The first minutes, hours, and days are critical after a difficult birth. There are multiple guidelines that govern care to help you protect your smallest patients, identify challenges, or recognize complications before they occur. Many of these guidelines require accurate heart rate and SpO2 values — and pulse oximetry provides both. Rely on Nellcor™ pulse oximetry to provide accurate data for key neonatal guidelines including:
Neonatal Resuscitation Program (NRP) guidelines begin with the basic considerations normal in any delivery: gestation period, muscle tone, color, normal breathing, and healthy crying. SpO2 monitoring is needed when any of these signs is abnormal or alarming and if stimulation and airway clearing don’t quickly resolve the issues.1
Timely, accurate information can help you determine the right intervention to help a newborn transition to normal respiration and avoid unnecessary interventions.
Visual assessments alone may not be accurate enough to determine resuscitation needs. However, pulse oximetry monitoring at one-minute intervals for several minutes helps you determine whether the baby is within the target preductal SpO2 range. Or it can show if supplemental oxygen is needed.1
Speedy interventions depend, in part, on how quickly pulse oximeters post results.
1 minute |
60% - 65% |
---|---|
2 minutes |
65% - 70% |
3 minutes |
70% - 75% |
4 minutes |
75% - 80% |
5 minutes |
80% - 85% |
10 minutes |
85% - 95% |
Note: Three methods of sensor application were applied in these two studies (same process in both). Our IFU recommendations are for the third method of application. In this scenario, comparing the timing to accurate post across both papers, the Nellcor™ pulse oximetry system posted accurately faster than the Masimo system.
If there is respiratory difficulty and low heart rate, delivery room resuscitation might require positive-pressure ventilation (PPV), which presents both benefits and risks.4 Accurate monitoring will show when and how long to administer PPV.
PPV is a major intervention requiring post-resuscitation care and observation, and the decision to begin PPV depends on accurate information.
Infants who receive prolonged PPV are more likely to have morbidities and require special neonatal care.5 Therefore, pulse oximetry must indicate exactly when interventions achieve target SpO2 levels to help avoid adverse effects. Preterm infants are particularly at risk for chronic lung disease (CLD) and retinopathy of prematurity (ROP) resulting from excess oxygen exposure.6
Heart rate is important for guiding interventions. NRP guidelines caution against a possible tendency for slower or underestimated heart rate readings from pulse oximeters when compared to ECG.1 However, newer generation pulse oximeters are more reliable and may be useful for in measuring both SpO2 and heart rate.3
Read MoreDelayed diagnosis of CCHD can result in infant death or injury.9 Adding pulse oximetry to newborn assessments can enhance the clinician's detection of CCHD better than assessments like prenatal ultrasounds which failed to detect a significant number of cases.8 Today, CCHD screenings rely heavily on accurate SpO2 readings with pulse oximetry.
Nellcor™ pulse oximetry monitoring offers measurements you can count on to help you avoid false negatives and missed diagnoses.
A passed screen relies on less than a three percent variance between hand and foot readings. So, pulse oximeters used in monitoring must demonstrate high levels of sensitivity and specificity.10
The pulse oximeter should also be designed to overcome challenges such as infant motion to ensure accurate readings. Therefore, guidelines recommend screens be performed with pulse oximeters that: 11
are motion tolerant
report functional oxygen saturation
have been cleared by the FDA for use in newborns
have an accuracy of ± two percent
Requirements for CCHD Screening |
|||
---|---|---|---|
Nellcor™ Pulse Oximetry Sensor* |
Stryker Reprocessed Sensor13 |
ConMed Dolphin Sensor14 |
|
Neonatal accuracy of ±2% |
✔ |
✖ |
✖ |
Motion tolerant pulse oximeter |
✔ |
✖ |
✖ |
Reports functional oxygen saturation |
✔ |
✔ |
✔ |
Validated in low perfusion conditions |
✔ |
✖ |
✖ |
Cleared by FDA in use of newborns |
✔ |
✔ |
✔ |
Clinical Difference in Sensors |
|||
---|---|---|---|
Nellcor™ Pulse Oximetry Sensor* |
Stryker Reprocessed Sensor12 |
ConMed Dolphin Sensor13 |
|
Accuracy |
±3% in 60-80% SpO2 |
No Low Sat Accuracy in 60%-80%, ±3% in 70%-100% in adults, ±4% in 70-100% in neonates. |
No Low Sat Accuracy |
Motion |
Yes, ISO Approved |
No, not validated when reprocessed, no longer original manufacturer specifications |
No, not validated |
Clinical Testing |
Validated with human subjects |
Unable to identify documentation |
No validation on human subjects, only mechanical |
CCHD Requirements |
Meets all CCHD screening recommendations |
Does not meet all CCHD requirements, see above |
Does not meet all CCHD requirements, see above |
*Range Applicability: Ranges apply to Nellcor™ pulse oximetry OXIMAX, MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P sensors; see sensor IFUs for complete information.
Car seats used to transport infants put them in a semi-reclined position that could be risky for preterm and low birth weight infants. The car seat challenge helps identify potential cardiac and respiratory problems. As a precaution, these infants should be monitored in the car seat that will be used to transport them after discharge.14
The car seat challenge gives a final assessment before discharging a newborn who may carry a heightened risk of respiratory compromise.
The data a pulse oximeter generates could lead physicians to intervene with supplemental oxygen that can address frequent desaturation, apnea, or other problems.15 Because excess oxygen poses risks, particular to preterm and low birthweight infants, the pulse oximeter used for monitoring must demonstrate a high level of accuracy.6
Accuracy is also important because the ideal target range for oxygen saturation for extremely low birth weight infants can vary from patient to patient.15 All infants younger than 37 weeks gestation and term infants with various birth defects are at risk for desaturation.14 However, factors including gestational age, chronologic age, underlying disease, and transfusion status will influence whether car seat challenge events are significant.16
Read More† Oxygen saturation accuracy can be affected by certain environmental, equipment, and patient physiologic conditions (as discussed in the operator’s manual for the monitor) that influence readings of SpO2. Please consult the IFU and manual for full safety information.
When providing neonatal care you need to follow proven guidelines. Having this information at your fingertips can help keep the specifics of these best practices top of mind. That’s why we are offering a neonatal guidelines resource kit. This education kit contains a badge insert, monitor hang tags, posters, and more to give you easy access to important neonatal care information. Please fill out the form below to receive your kit in the mail.
The size, stability, and values of the company behind the products make a crucial difference to you and your patients. Our mission guides everything we do, including the meticulous standards-based research, development, and testing for which we’re known.
The Nellcor™ pulse oximetry monitoring system should not be used as the sole basis for diagnosis or therapy and is intended only as an adjunct in patient assessment.
1. Wyckoff MH, Aziz K, Escobedo MB, et al. Part 13: neonatal resuscitation: 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2015;132(suppl 2):S543–S560.
2. Saraswat A, Simionato LK, Dawson JA, Thio M, Kamlin O, Owen L, et al. Determining the best method for Nellcor pulse oximeter sensor application. Acta Paediatr. 2011;10:1-4.
3. O’Donnell CP, Kamlin CO, Davis PG, Morley CJ. Obtaining pulse oximetry data in neonates: a randomized crossover study of sensor application techniques. Arch Dis Child Fetal Neonatal Ed. 2005;90(1);F84-F85.
4. American Heart Association and American Academy of Pediatrics. Summary AAP/AHA 2015 Guidelines for cardiopulmonary resuscitation and emergency cardiovascular care of the neonate.
5. Akinloye O, O'Connell C, Allen AC, El-Naggar W. Post-resuscitation care for neonates receiving positive pressure ventilation at birth. Pediatrics. 2014;134(4):e1057–e1062.
6. Sundaram V, Louis D, Saini SS, Kumar P. Pulse oximetry sensor application for neonates during resuscitation (protocol). Cochrane Database of Systematic Reviews. 2016. doi.org/10.1002/14651858.CD012297
7. Rabi Y, Dawson JA. Oxygen therapy and oximetry in the delivery room. Semin Fetal Neonatal Med. 2013;18(6):330-5. doi: 10.1016/j.siny.2013.08.007.
8. Khoury R, Klinger G, Shir Y, Osovsky M, Bromiker R. Monitoring oxygen saturation and heart rate during neonatal transition. comparison between two different pulse oximeters and electrocardiography. J Perinatol. 2020 Nov 30. doi: 10.1038/s41372-020-00881-y. Epub ahead of print. PMID: 33250516.
9. Mahle WT, Martin GR, Beekman RH, et al. Endorsement of Health and Human Services recommendation for pulse oximetry screening for critical congenital heart disease. Pediatrics. 2012;129;190.
10. Van Niekerk AM, Cullis RM, Linley LL, Zühlke L . Feasibility of pulse oximetry pre-discharge screening implementation for detecting critical congenital heart lesions in newborns in a secondary level maternity hospital in the Western Cape, South Africa: The 'POPSICLe' study. S Afr Med J. 2016;106(8):817-821.
11. Kemper AR, Mahle WT, Martin GR, et al. Strategies for implementing screening for critical congenital heart disease. Pediatrics. 2011;128(5):e1259–e1267.
12. -NELL1: 10011350 (N600x) - Clinical Summary Report for N600x including the following validation studies: 1) N600x performance with MaxA, MaxFast, SC-A, DS-100A, OxiCliq A, D-YSE at 70-100% saturation range and 2) N600x comparision to N595/MaxA.
-10028895 - MP100_O6 (Nell 1 equivalent) - Clinical Summary Report including validation of accuracy of MP100-O6 with Max AL, DS100A, D-YSE, OxiCliq, SC-A and MaxFast.
13. Reprocessed Pulse Oximeter Sensor [instructions for use]. Tempe, AZ: Stryker; 2006, 2011.
14. Dolphin 2000™* Pulse Oximetry Sensor [510(K) Summary of Safety and Effectiveness]. Hawthorne, CA; Dolphin Medical Inc.; 2002.
15. Bull MJ, Engle WA. Safe transportation of preterm and low birth weight infants at hospital discharge. Pediatrics. 2009;123(5):1424-1429.
16. Cummings JJ, Richard Polin RA, Committee on Fetus and Newborn. Oxygen Targeting in Extremely Low Birth Weight Infants. Pediatrics. 2016;138(2): e20161576.
17. -MB05N (MFR):RE10096395-Report, Clinical, Motion, Connery OEM Module including the clinical evaluations of Connery 3.1 board with N-600x and MaxA and MaxFast sensors.
-PMB10N (LP100):10143241 - Clinical Report, Springboard OxiCable Motion Study including validation of motion performance during controlled hypoxia with MaxA and Max N over 70-100% saturation.