It’s World Prematurity Day today and if you are a parent or are caring for a baby who has just entered this world before 37 weeks GA you are now part of a membership that counts 15 million new babies each year according to the WHO’s data. As I tell most new parents who have a baby admitted to our unit “It’s ok to take some time to adjust to this. You didn’t plan on being here”. That is true for most who go into spontaneous labour but of course those who are electively delivered due to maternal or fetal indications that have been followed closely often have time to prepare for the journey to the NICU. Many of these parents will have had the opportunity to visit the NICU or even connect with other parents before the anticipated birth of their child to at least get a glimpse into what life is like in the NICU. Much has been written about parental stress and methods to reduce it and I find that a piece that appeared in the Huffington Post offers some good pointers to helping parents manage the transition from pregnancy to NICU. The piece is entitled 5 Things Never To Say To Parents Of Preemies (And What To Say Instead). It is well worth a read but the one thing that stuck out in my mind is one very important thing to say.
Congratulations on the birth of your baby
There is no doubt that the family who gives birth to a preterm infant is experiencing stress. What may be lost in the first few days of surfactant, central lines and looking for sepsis among other things is that a new member of the 15 million strong has entered this world. They have a new child and just like anyone else should receive a congratulations. No one needs to tell them to be worried. They already are and likely view many of the possibilities more pessimistically than you do. Taking a moment to say congratulations though may go a long way to reminding them that amidst all this stress there is something to rejoice in and look to the future. If we aren’t supportive then I have no doubt the subconscious message is that they shouldn’t have hope either. I am not suggesting that we sugarcoat what is really going on but one can be honest about likely outcomes and still celebrate the arrival of a new baby. Much has also been written recently about a number of strategies to reduce stress in the NICU such as skin to skin care, integration of families more closely into the patient care team and forming parent support groups just to name a few. What else can be done to improve the quality of life for parents going through this journey?
Enrol Your Baby In A Research Study
I work in an academic centre and given the volume of research projects at any given time there is a need to approach families and sometimes quite soon after delivery. interestingly, I have heard from time to time that individuals have been hesitant to approach families due to a feeling that they are overwhelmed and won’t be receptive to being approached in this fragile state. I am guilty of the same thoughts from time to time but maybe it is time I reconsider. Nordheim T et al just published an interesting study on this topic entitled Quality of life in parents of preterm infants in a randomized nutritional intervention trial. This study was actually a study of parents within a study that called the PreNu trial that involved an intervention of a energy and protein supplemental strategy to enhance weight at discharge. The trial was an RCT and unfortunately although well intentioned was stopped when the intervention group was found to have an unexpected increase in sepsis rates. Although this study did not ultimately find a positive outcome there were additional analyses performed of quality of life and parental stress at two time points the first being during the hospital stay and the second at 3.5 years of age. The patients were all treated the same aside from the nutritional intake and in the end 30 intervention parents and 31 single parents not enrolled in a study (many in couples) participated in the study. In followup a little less than 70% completed the stress measures at 3.5 years. The results are found below.
How Do We Interpret This
The parents in this study who were part of the intervention group were about 3 years older so perhaps with more life experience may have developed some better coping strategies but during the hospital stay those who participated in research had better measures of quality of life and at three years better reports of sleep and energy levels. The study is quite small so we need to take all of this with a grain of salt with respect to the 3.5 year outcomes as there are so many variables that could happen along the way to explain this difference but I think it may be fair to acknowledge the quality of life measure during the stay. Why might parents report these findings? The finding of better quality of life is especially interesting given that more patients in this study had sepsis which one would think would make for a worse result. Here are a few thoughts.
- Involvement in research may have increased their knowledge base as they learned about nutrition and expected weight gain in the NICU.
- Frequent interaction with researchers may have given them more attention and with it more education.
- Some parents may have simply felt better about knowing they were helping others who would come after them. I have heard this comment myself many times and suspect that it would be attributable at least to a certain extent.
- A better understanding of the issues facing their infants through education may have reduced stress levels due to avoiding “fear of the unknown”.
Regardless of the exact reason behind the findings what stands out in my mind is that participation in research likely provides comfort for parents who are in the midst of tremendous stress. Is it the altruistic desire to help others or being able to find something good in the face of a guarded outlook? I don’t know but I do believe that what this study tells us is that we shouldn’t be afraid to approach families.
After first congratulating them give them a little time to absorb their new reality and then offer them the chance to improve the care for the next 15 million that will come this time next year for World Prematurity Day 2017.
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.
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…
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!
While we draw the line at 22 5/7 weeks for offering active resuscitation where I work, what does one do when the family requests resuscitation prior to that point. While I am a clear fan of social media, one consequence of having such widely available information at our fingertips is that families may already know before you come to speak with them that were they only to have been born in another place like Montreal, the cutoff would have been lower. When faced with such demands what does one do? Well, in the case of my own experience it was to give in to the demands of the parents. While I certainly discourage such heroic attempts, what is one to say when the family having received your opinion states “I want everything done”. Informed consent is a tricky one in that if you approach a family for informed consent and they refuse to accept your desired direction of care where does that leave you? It leaves you with informed refusal and if we are being fair to our families we have to accept that informed refusal is just as important as informed consent.
The truth is informed refusal has been recognized as being critically important to decisions in patient care for many years. Previous papers on the subject include a nice review by Ridley DT, Informed consent, informed refusal, informed choice–what is it that makes a patient’s medical treatment decisions informed? What this really comes down to is a patient’s right to personal autonomy and self determination. Does a parent in this case have the right to do what they want even in the face of dismal odds? Furthermore where are we placing the importance of values? Is it physician or patient centric? In the physician centric world, after we impart our experience and wisdom we expect the patient to generally follow through with what we are steering them towards in cases such as this. Informed consent of course is meant to be free of coercion but let’s face it, when we truly believe something is fairly futile are we honestly playing an impartial role or using our tone, body language and choice of words to direct families down the path that fits with our own beliefs and values? I would offer that in most cases when we seek informed consent what we are really doing is seeking to pass along the justification for what we are wanting to do and then moving forward once obtained.
What do we do though when after hearing the pros and cons the family still opts to move forward and worse yet is in disagreement with our preferred plan. Well there you arrive at informed refusal. If after hearing our best transfer of information the family still wants to proceed what does one do? As a physician if I believe something is completely futile and I find myself in this position then I am truly at fault. Seeking informed consent in this situation was completely inappropriate. One should have simply said there is nothing that can be done.
The Montreal Example
Getting back to the example that started this piece, if a family knows that there are places in Canada (or let’s be honest, if I know there are survivors in Canada at 22 weeks) that resuscitate and have survivors then it isn’t really futile is it. I know many of you would say “but the odds are so stacked against the baby” and “they don’t know what they are getting themselves into” but what does one say in this circumstance when despite your best attempts the family still wants to resuscitate?
Therein lies the challenge. If we approach this as an opportunity for informed consent we need to accept that we may find ourselves face to face with “informed refusal”. Now I need to be careful here. I am not advocating a wide open optimistic approach to resuscitation at 22 weeks. What I am suggesting though is that if you find yourself coming into a unit somewhere in the next few months and find yourselves looking at a 22 week infant don’t jump to conclusions! Did the family despite all the warnings want this? Don’t leap to the thought that the Neonatologist is pushing for this but rather it may indeed be a case of a family advocating for their child against all odds. It may not be something that we agree with in many cases but are we thinking from the perspective of the family or our own value system?
Preterm infants born between 22 to 25 weeks gestational age has been a topic covered in this blog before.
I think it is safe to say that this topic stirs up emotions on both sides of the argument of how aggressive to be when it comes to resuscitating some of these infants, particularly those at 22 and 23 weeks. Where I work we have drawn a line at 23 weeks for active resuscitation but there are those that would point out the challenge of creating such a hard-line when the accuracy of dating a pregnancy can be off by anywhere from 5 – 14 days. Having said that, this is what we have decided after much deliberation and before entertaining anything further it is critical to determine how well these infants are doing not just in terms of survival but also in the long run. In the next 6 months our first cohort should be coming up for their 18 month follow ups so this will be an informative time for sure.
Do Days Matter?
This is the subject of a short report out of Australia by Schindler T et al. In this communication they looked at the survival alone for preterm infants in a larger study but broke them down into 3 and four-day periods from 23 to 25 weeks as shown below.
The asterisk over the two bars means that the improvement in survival was statistically significant between being born in the last half of the preceding week and the first half of the next week. In this study in other words days make a difference. A word of caution is needed here though. When you look at the variation in survival in each category one sees that while the means are statistically different the error bars show some overlap with the previous half week. At a population level we are able to say that for the average late 23 week infant survival is expected to be about 30% in this study and about 55% at 24 +0-3 days. What do you say to the individual parent though? I am not suggesting that this information is useless as it serves to provide us with an average estimate of outcome. It also is important I believe in that it suggests that dating on average is fairly accurate. Yes the dates may be off for an individual by 5 – 14 days but overall when you group everyone together when a pregnancy is dated it is reasonably accurate for the population.
Don’t become a slave to the number
The goal of this post is to remind everyone that while these numbers are important for looking at average outcomes they do not provide strict guidance for outcome at the individual level. For an individual, the prenatal history including maternal nutrition, receipt of antenatal steroids, timing of pregnancy dating and weight of the fetus are just some of the factors that may lead us to be more or less optimistic about the chances for a fetus. Any decisions to either pursue or forego treatment should be based on conversations with families taking into account all factors that are pertinent to the decision for that family. Age is just a number as people say and I worry that a graph such as the one above that is certainly interesting may be used by some to sway families one way or another based on whether the clock has turned past 12 AM. At 23 weeks 3 days and 23 hours do we really think that the patient is that much better off than at 24 weeks 4 days and 1 hour?
It seems the expression “(insert a group) lives matter” is present everywhere these days so I thought I would join in after a moving experience I had today. For those of you who have been with the blog since the beginning you would have seen a number of posts that if you follow them in time, provide a glimpse into the transformation that Winnipeg has seen over the last year or so.
Prior to that point, 24 weeks was a cutoff for resuscitation that had been in place for some time and after a great amount of deliberation and thought was changed to 23 weeks. This did not come without a great deal of angst and a tremendous amount of education and teamwork that our nurse educators and clinical leads were so instrumental in helping to role out. The experience was outlined in a couple of posts that you may find interesting if you didn’t catch them the first time. The first was Winnipeg hospital now resuscitating all infants at 22 weeks! A media led case of broken telephone. and the second being Winnipeg Hospital About to Start Resuscitating Infants at 23 weeks!
Since these two posts we have certainly had our fair share of experience as we have seen far more babies than anticipated but the region has met the challenge head on and although the numbers are small we appear to have not only more survivors than expected but all but one infant had gone home without O2 and all have been demand feeding at discharge. While we await the 18 month outcomes, the results thus far appear reassuring.
A Special & Memorable Visit
Then today, a visit occurred from the first of such infants who is now just over a year of age. He was bright eyed, smiling, interactive and by his parent’s account, has normal tone and assessments thus far by physiotherapy. His presence in the NICU put smiles on faces and at least for myself made me think of the expression “Micropreemie Lives Matter”. He was a baby that everyone predicted would not survive and then when he did, that he would be grossly developmentally impaired which he does not appear to be in the least. His presence in the unit no doubt gives everyone who doubted the merits of moving down this path reason to pause.
Before you accuse me of wearing rose coloured glasses, make no mistake I know that he will not represent the outcome for everyone. In fact at one of our hospitals two of such infants have died while we await the 18 month outcomes for the other survivors. What his presence does though, is remind us or at least me that good outcomes are possible and in the case of our experience in Winnipeg may be more common that we thought they would be.
Black Swans and Human Nature
When I have spoken to audiences about the path forward when resuscitating such ELGANS I have often commented on the “Black Swan” effect. This was very nicely described by Nassim Taleb and described the human trait to react to unusual events with extreme reactions. An example is no one wanting to fly in the months after the world trade centre bombing when statistically this may have been the safest period in history to fly. Similarly, we as a team need to avoid the extreme reaction of saying that we should not be resuscitating such small infants when a bad outcome occurs. As I have told many people, we know these patients will not all survive, we know a significant number will have adverse development yet not all will and at least in our small sample thus far the babies would appear to be doing better overall than anticipated. If we know that bad outcomes will occur then why do we hear the questions come when they do such as “why are we doing this?”, “maybe we should rethink our position on 23 week infants”. It happens because we care and we hate seeing families and their babies go through such painful experiences. What we cannot do though for the sake of those such as our visitor today is react with a “Black Swan” reaction and steer the ship so to speak in the previous direction we were in. There are survivors and they may do well and that is why I say “Micropreemie Lives Matter”.
In the paper by Rysavy the overall finding at 23 weeks was that 1 out of 6 would survive without moderate or severe disability. What do we do as we increase our experience if the trend bears out that our outcomes are better? How will we counsel families? Will we continue to use the statistics from the paper or quote our own despite us being a medium sized centre?
The Big Questions
As our experience with such infants increases we will also no doubt see a change in our thoughts about infants at 24 weeks. I have seen this first hand already with a physician commenting today that 24 weeks is not such a big deal now! This brings me to the big question (which I will credit a nurse I work with for planting in my head in the last two weeks) which is for another time to answer as this post gets a little lengthy but is something to ponder. As our outcomes for 23 weeks improve and so do our results at 24 weeks (which is bound to happen with the more frequent team work in such situations) will our approach to infants at 24 weeks change. In our institution we generally follow the CPS guidelines for the management of infants at extremely low GA and offer the choice of resuscitation at 24 weeks. As outcomes improve at this GA will we continue to do so or will we reach a threshold where much like the case at 25 weeks we inform families that we will resuscitate their infant without providing the option of compassionate care?
It is too early to answer these questions conclusively but they are very deserving of some thought. Lastly, I would like to thank the parent who came by today for inspiring me and to all those who will follow afterwards.