Archives | All Things Neonatal

Nitric oxide & Congenital Diaphragmatic Hernia; not so safe after all?

by All Things Neonatal | Oct 27, 2016 | CDH, nitric oxide, Uncategorized

As a young resident I have a vivid memory of a baby with CDH having saturations of 60 – 65% despite HFOV, paralysis and alkalinization (yes we used to do that). It was at that time that I pretty much threw my hands in the air and declared there was really nothing left that we could do. One of my mentors, a very wise Neonatologist Dr. Henrique Rigatto looked at me and said “why don’t we try inhaled nitric oxide?” Being the resident immersed in the burgeoning field of evidence based medicine I questioned him on this stating “But the evidence shows no benefit of iNO in CDH in any trials”. He looked back at me and asked “Are you prepared to let this baby die without even trying it?”. When put that way I answered shyly that I would order the iNO and… it worked. Whether it was coincidence or not I cannot say but I felt he had a point which I have shared many times with students over the years. A drug may not show a benefit in a clinical RCT so at a population level it should not be our ” go to” drug of choice but on an individual level as a last resort sometimes these medications for an individual patient may make a difference. Looking at it from a different standpoint one might say it falls into the “can’t hurt but might help” category of therapy.

Or is it safe in CDH?

The Congenital Diaphragmatic Hernia Study Group (CDHSG) of which we are a contributing centre recently published a retrospective analysis of the registry (now including over 9000 patients!) in an attempt to answer whether iNO use in babies with CDH is indeed safe. Evaluation of Variability in Inhaled Nitric Oxide Use and Pulmonary Hypertension in Patients With Congenital Diaphragmatic Hernia.

The study looked at 2047 patients treated with iNO most of whom received 20 ppm of iNO. Interestingly about 15% of the patients treated with iNO did not have pulonary hypertension on ECHO. The study found a positive association between centres using iNO and mortality. Moreover as the number of centres increased over time that used iNO so did the overall mortality in the study cohort. Beyond just looking at the trend in mortality with increasing use the authors took this one step further and used the statistical technique of propensity scoring to determine the attributable risk to mortality of using iNO in patients with CDH.

Propensity scoring is an interesting technique that one can use to estimate risk when it is unlikely that a randomized controlled trial will be available and this is one of those cases. The technique uses an approach which strives to balance the variables that determined why different patients received a treatment so when comparing the outcomes of the two groups you manage to isolate the effect to just the treatment that is being studied. In this case the technique indicates that the estimate of harm is estimated to be 15% meaning that there is an estimated 15% increase in mortality for patients with CDH treated with iNO regardless of the indication.

So what to do with our next patient?

I can’t help but think back to the words of one of my mentors and ask myself what I would do if I was confronted with a patient who had CDH and was saturating poorly. I think what this study adds perhaps is that one should tread carefully with iNO in the setting of CDH. Maybe the overall message is that one should not jump to use iNO early in treatment. Optimizing ventilation, use of analgesics and sedation and even paralysis may be a better approach to controlling oxygenation than early iNO. When all those have been tried though and the patient is still not responding I think those wise words from long ago carry a lot of weight. “Are you prepared to let this baby die without even trying it?”

When mortality is already a strong possibility I believe at least for me the answer will remain no. I think it is important to keep iNO in your back pocket but to let a patient die without trying would leave me forever asking “what if”. That is a question I am certainly not comfortable asking at all.

Free parking to increase parental visitation

by All Things Neonatal | Oct 19, 2016 | preemie, Uncategorized

This is a title that I hope caught your eye. In the nearly twenty years I have been in the field of Pediatrics the topic of parking being a barrier to parental visitation has come up again and again. A few years ago the concern about the cost of parking was so great that I was asked if I could find a pool of donors to purchase parking passes to offset the burden to the family. The theory of course is based on the idea that if parking were free in the NICU parents would visit more. If parents visit more they will be more involved in the care of their baby, more likely to breastfeed and with both of these situations in play the infant should be discharged earlier than other infants whose parents don’t visit. Try as I might it was a tough sell for donors who tend to prefer buying something more tangible that may bear their name or at least something they can look at and say “I bought that”. This is quite tough when it comes to a parking stall and as such I am still looking for that elusive donor. Having said that, is there any basis to believe that free parking is the solution that will deliver us from minimal visitation by some parents?

A Study May Help Answer The Question

Northrup TF et al published an article that was sent my way and to be honest I couldn’t wait to read it. A free parking trial to increase visitation and improve extremely low birth weight infant outcomes. This is like the holy grail of studies. A study that gets right to the point and attempts to answer the exact question I and others have been asking for some time. The study took place in Houston, Texas and was set up as an RCT in which families were randomized into two groups. Inclusion criteria were birth weight ⩽1000 g, age 7 to 14 days and deemed likely to survive. Seventy two patients were enrolled in the free parking group while 66 were placed in the usual care. Interestingly the power calculation determined that they would need 140 to show a difference so while 138 is close it wasn’t enough to truly show a difference but let’s see what they found.

The Results

Free parking made absolutely no difference for the whole group. Specifically there was no difference in the primary outcome of length of stay or hours spent per visit. Some interesting information though that may not be that surprising was found to be of importance in the table below.

It may not seem like a surprise but the patients who were more affluent and those who had less children tended to visit more. The latter makes a lot of sense as what are many people to do when they have one or more other children to care for at home especially in the face of little support? Would free parking make one iota of difference if the barrier has nothing to do with the out of pocket cost?

The conclusion was that the strategy didn’t work that well but as you may have picked up I think the study was flawed. By applying the strategy to all they were perhaps affected by choosing the wrong inclusion criteria. Taken to an extreme, would a 50 million dollar Powerball winner care one bit about parking vouchers? It wouldn’t make any difference to whether they were going to come or not. Similarly a single mother with 5 other kids who lives below the poverty line and has little support is not going to come more frequently whether they have a voucher or not.

What if the study were redone?

I see a need to redo this study again but with different parameters. What if you randomized people with a car or access to one who lived below a certain income level and had a committed support person who could assure that team that they could care for any other children the family had when called upon? Or one could look at families with no other children and see if offering free parking led to more frequent visitation and then from there higher rates of Kangaroo Care and breastfeeding. I for one haven’t given up on the idea and while I was truly excited to be sent this article and sadly initially dismayed on first read, I am hopeful that this story has not seen it’s end.

It is intuitive to me that for some parents parking is a barrier to visiting. Finding the right population to prove this though is the key to providing the evidence to arm our teams with evidence to gain support from hospital administrations. Without it we truly face an uphill battle to get this type of support for families. Stay tuned…

Autopilot Non-Invasive Ventilation

by All Things Neonatal | Oct 13, 2016 | preemie, Prematurity

I had a chance recently to drive a Tesla Model S with autopilot. Taking the car out on a fairly deserted road near my home I flicked the lever twice to activate the autopilot feature and put my hands behind my head while the vehicle took me where I wanted to go. As I cruised down the road with the wheel automatically turning with the curves in the road and the car speeding up or slowing down based on traffic and speed limit notices I couldn’t help but think of how such technology could be applied to medicine. How far away could the self driving ventilator or CPAP device be from development?

I have written about automatic saturation adjustments in a previous post but this referred to those patients on mechanical ventilation. Automatic adjustments of FiO2. Ready for prime time? Why is this goal so important to attain? The reasoning lies in the current design trends in modern NICUs. We are in the middle of a large movement towards single patient room NICUs which have many benefits such as privacy which may lead to enhanced breastfeeding rates and increased parental visitation. The downside, having spoken to people in centres where such designs are already in place is the challenge nursing faces when given multiple assignments of babies on O2. If you have to go from room to room and a baby is known to be labile in their O2 saturations it is human nature to turn the O2 up a little more than you otherwise would to give yourself a “cushion” while you are out of the room. I really don’t fault people in this circumstance but it does pose the question as to whether in a few years we will see a rise in oxygen related tissue injury such as CLD or ROP from such practice. In the previous post I wrote about babies who are ventilated but these infants will often be one to one nursed so the tendency to overshoot the O2 requirements may be less than the baby on non- invasive ventilation.

A System For Controlling O2 Automatically For Infants on Non-Invasive Ventilation

This month in Archives Dr. Dargaville and colleagues in Australia provide two papers, the first demonstrating the validation of the mathematical algorithm that they developed to control O2 and the second a clinical report outlining how well the system actually performed on patients. The theoretical paper Development and preclinical testing of an adaptive algorithm for automated control of inspired oxygen in the preterm infant. is a challenge to comprehend although validates the approach in the end while the clinical paper at least for me was easier to digest Clinical evaluation of a novel adaptive algorithm for automated control of oxygen therapy in preterm infants on non-invasive respiratory support.

The study was really a proof of concept with 20 preterm infants (mean GA 27.5 weeks, 8 days of age on average) included who each underwent two hours of manual control by nursing to keep saturations between 90-94% and then 4 hours of automated control (sats 91 – 95%) then back to manual for two hours. The slightly shifted ranges were required due to the way in which midpoint saturations are calculated. The essential setup was a computer equipped with an algorithm to make adjustments in FiO2 using an output to a motor that would adjust the O2 blender and then feedback from an O2 saturation monitor back to the computer. The system was equipped with an override to allow nursing to adjust in the event of poor signal or lack of response to the automatic adjustment.

The results though demonstrate that the system works and moreover does a very good job! The average percentage of time that the saturations were in the target range were significantly better with automated control (81% automated, 56% manual). As well as depicted in the following figure the amount of time spent in both hypoxic and hyperoxic ranges was considerable with manual control but non-existent on either tail with automated control (defined as < 85% or > 98% where black bars are manual control and white automatic).

From the figure you can see that the amount of time the patients are in target range are much higher with automatic control but is this simply because in addition to automatic control, nurses are “grabbing the wheel” and augmenting the system here? Not at all.

“During manual control epochs, FiO2 adjustments of at least 1% were made 2.3 (1.3–3.4) times/hour by bedside staff. During automated control, the minimum alteration to FiO2 of 0.5% was being actuated by the servomotor frequently (9.9 alterations/min overall), and changes to measured FiO2 of at least 1% occurred at a frequency of 64 (49–98) /hour. When in automated control, a total of 18 manual adjustments were made in all 20 recordings (0.24 adjustments/hour), a reduction by 90% from the rate of manual adjustments observed during manual control (2.3/hour).”

From the above quote from the paper it is clear that automated control works to keep the saturation goal through roughly 7 X the number of adjustments than nursing makes per hour. It is hard to keep up with that pace when you have multiple assignments but that is what you need I suppose! The use of the auto setting here reduced the amount of nursing interventions to adjust FiO2 by 90% and yields tighter control of O2 saturations.

Dare to Dream

Self driving oxygen administration is coming and this proof of concept needs to be developed and soon into a commercial solution. The risk of O2 damage to developing tissues is too great not to bring this technology forward to the masses. As we prepare to move into a new institution I sincerely hope that this solution arrives in time but regardless I know our nurses and RRTs will do their best as they always do until such a device comes along. When it does imagine all of the time that could be devoted to other areas of care once you were able to move away from the non-invasive device!

Stop guessing when the NICU team is needed at a delivery

by All Things Neonatal | Oct 6, 2016 | Neonatal, resuscitation

The other day I met with some colleagues from Obstetrics and other members from Neonatology to look at a new way of configuring our delivery suites. The question on the table was which deliveries which were always the domain of the high risk labour floor could be safely done in a lower acuity area. From a delivery standpoint they would have all the tools they need but issues might arise from a resuscitation point of view if more advanced resuscitation was needed. Would you have enough space for a full team, would all the equipment you need be available and overall what is in the best interests of the baby and family?

We looked at a longstanding list of conditions both antenatal and intrapartum and one by one tried to decide whether all of these were high risk or if some were more moderate. Could one predict based on a condition how much resuscitation they might need? As we worked our way through the list there was much discussion but in the end we were left with expert opinion as there was really no data to go by. For example, when the topic of IUGR infants came up we pooled our collective experience and all agreed that most of the time these babies seem to go quite well. After a few shoulder shrugs we were left feeling good about our decision to allow them to deliver in the new area. Now several days later I have some concern that our thinking was a little too simple. You see, conditions such as IUGR may present as the only risk factor for an adverse outcome but what if they also present with meconium or the need for a instrument assisted delivery. We would presume the risk for advanced resuscitation (meaning intubation or chest compressions and/or medication need) would be increased but is there a better way of predicting the extent of this risk?

Indeed there might just be

An interesting approach to answer this question has been taken by an Argentinian group in their paper Risk factors for advanced resuscitation in term and near-term infants: a case–control study. They chose to use a prospective case control study matching one case to 4 control infants who did not require resuscitation. The inclusion criteria were fairly straightforward. All babies had to be 34 weeks gestational age or greater and free of congenital malformations. By performing the study in 16 centres they were able to amass 61953 deliveries and for each case they found (N=196) they found 784 deliveries that were matched by day of birth. The idea here was that by matching consecutive patients who did not require resuscitation you were standardizing the teams that were present at delivery.

The antepartum and intrapartum risk factors that were then examined to determine strengths of association with need for resuscitation were obtained from the list of risks as per the NRP recommendations.

A Tool For All of Us?

What came out of their study was a simple yet effective tool that can help to predict the likelihood of a baby needing resuscitation when all factors are taken into account. By resuscitation the authors defined this as intubation, chest compressions or medications. This is pretty advanced resuscitation! In essence this is a tool that could help us answer the questions above with far better estimation than a shoulder shrug and an “I think so” response. The table can be found by clicking on this link to download but the table looks like this.

By inserting checks into the applicable boxes you get a calculated expected need for resuscitation. Let’s look at the example that I outlined at the start of the discussion which was an IUGR infant. It turns out that IUGR itself increases the background risk for infants 34 weeks and above from 6% to 55% with that one factor alone. Add in the presence of fetal bradycardia that is so often seen with each contraction in these babies and the risk increases to 97%! Based on these numbers I would be hesitant to say that most of these kids should do well. The majority in fact would seem to need some help to transition into this world.

Some words of caution

The definition here of resuscitation was intubation, chest compressions or medications. I would like to presume that the practioners in these centres were using NRP so with respect to chest compressions and medication use I would think this should be comparable to a centre such as ours. What I don’t know for sure is how quickly these centres move to intubate. NRP has always been fairly clear that infants may be intubated at several time points during a resuscitation although recent changes to NRP have put more emphasis on the use of CPAP to establish FRC and avoid intubation. Having said that this study took place from 2011 – 2013 so earlier than the push for CPAP began. I have to wonder what the effect of having an earlier approach to intubating might have had on these results. I can only speculate but perhaps it is irrelevant to some degree as even if in many cases these babies did not need intubation now they still would have likely needed CPAP. The need for any respiratory support adds a respiratory therapist into the mix which in a crowded space with the additional equipment needed makes a small room even smaller. Therefore while I may question the threshold to intubate I suspect these results are fairly applicable in at least picking out the likelihood of needing a Neonatal team in attendance.

Moreover I think we might have a quick tool on our hands for our Obstetrical colleagues to triage which deliveries they should really have us at. A tool that estimates the risk may be better than a shoulder shrug even if it overestimates when the goal is to ensure safety.

A blog post on well…physician bloggers

by All Things Neonatal | Oct 1, 2016 | Neonatal, Uncategorized

This is a posting of an article in Pediatrics. Always wondered whether this little venture of mine would be studied. Not this blog in particular but the whole concept in general! The credit of course for this post is not mine but Dr. Moreno who wrote the piece but as the link wouldn’t work well on the Facebook page independently here you go.

Mastering the Media: Physician bloggers identify benefits, barriers to using social media

Megan A. Moreno, M.D., M.S.Ed., M.P.H., FAAP

A growing number of physicians use social media as a professional platform for health communication. This trend is not lost on medical students and residents, who are among the demographic described as “most connected” via social media.In 2014, a medical student asked me to serve as her mentor for a public health research project. The student, Lauren Campbell, was interested in studying how physician bloggers see themselves and their role as bloggers, as well as the benefits and risks of blogging as a doctor. Given the newness of physician blogging, the purpose of the study was to understand the perspectives and experiences of physicians who could be considered early adopters of using social media to distribute health information.

We recruited physicians to take part in the study through website searches for physician bloggers, and in-depth telephone interviews were conducted with those who agreed to participate. At the end of the interview, participants were asked if they could recommend other physician bloggers, a technique known as “snowball sampling.”

Seventeen physicians participated in the study, which recently was published in BMC Medical Informatics and Decision Making (http://bit.ly/2bFtno9). About one-third were female and 76% were pediatricians.

Transcripts were analyzed for common themes mentioned across interviews.

Participants identified multiple perceived benefits and barriers to social media use by physicians. Benefits included forwarding career endeavors, keeping up with medical literature and increasing public exposure for their practice. Barriers included time, administrative hurdles to get permission from their institution to blog and fear of saying the wrong thing.

In addition, four major themes were commonly discussed across interviews. First, participants often saw themselves as “rugged individualists” who set their own rules for social media health communications, like cowboys taming the Wild West.

Second, participants expressed uncertainty about boundaries and strategies for social media use. They identified many gray areas such as what to post, how to post and how to set boundaries.

Third, an interesting and unexpected finding was that most of the physician bloggers described using social media much like traditional media, as a one-way communication platform or “soapbox” rather than as an interactive forum.

Finally, participants had disparate views regarding the time involved in social media use; some felt they could fit blogging into their day, while others saw it as an impediment to patient care.

From this study, we concluded that much uncertainty remains regarding roles and responsibilities of physicians providing medical content within social media, and opportunities exist for providers to use social media platforms interactively and to their full potential.

It’s worth considering how the AAP Council on Communications and Media or the Academy could develop best practices to address some of this uncertainty and provide physicians with training or tools to use social media for its true interactive purpose. The hope is that future studies will investigate these key topics so the “Wild West” of physician blogging will become an integrated metropolis.

Dr. Moreno is a member of the AAP Council on Communications and Media Executive Committee.