conference abstracts, trial protocols) and case series were excluded.
Timeframe: All years and all languages were included as long as there was an English abstract. The literature search was first done on October 29, 2021.
PROSPERO registration:
The review was registered with PROSPERO CRD 42021283438.
Risk of Bias:
The risk of bias (RoB) was assessed by outcome using Cochrane ROB2 {Sterne 2019 366} for RCTs and the ROBINS-I tool {Sterne 2016 355} for observational studies. Two RCTs were included. Both had an unclear risk of bias. One observational study was included which was determined to be at moderate risk of bias.
Consensus on Science
COMPARISON: ECG versus auscultation plus pulse oximeter
The systematic review identified 2 randomized controlled trials {Katheria 2017 6 and Abbey 2021 4} involving 91 neonates and 1 cohort study {Shah 2019 15} involving 632 neonates.
For the important outcome of duration of PPV from the start of PPV, the evidence of very low certainty (downgraded for risk of bias and serious imprecision) from 1 RCT involving 51 infants [Abbey 2021 4] could not exclude benefit or harm from use of ECG compared to use of auscultation plus pulse oximeter for heart rate assessment in the delivery room (mean difference 91 s, 95% CI -18 s to 200 s; p 0.1).
For the important outcome of time from birth to heart rate ≥100 bpm as measured by ECG, the evidence of very low certainty (downgraded for risk of bias and serious imprecision) from 1 RCT involving 51 infants [Abbey 2021 4] could not exclude benefit or harm from use of ECG compared to use of auscultation plus pulse oximeter for heart rate assessment in the delivery room (mean difference -21 s, 95% CI -78 s to 36 s; p 1.0).
For the important outcome of tracheal intubation in the delivery room, the evidence of low certainty (downgraded for risk of bias and imprecision) from 2 RCTs involving 91 infants {Katheria 2017 6 and Abbey 2021 4} could not exclude benefit or harm from use of ECG compared to use of auscultation plus pulse oximeter for heart rate assessment in the delivery room [RR 1.34, 95%CI 0.69-2.59; ARD 81 more DR intubations/1000 when using ECG in the DR (95% CI 74 fewer/1000 to 384 more/1000 delivery room tracheal intubation when using ECG in the DR)].
For the important outcome of tracheal intubation in the delivery room, the evidence of low certainty (downgraded for risk of bias and imprecision) from 1 observational study involving 632 infants {Shah 2019 15} suggests that use of ECG compared to use of auscultation plus pulse oximeter for heart rate assessment in the delivery room may reduce tracheal intubations in the delivery room [RR 0.75,95%CI 0.62-0.90; ARD 119 fewer delivery room intubations/1000 when using ECG in the delivery room (95% CI 181 fewer/1000 to 48 fewer/1000 delivery room tracheal intubation when using ECG in the delivery room)].
For the important outcome of chest compressions, evidence of very low certainty (downgraded for risk of bias and serious imprecision) from 2 randomized control trials {Katheria 2017 6 and Abbey 2021 4} involving 91 newborns could not exclude benefit or harm from use of ECG compared to use of auscultation plus pulse oximeter for heart rate assessment in the delivery room. As the event rate was zero, relative risk cannot be calculated.
For the important outcome of chest compressions, evidence of low certainty (downgraded for risk of bias and imprecision) from 1 observational study {Shah 2019 15} involving 632 newborns suggests that the use of ECG compared to auscultation plus pulse oximeter for heart rate assessment in the delivery room may increase or have little to no effect on number of infants receiving chest compressions in the delivery room [RR 2.14, 95%CI 0.98-4.70; ARD 35 more newborns receiving chest compressions per 1000 (1 fewer per 1000 to 113 more per 1000)].
For the important outcome of use of epinephrine (adrenaline) administration in the delivery room, evidence of very low certainty (downgraded for risk of bias and serious imprecision) from 2 randomized control trials {Katheria 2017 6 and Abbey 2021 4} involving 91 newborns could not exclude benefit or harm from use of ECG compared to use of auscultation plus pulse oximeter for heart rate assessment in the delivery room. As the event rate was zero, relative risk cannot be calculated.
For the important outcome of use of epinephrine (adrenaline) administration in the delivery room, evidence of low certainty (downgraded for risk of bias and imprecision) from 1 observational study {Shah 2019 15} involving 632 newborns could not exclude benefit or harm from use of ECG compared to use of auscultation plus pulse oximeter for heart rate assessment in the delivery room [RR 3.56, 95%CI 0.42-30.3; ARD 10 more newborns receiving epinephrine (adrenaline) per 1000 (2 fewer per 1000 to 111 more per 1000)].
For the critical outcome of death before discharge, evidence of very low certainty (downgraded for risk of bias and serious imprecision) from 1 randomized control trial {Abbey 2021 4} involving 51 newborns could not exclude benefit or harm from use of ECG compared to use of auscultation plus pulse oximeter for heart rate assessment in the delivery room [RR 0.96, 95%CI 0.15-6.31; ARD 3 fewer newborn deaths before discharge per 1000 (74 fewer per 1000 to 462 more per 1000)].
For the critical outcome of death before discharge, evidence of low certainty (downgraded for risk of bias and imprecision) from 1 observational study {Shah 2019 15} involving 632 newborns could not exclude benefit or harm from use of ECG compared to use of auscultation plus pulse oximeter for heart rate assessment in the delivery room [RR 0.96, 95%CI 0.57-1.61; ARD 3 fewer newborn deaths before discharge per 1000 (38 fewer per 1000 to 53 more per 1000)].
For the important outcomes of unanticipated admission to the neonatal intensive care unit and resuscitation team performance in the delivery room no data were reported in the included studies.
Subgroup Analyses:
No data were reported to perform subgroup analyses by receipt of resuscitation (yes or no), gestational age (<28+0 weeks, 28+0-33+6 weeks, ≥34+0 weeks) and cord management (early and delayed clamping or intact or cut cord milking).
Other Comparisons: We did not find any studies for Doppler device, digital stethoscope, photoplethysmography, video plethysmography, dry electrode technology or any other newer modalities versus pulse oximetry and/or auscultation. No studies were identified for in between intervention comparisons.
Treatment Recommendations
Where resources permit, we suggest that the use of ECG for heart rate assessment of a newly born infant requiring resuscitation in the delivery room is reasonable (weak recommendation, low certainty of evidence).
Where ECG is not available, auscultation with pulse oximetry is a reasonable alternative for heart rate assessment, but the limitations of these modalities should be kept in mind (weak recommendation, low certainty of evidence)
There is insufficient evidence to make a treatment recommendation regarding use of digital stethoscope, audible or visible Doppler ultrasound, dry electrode technology, reflectance-mode green light photoplethysmography or transcutaneous electromyography of the diaphragm for heart rate assessment of a newborn in the delivery room.
Auscultation with or without pulse oximetry should be used to confirm the heart rate when ECG is unavailable, not functioning or when pulseless electrical activity is suspected. (Good practice point)
Justification and Evidence to Decision Framework Highlights
In making these recommendations, the Neonatal Life Support Task Force acknowledges the following:
- Low certainty evidence from 3 studies informed this recommendation {Katheria 2017; Abbey 2021; Shah 2019}.
- Evidence from a recent ILCOR COSTR suggests that ECG does provide more rapid and more accurate assessment of heart rate in the delivery room than any of the alternative methods. However, it remains unclear if this level of speed and precision translates to clinically relevant differences in resuscitation interventions or clinical outcomes for newborn infants.
- One needs to balance the desire to have a rapid, continuous and accurate heart rate assessment in newly born infants needing resuscitation with the potential cost of ECG monitoring in the delivery room, especially in the face of lack of high-certainty data regarding clinical impact of routine ECG use for heart rate assessment in newly born infants in the delivery room. Individual councils should take into account the available resources, values and preferences while creating local guidelines for recommended modalities for HR assessment in the delivery room.
- Does use of ECG or other modalities for heart rate assessment improve neonatal outcomes (unanticipated admission to neonatal intensive care unit, death before hospital discharge, duration of PPV in delivery room from the start of PPV, tracheal intubation in delivery room, chest compressions or epinephrine (adrenaline) administration in the delivery room, time from birth to heart rate ≥100 bpm as measured by ECG)?
- Impact of ECG or other modalities for heart rate measurement on resuscitation team performance
- Impact of ECG and other modalities for heart rate assessment on equity
- Cost effectiveness of different modalities for heart rate assessment in the delivery room
- Heart rate assessment method in the delivery room for vigorous versus non-vigorous newly born infants
- HR assessment method for a subgroup of infants who require intubation and/or CPR in the delivery room
- HR assessment method for VLBW infants
- Prevalence of bradycardia in a newly born infant after the change in ILCOR recommendations for delayed cord clamping
- Prevalence of pulseless electrical activity for newly born infants in the DR
Knowledge Gaps
Attachments
NLS 5201 HR Monitoring Outcomes Et D
References
Abbey NV, et al. 2021 Electrocardiogram for heart rate evaluation during preterm resuscitation at birth: a randomized trial. Pediatr Res:1-7.
Dawson JA, et al. 2013 Comparison of heart rate and oxygen saturation measurements from Masimo and Nellcor pulse oximeters in newly born term infants. Acta Paediatrica 102:955-960.
Henry C, Shipley L, Ward C, Mirahmadi S, Liu C, Morgan S et al. Accurate neonatal heart rate monitoring using a new wireless, cap mounted device. Acta Paediatrica. 2020. 110(1), 72-78.
Iglesias B, et al. 2018 3-lead electrocardiogram is more reliable than pulse oximetry to detect bradycardia during stabilisation at birth of very preterm infants. Arch Dis Child Fetal Neonatal Ed 103:F233-F237.
Iglesias B, et al. 2016 [Pulse oximetry versus electrocardiogram for heart rate assessment during resuscitation of the preterm infant]. An Pediatr (Barc) 84:271-277.
Kamlin CO, et al. 2008 Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr 152:756-760.
Kamlin CO, O'Donnell CP, Everest NJ, Davis PG, Morley CJ 2006 Accuracy of clinical assessment of infant heart rate in the delivery room. Resuscitation 71:319-321.
Katheria A, et al. 2017 A pilot randomized controlled trial of EKG for neonatal resuscitation. PLoS One 12:e0187730.
Murphy MC, De Angelis L, McCarthy LK, O'Donnell CPF 2019 Randomised study comparing heart rate measurement in newly born infants using a monitor incorporating electrocardiogram and pulse oximeter versus pulse oximeter alone. Arch Dis Child Fetal Neonatal Ed 104:F547-F550.
Perlman JM, et al. 2015 Part 7: Neonatal resuscitation: 2015 international consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations. Circulation 132:S204-S241.
Shah BA, et al. 2019 Impact of electronic cardiac (ECG) monitoring on delivery room resuscitation and neonatal outcomes. Resuscitation 143:10-16.
Strand ML, Simon WM, Wyllie J, Wyckoff MH, Weiner G. Consensus outcome rating for international neonatal resuscitation guidelines. Arch Dis Child Fetal Neonatal. 2020;105(3):328-330. doi: 10.1136/archdischild-2019-316942
van Vonderen JJ, et al. 2015 Pulse oximetry measures a lower heart rate at birth compared with electrocardiography. J Pediatr 166:49-53.
Wyckoff, M. H. et al. Neonatal life support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Circulation 142, S185–S221 (2020).