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 applicable
The following Task Force members and other authors 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.
Task Force members Peter Davis and Jonathan Wyllie were coauthors on studies included in the systematic review but did not participate in discussion about inclusion or risk of bias assessment for these studies.
CoSTR Citation
Kawakami MD, Kapadia VS, 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 (NLS #5200)[Internet] Brussels, Belgium. International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force
Methodological Preamble and Link to Published Systematic Review
The Delivery room (DR) heart rate (HR) monitoring question was last reviewed in 2015 {Perlman 2015 S204, Wyckoff 2020 S185} 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 ECG provides a more accurate heart rate in the first 3 minutes. Fast and accurate HR assessment is critical for appropriate interventions in a timely manner, but 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 additional studies with newer methodologies such as digital stethoscope, photoplethysmography, video plethysmography, audible doppler, display doppler and dry electrode technologies available for use at the delivery room. This question was never put through GRADE analysis. In addition, accuracy of HR assessment was not examined. Recognizing the need to systematically review the methods for heart rate assessment in the delivery room, this PICOST was created and it was prioritized by the Neonatal Life Support Task Force.
The continuous evidence evaluation process for the production of Consensus on Science with Treatment Recommendations (CoSTR) started with a systematic review of HR assessment methods in the delivery room (PROSPERO 2021 CRD 42021283364) 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. Heart rate assessment methods in delivery room (diagnostic characteristics): a systematic review. To be submitted.
PICOST
The PICOST (Population, Intervention, Comparator, Outcome, Study Designs and Timeframe)
Population: Newly born infants in the DR
Intervention: Use of auscultation, palpation, pulse oximetry, Doppler device, digital stethoscope, photoplethysmography, video plethysmography, dry electrode technology or any other newer modalities
Comparators: 1. ECG
2. In between intervention comparison
Outcomes: Time for first HR assessment from the device placement, time for first HR assessment from birth and accuracy of HR assessment were ranked as important outcomes
For the purposes of this systematic review, ECG HR was considered the gold standard. Accuracy of HR assessment was examined using:
1. Pooled Bland-Altman analysis: The Bland-Altman plot is a method to quantify agreement between two quantitative measurements. {Bland 1995 1085, Bland 1999 135, Bland 1986 307, Giavarina 2015 141, Montenij 2016 750} This analysis was used to quantify agreement between ECG (reference technique) and other HR monitoring methods (experimental techniques). Bland–Altman (B-A) analysis determines the bias, or mean difference between the experimental and reference technique, as a measure of accuracy. B-A plot also includes limits of agreement (LoA), as a measure of precision. These statistical limits are calculated by using the mean difference (Bias) and the standard deviation(s) of the differences between two measurements. The LoA indicates the interval within which 95% of the differences between the two methods fall. If more than 1 study reported B-A plot analysis, we pooled that data together to create a summary estimate of accuracy and precision. The B-A plot method only defines the intervals of agreements, it does not say whether those limits are clinically acceptable or not. For this systematic review, agreement within +/- 10 bpm was considered acceptable. The B-A plot can also uncover whether the bias and differences are same or differ across various levels of HR.
2. Pooled sensitivity and specificity analysis to identify ECG HR < 100 bpm and ECG HR < 60 bpm.
The choices of outcomes were debated by the Task Force. Outcomes ratings using the GRADE classifications of critical, important or less 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), time epoch for the HR assessment (≤60 s, 61 s – 120 s, > 120 s)
Study Designs: Randomized controlled trials (RCTs) and non-randomized studies (non-randomized controlled trials, interrupted time series, controlled before-and-after studies, cohort studies) were eligible for inclusion.
Timeframe: All years and all languages were included as long as there was an English abstract; unpublished studies (e.g., conference abstracts, trial protocols) were excluded. The literature search was first done on October 29, 2021 and updated to August 5, 2022.
PROSPERO registration:
The review was registered with PROSPERO CRD 42021283364.
Consensus on Science
Comparison 1: Pulse oximeter (PO) with electrocardiogram (ECG)
The systematic review identified 3 RCTs {Abbey 2022 1445, Murphy 2019 F547, Murphy 2021 438} including 187 infants and 11 cohort studies {Bjorland 2020 175, Bobillo-Perez 2021 783, Bush 2021 550, Dawson 2013 955, Henry 2021 72, Iglesias 2018 F233, Iglesias 2016 271, Kamlin 2008 756, Katheria 2012 e1177, Mizumoto 2012 205, van Vonderen 2015 49} including 490 infants.
- Time for first HR assessment from the device placement:
A1: For the important outcome of time for first HR assessment from the device placement, PO was slower in presenting a HR signal than ECG (pooled difference HR from PO was 57 seconds (s) slower, 95% CI 13 s slower to 101 s slower, p<0.05), low certainty evidence downgraded for risk of bias and imprecision from 6 observational studies including 323 infants. {Bjorland 2020 175, Bush 2021 550, Iglesias 2018 F233, Iglesias 2016 271, Katheria 2012 e1177, van Vonderen 2015 49}
A2: For the important outcome of time for first HR assessment from the device placement, there was no significant difference between PO and ECG (pooled difference HR from PO 12 s slower, 95% CI 13 s faster to 38 s slower, p>0.05), very low certainty evidence downgraded for risk of bias, inconsistency and imprecision from 2 RCTs including 136 infants. {Murphy 2019 F547, Murphy 2021 438}
- Time for first heart rate assessment from birth
B1: For the important outcome of time for first HR assessment from birth, PO was slower than ECG (pooled difference HR from PO 52 s slower, 95% CI 9 s slower to 94 s slower, p<0.05), low certainty evidence downgraded for risk of bias and imprecision from 6 observational studies including 334 infants. {Bjorland 2020 175, Bobillo-Perez 2021 783, Dawson 2013 955, Kamlin 2006 319, Mizumoto 2012 205, van Vonderen 2015 49}
B2: For the important outcome of time for first HR assessment from birth, there was no significant difference between PO and ECG (pooled difference HR from PO 6 s slower, 95% CI 10 s faster to 23 s slower, p>0.05), low certainty evidence downgraded for risk of bias and imprecision from 2 RCTs including 87 infants. {Abbey 2022 1445, Murphy 2021 438}
- Accuracy of heart rate assessment: For this comparison, the index test was PO and the reference standard was ECG.
C1: One RCT {Abbey 2022 1445} and 4 cohort studies {Dawson 2013 955, Henry 2021 72, Kamlin 2008 756, van Vonderen 2015 49} assessed whether HR measured by PO (HRPO) agreed with HR measured by ECG (HRECG) by reporting average difference (mean bias) and LoA. This was graphically depicted by B-A plots in these studies. We meta-analyzed these data and calculated pooled mean difference (summary bias), LoA and the 95% confidence limit around LoA. This analysis showed that PO may be accurate but imprecise for HR estimation at birth (summary mean bias (HRPO – HRECG) -1.2 bpm; LoA: -17.9 to 15.5, 95% CI -32.8, 30.4), very low certainty evidence downgraded for risk of bias, inconsistency and imprecision from 28,211 observations in 218 infants. Thus, the average difference in the HR measured by PO and ECG in this population was small but 95% CI of LoA were very wide, indicating that at times, PO may underestimate or overestimate the HR substantially.
C2: For the identification of neonatal bradycardia (HRECG < 100 bpm) at birth, the pooled sensitivity of PO was 0.83 (95 % CI 0.76,0.88) and a pooled specificity was 0.97 (95 % CI 0.93,0.94), very low certainty evidence downgraded for risk of bias, inconsistency and imprecision from one RCT {Abbey 2022 1445} and 2 cohort studies {Iglesias 2018 F233, Kamlin 2008 756} enrolling 145 infants.
C3: For the identification of severe neonatal bradycardia (HRECG < 60 bpm) at birth, we could not calculate sensitivity and specificity as no studies reported these data.
Subgroup Analyses:
Receipt of Resuscitation: No studies reported data sufficient to perform this subgroup analysis. One study noted that there were slightly larger differences between HR measurements obtained from the PO and those from ECG when HRECG <100 bpm. {Dawson 2013 955}
Time epoch for heart rate assessment (≤60 s, 61 s – 120 s, > 120 s): No studies reported data sufficient to perform this subgroup analysis.
- One study noted that for the first 2 minutes after birth, measured HRPO values were significantly lower than HRECG. {van Vonderen 2015 49}
- Another study noted that PO displayed lower HR values compared to ECG during the first 6 minutes after birth. {Iglesias 2016 271}
Gestational age subgroups: No study provided sufficient data to perform this subgroup analysis. One study compared subgroups of infants of 29-32 and 32-35 weeks’ gestational age and found no difference between them in the time to HR display from the start of monitoring for either ECG or PO. {Murphy 2021 438}
Summary of evidence: PO is slower and imprecise for newborn HR assessment in the delivery room compared to ECG. PO may display lower heart rate values compared to ECG for the first 2 to 6 minutes after birth. There is limited evidence for HR assessment using PO vs ECG in extremely preterm newborns, newborns requiring resuscitation and newborns who have ECG HR< 100 bpm and < 60 bpm.
Comparison 2: Auscultation compared to ECG
The systematic review identified 5 observational studies including 171 infants. {Bobillo-Perez 2021 783, Cavallin 2020 88, Kamlin 2006 319, Murphy 2018 F490, Treston 2019 F227}
For the important outcome of time for first HR assessment from the device placement, there was no significant difference between auscultation and ECG (pooled difference HR by auscultation 4 s faster, 95% CI 10 s faster to 2 s slower, p > 0.05), moderate certainty evidence downgraded for risk of bias from 3 observational studies enrolling 105 infants. {Bobillo-Perez 2021 783, Murphy 2018 F490, Treston 2019 F227}
For the important outcome of time for first HR assessment from birth, auscultation detected HR faster than ECG at birth (pooled difference HR by auscultation 24 s faster, 95% CI 45 s faster to 2 s faster), low certainty evidence downgraded for risk of bias and imprecision from 3 observational studies enrolling 105 infants. {Bobillo-Perez 2021 783, Murphy 2018 F490, Treston 2019 F227} This was considered likely to be due to the time required for the placement of ECG leads and turning on the ECG monitor.
For the important outcome of accuracy of HR assessment, auscultation was accurate but imprecise (summary mean bias (HRAUSC – HRECG) was -9.9 bpm; LoA -32 to 12, 95% CI-217, 198), very low certainty evidence downgraded for risk of bias and imprecision from 3 observational studies including 91 infants. {Kamlin 2006 319, Murphy 2018 F490, Treston 2019 F227}
Subgroup Analyses:
For the pre-defined subgroup analyses by receipt of resuscitation and gestation, no data were available.
Time epoch for HR assessment (≤60 s, 61 s – 120 s, > 120 s): No studies reported data sufficient to fully perform this subgroup analysis. Some data were available to compare accuracy at 90 s vs 120 s after birth. These analyses showed very wide confidence intervals for the comparison of methods at both times, so the only conclusion that can be drawn is that auscultation was accurate but imprecise at both times.
For accuracy of HR assessment at 90 s, auscultation was accurate but imprecise (summary mean bias (HRAUSC – HRECG) -9.6 bpm; LoA -52 to 33 bpm, 95% CI -307, 203), very low certainty evidence downgraded for risk of bias and imprecision from 2 observational studies including 80 infants. {Bobillo-Perez 2021 783, Cavallin 2020 88}
For accuracy of HR assessment at 120 s, auscultation was accurate but imprecise (summary mean bias (HRAUSC – HRECG) – 0.4 bpm; LoA: -34 to 35 bpm, 95% CI -594, 189 bpm), very low certainty evidence downgraded for risk of bias and imprecision from 2 observational studies including 80 infants. {Bobillo-Perez 2021 783, Cavallin 2020 88}
Comparison 3: Palpation compared to ECG
The systematic review identified 2 observational studies including 86 infants. {Cavallin 2020 88, Kamlin 2006 319}
For the important outcome of time for first HR assessment from the device placement neither study reported this outcome.
For the important outcome of time for first HR assessment from birth neither study reported this outcome.
For the important outcome of accuracy of HR assessment, palpation was inaccurate and imprecise (mean bias of -21bpm with SD of 21 bpm), very low certainty evidence downgraded for risk of bias and applicability concerns from one observational study including 26 infants. {Kamlin 2006 319}
Subgroup analysis:
For the pre-defined subgroup analyses by receipt of resuscitation and gestational age, no data were available.
For accuracy of HR assessment by time epochs, palpation was similarly inaccurate and imprecise when assessed at 60 s, 90 s, 120 s and 300 s (mean difference between HR palpation and HR ECG of -20 bpm (LoA -80 to 40 bpm) at 60 s, -25 bpm (LoA -73 to 22 bpm) at 90 s, -23 bpm (LoA -67 to 20 bpm) at 120 s, and -31 bpm (LoA -96 to 34 bpm) at 300 s), very low certainty evidence downgraded for risk of bias and applicability concerns from one observational study including 60 infants. {Cavallin 2020 88}
Comparison 4: Palpation compared to auscultation
The systematic review identified 1 RCT including 60 infants {Owen 2004 213} and 1 observational study including 60 infants. {Cavallin 2020 88}
For the important outcome of time for first heart rate assessment from the device placement neither study reported this outcome.
For the important outcome of time for first heart rate assessment from birth neither study reported this outcome.
For the important outcome of accuracy of heart rate assessment, data were not available in a format that allowed calculation of a pooled summary estimate. {Owen 2004 213} The study authors noted that all palpation methods (femoral pulse, brachial pulse and umbilical cord pulse) showed very poor agreement with auscultated HR. {Owen 2004 213}
Comparison 5: Digital stethoscope compared to ECG
The systematic review identified 2 observational studies including 77 infants, {Gaertner 2017 F370, Treston 2019 F227} only one of which provided data assessing prespecified outcomes of the review. {Gaertner 2017 F370}
For the important outcome of time for first HR assessment from the device placement neither study reported this outcome.
For the important outcome of time for first HR assessment from birth neither study reported this outcome.
For the important outcome of accuracy of HR assessment, the digital stethoscope was accurate but imprecise (mean difference (HRDS –HRECG) of 0.2 bpm 95% CI −17.6 to 18 including crying periods and 1 bpm 95% CI −10.5 to 12.6 if excluding crying periods), very low certainty evidence downgraded for risk of bias and applicability concerns from 1 observational study including 37 infants. {Gaertner 2017 F370} The study authors found the digital stethoscope unreliable in detecting a signal during crying but suggested that since crying may be a sign of a successful transition, measurement of HR may not be necessary during crying.
Comparison 6: Doppler ultrasound (DU) compared to ECG
The systematic review identified 2 observational studies including 164 infants. {Agrawal 2021 2053, Shimabukuro 2017 1069}
For the important outcome of time for first heart rate assessment from the device placement neither study reported this outcome.
For the important outcome of time for first heart rate assessment from birth, DU was faster for presenting a HR signal than ECG (time to DU HR 76 s interquartile range (IQR) 51 s to 91 s vs ECG HR 96.5 s, IQR 74.2 s to 118 s, p<0.05), very low certainty evidence downgraded for severe risk of bias and applicability concerns from 1 observational study including 131 infants. {Agrawal 2021 2053}
For the important outcome of accuracy of heart rate assessment, DU (considered as index test) was accurate and precise compared to ECG (reference standard) (summary mean bias (HRDU – HRECG) was – 0.2 bpm; LoA -5 to 6, 95%CI -222, 223), very low certainty evidence downgraded for risk of bias, imprecision and applicability concerns from 2 observational studies including 164 infants. {Agrawal 2021 2053, Shimabukuro 2017 1069}
Comparison 7: Dry electrodes incorporated in a belt (DEB) compared to (conventional 3 lead) ECG
The systematic review identified 3 observational studies including 94 infants. {Bush 2021 550, Rettedal 2021 1092, van Twist 2022 1137}
For the important outcome of time for first HR assessment from the device placement, DEB was faster for presenting a HR signal than ECG (HRDEB at 22 s, IQR CI 13s to 45s, HRECG 171 s, IQR 129s to 239s), very low certainty evidence downgraded for risk of bias and imprecision from 1 observational study including 48 infants. {Rettedal 2021 1092}
For the important outcome of time for first HR assessment from birth, DEB was faster for presenting a HR signal than ECG (HRDEB 13 s IQR 10s to 18s, HRECG 42 s IQR 31 s to 63 s), very low certainty evidence downgraded for severe risk of bias and imprecision from 1 observational study including 28 infants. {Bush 2021 550}
For the important outcome of accuracy of HR assessment, DEB (considered as index test) was accurate and precise for HR estimation when compared to ECG (reference standard) (summary mean bias (HRDEE – HRECG) – 1.4 bpm; LoA -2.5 to 5.2, 95% CI -30, 33), very low certainty evidence downgraded for risk of bias and applicability concerns from 2 observational studies including 66 infants. {Rettedal 2021 1092, van Twist 2022 1137}
Treatment Recommendations
Where accurate heart rate estimation is needed at birth and resources permit, we suggest that the use of ECG for heart rate assessment of a newly born infant in the delivery room is reasonable. (Conditional recommendation, low certainty of evidence)
Pulse oximetry and auscultation may be reasonable alternatives for heart rate assessment, but the limitations of these modalities should be kept in mind. (Conditional 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 or any other newer modalities 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:
- The available data suggest that ECG provides a more rapid and accurate assessment of heart rate in the delivery room when compared to any other newer modalities, but the certainty of evidence is very low.
- Very few infants who had any of the following characteristics were included in these studies: those who were bradycardic, those requiring resuscitation as positive pressure ventilation, or extremely premature infants.
- Evidence from ILCOR CoSTR 5201 showed that it is unclear if the level of speed and accuracy/precision of HR estimation at birth translates to clinically relevant differences in resuscitation interventions, resuscitation team performance or clinical outcomes for newborn infants.
- Either auscultation or pulse oximetry or both have been commonly and routinely used for HR assessment in newborns at birth. In a resource limited setting, where ECG is not available, auscultation and/or pulse oximetry may serve as reasonable alternatives to ECG. HR estimation with these methods may be accurate but imprecise than ECG in the first few minutes after birth, especially in newborns who are bradycardic and are receiving resuscitation.
- Palpation for heart rate assessment at birth is inaccurate but certainty of evidence is very low.
- Dry electrode belt and Doppler US devices show good accuracy and speed for HR detection at birth. Larger studies which include extremely premature newborns and infants who are bradycardic and require resuscitation are needed.
- The cost-effectiveness and effects on equity of routine use of various HR assessment methods remain unclear. Some devices are likely to be unaffordable in low resource settings.
Knowledge Gaps
There were no studies identified that evaluated time to first HR assessment from device placement with newer modalities such as digital stethoscope, audible or visible Doppler ultrasound, reflectance-mode green light photoplethysmography or transcutaneous electromyography of the diaphragm in the delivery room.
There were no studies identified that evaluated time to first HR assessment from birth with newer modalities as digital stethoscope, reflectance-mode green light photoplethysmography or transcutaneous electromyography of the diaphragm in the delivery room.
Cost effectiveness of different modalities for HR assessment in the delivery room was not assessed by any study.
The impact of different HR assessment methods on resuscitation team performance, resuscitation interventions and neonatal clinical outcomes remains uncertain.
Should the HR assessment method in the delivery room be different for a vigorous vs non-vigorous newborn who does not respond to initial steps of resuscitation?
Should the HR assessment method in the delivery room be different for newly born infants in different gestational age (<28+0 weeks, 28+0-33+6 weeks, ≥34+ 0 weeks)?
HR monitoring methods should be evaluated in newborns who received resuscitation as positive pressure ventilation at birth and/or newborns with HRECG < 100 bpm or HRECG< 60 bpm.
Attachment: NLS 5200 HR Monitoring Diagnostic Et D
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