I don’t envy our nurses who care for babies withdrawing from various opiates and other substances. These assignments are definitely a challenge and require a great deal of patience and depending on the shrillness of an infant’s cry a good set of earplugs. Nonetheless we do our best with these infants to keep them calm and avoid as much stimulation as we can as we attempt to minimize the excitability of their nervous system.
Over 40 years ago the Finnegan Neonatal Abstinence scoring system was developed to assist medical teams by providing as objective a system as possible to compare one infant to another and determine when and if a patient should be treated pharmacologically. Unfortunately there is a problem inherent with this scoring system. It is the same problem that exists when you don’t have a blinded research trial. Imagine you are caring for an infant and you were given no history about drug exposure. How might you score a patient like that compared to one in which you are told has been exposed to illicit substances? Your senses are heightened and moreover if you were told this baby is “withdrawing terribly” or “is awful at night” you are biased. How are you likely to score such a patient when they are “on the edge” of being counted as a 1 or a 0 in a category? I bet in many cases, especially if you haven’t taken care of many such patients you err on the side of caution and score them on the high side. It is human nature. When the possible outcome of failing to recognize a withdrawing patient is a seizure, no one wants to be on when it happens having their scoring questioned. Have a look at the scoring tool though.
There is a lot of stuff in there to check off! What if it could be simpler?
The ESC Tool
In early May, news began to break of an abstract being presented at the Pediatric Academic Society meeting. The news story from the AAP can be found here. The ESC tool is a three question tool used to assess whether an infant requires treatment for withdrawal.
E – Eat (is an infant is able to eat 1 or more ounce per feeding)
S – Sleeping (sleep for an hour or longer undisturbed)
C – Console (Be consoled in 10 minutes or less.)
If all three criteria are met, the patient does not need treatment. If one or more criteria are not met the housestaff are notified and first non-pharmacologic and then pharmacologic means are employed if necessary to control symptoms.
The authors did something quite interesting. They looked at 50 patients with 201 hospital days with prenatal exposures to opiates and applied the ESC criteria to guide treatment. Concurrently they captured the Finnegan scores but did not use them to guide treatment.
The findings I hope you will agree are quite interesting!
“FNASS scores indicated starting morphine in 30 infants (60%). Morphine was actually started on only 6 patients (12%) (p< 0.0001) based on the ESC approach. The FNASS led protocol directed initiating or increasing meds on 24.6% of days compared to 2.7% of days using the ESC approach (p< 0.0001). The FNASS approach directed that morphine was either not started or decreased on 65.8% of days compared with 94.4% of days using the ESC approach (p< 0.0001). There were no readmissions or reported adverse events.
Pretty amazing but…
The ESC approach greatly reduced the need for treatment and as the authors state there were no readmissions or reported adverse events. What we don’t know and will be needed I suspect before anyone will adopt this strategy (which I have to say again is so much simpler that current approaches) is how these children do in the long run. If the system is undertreating withdrawal, could we see downstream impacts of a “kinder and gentler” approach? One outcome that will be reported soon in the next month is length of stay. I am eagerly awaiting further results as I for one think that a simpler approach to these patients may be just what the doctor ordered. I think the nurses might thank us as well but we will see just how appropriate it is!
The Abstract reporting these findings can be found below
I have often said that if this came to pass as a mandatory requirement that I would make an announcement shortly thereafter that I was moving on to another career. I think people thought I was kidding but I can put in writing for all to see that I am serious! The subject has been discussed for some time as I can recall such talks with colleagues both in my current position and in other centres. The gist of the argument for staying in-house is that continuity is improved over that period and efficiency gained by avoiding handovers twice a day . How many times have you heard at signover that extubation will be considered for the following morning or to keep the status quo for another issue such as feeding until the next day. No doubt this is influenced by a new set of eyes being in the unit and a change in approach to being one of “putting out fires” overnight. The question then is whether having one Neonatologist there for 24 hours leads to better consistency and with it better outcomes. With respect to PICUs the AAP has previously recommended that 24 hour in-house coverage by an intensivist be the standard so should Neonatology follow suit?
A Tale of Two Periods
My friends in Calgary, Alberta underwent a change in practice in 2001 in which they transitioned from having an in-house model of Neonatologist coverage for 24 hours a day to one similar to our own centres where the Neonatologist after handover late afternoon could take call from home. An article hot off the presses entitled Twenty-Four hour in-house neonatologist coverage and long-term neurodevelopmental outcomes of preterm infants seeks to help answer this question. The team undertook a retrospective analysis of 387 infants born at < 28 weeks gestational age during the periods of 1998-2000 (24 hour period, N=179 infants) vs 2002 – 2004 (day coverage, N= 208 infants) with the goal of looking at the big picture being follow-up for developmental outcome at 3 years. This is an important outcome as one can look at lots of short term outcomes (which they also did) but in the end what matters most is whether the infants survive and if they do are they any different in the long term.
As with any such study it is important to look at whether the infants in the two periods are comparable in terms of risk factors for adverse outcome. Some differences do exist that are worth noting.
Increased risk factors in the 24 hour group
Smaller birthweight (875 vs 922 g)
Confirmed sepsis (23% vs 14%)
Postnatal steroids (45% vs 8%) – but duration of ventilation longer in the day coverage group likely due to less postnatal steroids ( 31 vs 21 days)
All of these factors would predict a worse outcome for these infants but in the end for the primary outcome of neurodevelopmental impairment there was no difference. Even after controlling for postnatal steroids, birth weight, sex and 5 minute apgar score there was still no difference.
What might this mean?
Looking at this with a glass is half full view one might say that with all of the factors above predicting worse outcome for infants, the fact that the groups are not different in outcome may mean that the 24 hour model does indeed confer a benefit. Maybe having a Neonatologist around the clock means that care is made that much better to offset the effect of these other risk factors? On the other hand another explanation could also be that the reason there is no difference is that the sample just isn’t big enough to show a difference. In other words the size of the study might be underpowered to find a difference in developmental outcome.
One of the conclusions in this study is that the presence of a Neonatologist around the clock may have led to earlier extubation and account for the nearly 10 day difference in duration of ventilation. While I would love to believe that for personal reasons I don’t think we can ignore the fact that in the earlier epoch almost 50% of the babies received postnatal steroids compared to 8% in the later period. Postnatal steroids work and they do so by helping us get babies off ventilators. It is hard to ignore that point although I woudl like to take credit for such an achievement.
For now it would appear that I don’t feel compelled to stay overnight in the hospital unless it is necessary due to patient condition necessitating me having my eye on the patient. I am not sure where our field will go in the future but for now I don’t see the evidence being there for a change in practice. With that I will retire to my bedroom while I am on call and get some rest (I hope).
As a Neonatologist I doubt there are many topics discussed over coffee more than BPD. It is our metric by which we tend to judge our performance as a team and centre possibly more than any other. This shouldn’t be that surprising. The dawn of Neonatology was exemplified by the development of ventilators capable of allowing those with RDS to have a chance at survival. As John F Kennedy discovered when his son Patrick was born at 34 weeks, without such technology available there just wasn’t much that one could do. As premature survival became more and more common and the gestational age at which this was possible younger and younger survivors began to emerge. These survivors had a condition with Northway described in 1967 as classical BPD. This fibrocystic disease which would cripple infants gave way with modern ventilation to the “new bpd”.
The disease has changed to one where many factors such as oxygen and chorioamnionitis combine to cause arrest of alveolar development along with abnormal branching and thickening of the pulmonary vasculature to create insufficient air/blood interfaces +/- pulmonary hypertension. This new form is prevalent in units across the world and generally appears as hazy lungs minus the cystic change for the most part seen previously. Defining when to diagnose BPD has been a challenge. Is it oxygen at 28 days, 36 weeks PMA, x-ray compatible change or something else? The 2000 NIH workshop on this topic created a new approach to defining BPD which underwent validation towards predicting downstream pulmonary morbidity in follow-up in 2005. That was over a decade ago and the question is whether this remains relevant today.
I don’t wish to make light of the need to track our rates of BPD but at times I have found myself asking “is this really important?” There are a number of reasons for saying this. A baby who comes off oxygen at 36 weeks and 1 day is classified as having BPD while the baby who comes off at 35 6/7 does not. Are they really that different? Is it BPD that is keeping our smallest babies in hospital these days? For the most part no. Even after they come off oxygen and other supports it is often the need to establish feeding or adequate weight prior to discharge that delays things these days. Given that many of our smallest infants also have apnea long past 36 weeks PMA we have all seen babies who are free of oxygen at 38 weeks who continue to have events that keep them in hospital. In short while we need to be careful to minimize lung injury and the consequences that may follow the same, does it matter if a baby comes off O2 at 36, 37 or 38 weeks if they aren’t being discharged due to apnea or feeding issues? It does matter for benchmarking purposes as one unit will use this marker to compare themselves against another in terms of performance. Is there something more though that we can hope to obtain?
When does BPD matter?
The real goal in preventing BPD or at least minimizing respiratory morbidity of any kind is to ensure that after discharge from the NICU we are sending out the healthiest babies we can into the community. Does a baby at 36 weeks and one day free of O2 and other support have a high risk of coming back to the hospital after discharge or might it be that those that are even older when they free of such treatments may be worse off after discharge. The longer it takes to come off support one would think, the more fragile you might be. This was the goal of an important study just published entitled Revisiting the Definition of Bronchopulmonary Dysplasia: Effect of Changing Panoply of Respiratory Support for Preterm Neonates. This work is yet another contribution to the pool of knowledge from the Canadian Neonatal Network. In short this was a retrospective cohort study of 1503 babies born at <29 weeks GA who were assessed at 18-21 months of age. The outcomes were serious respiratory morbidity defined as one of:
(1) 3 or more rehospitalizations after NICU discharge owing to respiratory problems (infectious or noninfectious);
(2) having a tracheostomy
(3) using respiratory monitoring or support devices at home such as an apnea monitor
or pulse oximeter
(4) being on home oxygen or continuous positive airway pressure at the time of assessment
While neurosensory impairment being one of:
(1) moderate to severe cerebral palsy (Gross Motor Function Classification System ≥3)
(2) severe developmental delay (Bayley Scales of Infant and Toddler
Development Third Edition [Bayley III] composite score <70 in either cognitive, language, or motor domains)
3) hearing aid or cochlear implant use
(4) bilateral severe visual impairment
What did they find?
The authors looked at 6 definitions of BPD and applied examined how predictive they were of these two outcomes. The combination of oxygen and/or respiratory support at 36 weeks PMA had the greatest capacity to predict this composite outcome. It was the secondary analysis though that peaked my interest. Once the authors identified the best predictor of adverse outcome they sought to examine the same combination of respiratory support and/oxygen at gestational ages from 34 -44 weeks PMA. The question here was whether the use of an arbitrary time point of 36 weeks is actually the best number to use when looking at these longer term outcomes. Great for benchmarking but is it great for predicting outcome?
It turns out the point in time with the greatest likelihood of predicting occurrence of serious respiratory morbidity is 40 weeks and not 36 weeks. Curiously, beyond 40 weeks it becomes less predictive. With respect to neurosensory impairment there is no real difference at any gestational age from 34-44 weeks PMA.
From the perspective of what we tell parents these results have some significance. If they are to be believed (and this is a very large sample) then the infant who remains on O2 at 37 weeks but is off by 38 or 39 weeks will likely fair better than the baby who remains on O2 or support at 40 weeks. It also means that the risk of neurosensory impairment is largely set in place if the infant born at < 29 weeks remains on O2 or support beyond 33 weeks. Should this surprise us? Maybe not. A baby who is on such support for over 5 weeks is sick and as a result the damage to the developing brain from O2 free radical damage and/or exposure to chorioamnionitis or sepsis is done.
It will be interesting to see how this study shapes the way we think about BPD. From a neurosensory standpoint striving to remove the need for support by 34 weeks may be a goal worth striving for. Failure to do so though may mean that we at least have some time to reduce the risk of serious respiratory morbidity after discharge.
Thank you to the CNN for putting out what I am sure will be a much discussed paper in the months to come.
The infant car seat challenge(ICSC) is a test which most definitely fits the definition of a battleground issue in Neonatology. After publishing the Canadian Pediatric Practice point on the same topic I received interesting feedback through the various social media forums that I frequent. While some were celebrating the consensus of the statement as verification that a centres’ non practice of the test was acceptable, others seriously questioned the validity of the position. The naysayers would point out that extremely infrequent events unless intentionally tracked may be difficult to pick up. In the case of the ICSC, if a few patients were to suffer a hypoxic event leading to an ALTE or worse after discharge, could the ICSC have picked out these babies and prevented the outcome? The evidence for adverse events associated with the use of car seats as discussed in the position statement is poor when using autopsy records over decades but when many clinicians can point to a failed ICSC picking up events, the thought goes that they “caught one”. Does catching one make a difference though?
The Well Appearing Infant
Shah et al in their recent paper Clinical Outcomes Associated with a Failed Infant Car Seat Challenge attempt to address this very point. They performed a retrospective study of 148 patients who were either <37 weeks GA or < 2500g at birth. The study was made possible by the fact that all such infants in their hospital admitted to a well newborn area meeting these criteria by policy must have an ICSC prior to discharge. Keep in mind that these were all infants who were on the well newborn service since they were asymptomatic. The definition of an event in this group was one or more of pulse oximeter saturation ≤ 85% for > 10 seconds, apnea > 20 seconds, bradycardia < 80 bpm for > 10 seconds, or an apnea or bradycardia event requiring stimulation. The failure rate was 4.5% which is very similar to other reported studies.
Why did they “fail”?
Failure of the ICSC was owing to desaturation 59%
Combination of 2 in 11%
What is interesting about these results is what happened to these infants after admission to the NICU in that 39% were identified with apnea (48% in preterm vs 17% in term infants). These events were in the supine position which is a curious finding since the ICSC was designed to find risk of cardiorespiratory stability in a semi-recumbent position. This has been shown previously though.
What does it all mean?
The infants in this study ultimately had more NG feeding, prolonged length of stay and septic workups after failing the ICSC that comparable infants who passed. At first blush one would read this article and immediately question the validity of the CPS position but then the real question is what has this added to the “pool of knowledge”. That infants may fail an ICSC at a rate of 4.5% is already known. That such infants may demonstrate apneic events has also been shown before and a study like this may help to support those clinicians who feel it is still imperative to find these infants in order to achieve a safe discharge. I think it is important to put these findings in the context of what would have happened if such a unit did not routinely test these types of babies. As all were seemingly well and I presume feeding with their families, they would have been discharged after 24-48 hours to home. We have no evidence (since they have not compared this sample to a group who did not have such testing) that if these babies were discharged they would have faired poorly.
The supporters of the ICSC would point to all the support these babies received by admitting them for 6-8 days, providing NG feeding and ruling out sepsis that they were unsafe for discharge. The other possible way to look at it was that the infants were subjected to interventions that we have no evidence helped them. Whether any of these infants had a positive blood culture justifying antibiotics or needed methylxanthine support is not mentioned. Judging however by the short length of stay I suspect that none or few of these infants needed such medication as I would expect they would have stayed much longer had they needed medical treatment for apnea.
I do commend the authors for completing the study and while it does raise some eyebrows, I don’t see it changing at least my position on the ICSC. While they have described a cohort of patients who failed the ICSC nicely, the fundamental question has been left unanswered. Does any of this matter? If you look well, are feeding well and free of any clinically recognizable events but are late preterm or IUGR can the ICSC prevent harm? This has not been answered here and perhaps the next step would be for a centre that has abandoned the ICSC to follow their patients after discharge prospectively and see whether any adverse outcomes do indeed occur. Any takers?
Throughout my career one thing has been consistently true. That is that wherever I was working and regardless of the role I have been an educator. I imagine the blog to a great extent is related to my interest in this aspect of my work. In the last few years much has been said about care by parents whether it be a general approach for family centred care or in formalized approaches such as FiCare which has also been formally studied in the research setting. When we speak of family centred care, one thing that I am constantly reminded of is that the focus of all of our efforts must be on the family and the patient. As I said recently to a colleague when discussing what was presented as a difficult discussion with another colleague due to a disagreement about the direction of management, when you put the patient first the discussion really isn’t difficult at all. It’s not about you or a colleagues ego but about the patient and if the management is not up to par then change direction and worry about managing egos later.
What We Know And What They Know
Another aspect that needs to be addressed is the difference in power that we have through knowledge. I am not talking about us exerting authority over families but from the perspective of us having the knowledge from years of experience in the field as to what is significant and what is not in terms of events in the NICU. The evidence for example with respect to neurodevelopmental outcome from apnea and bradycardia should give us reason to be optimistic the majority of the time. While in Edmonton I learned a great deal from one of my colleagues who was the lead author in a paper entitled Early childhood neurodevelopment in very low birth weight infants with predischarge apnea. While frequent apnea may be associated with mild motor impairments in their paper, the predictive value of these predischarge recordings is very limited when you take away those kids without severe IVH. I think about all of the parents we see who have their eyes glued to the monitors while they attend at the bedside and what they must be thinking. To us it is just a matter of time but I wonder for them how agonizing a time it really is! It isn’t just those infants who are nearing discharge and having apnea either as the CAP study at 5 years of age showed no difference in survival without disability in those infants who received caffeine vs those who did not. More frequent events may not be that detrimental after all. I am not suggesting we not treat patients as one never knows where the threshold lies to cause injury but these preemies are certainly made of some tough stuff.
Identifying Stress and Preparing Parents For it
The first step in dealing with this issue is to know it is there. Recognizing this, Melnyk and others performed an educational intervention targeting behaviour of families in their study Reducing premature infants’ length of stay and improving parents’ mental health outcomes with the Creating Opportunities for Parent Empowerment (COPE) neonatal intensive care unit program: a randomized, controlled trial. The group of parents who went through the program had better mental health outcomes compared to the control groups. The issue here and really is at the crux of the goal in writing all of this is that the stress that parents feel may not be overtly present. The squeaky wheel as the saying goes gets the grease and the parents that are demonstrating signs of poor coping are the first to draw the referrals to social work or engage in a deeper conversation with nursing at the bedside. All parents experience stress at least to a certain degree and it is all of our jobs to tease it out. On the other hand employing standardized approaches such as the COPE program for all parents might be another way of helping those who are in need but not clearly wearing a sign on their foreheads that say “help me”.
Don’t Underestimate the Power of Reassurance
So we know that much of what we see on the monitors will not lead to long term harm, transient central cyanosis during feeds will not damage the brain and apnea of prematurity is a distinct entity from SIDS. The parents on the other hand commonly make these links and additionally in case no one has mentioned it to you, those babies with TTN may one day develop asthma and those with hypoglycemia may have diabetes (we know both not to be true but I have been asked about this many times). This is why I believe it is our duty to explain why we are not worried about things that come up in the unit. Saying “don’t worry” or “that is normal preterm behaviour” may not be enough. Ask a parent what it is they are worried about and you may be surprised to find out the links that they have made in their heads, some of which may be valid but some completely false. I am not meaning to trivialize their concerns but rather validate them as real worries. If we have the knowledge and it is power as I said before then shouldn’t we use that power to help reduce their stress?
Engaging Families Can Reap Huge Dividends
The movement towards family centred care and more specifically care by parent will have a dramatic impact on this issue. As more and more centres move to engaging families to be part of rounds and not just listen and then ask questions but to take some degree of control and provide some of the reporting stress will be reduced. It is only logical. The more a family comes to understand what is significant and what is not in terms of reporting concerns the more confident they will be. Moreover, spending more time at the bedside leads to more skin to skin care and with that shorter hospital stays due to better cardiorespiratory stability. We aren’t there yet but we are headed in the right direction. In the meantime, take the time to ask a simple question “what are you worried about” to parents no matter how confident and strong they appear and you may find yourself with an opportunity to harness the power of education you have a make a real difference to a family in need.