My friend Nick Hall asked a very important question on Linkedin today in the following post
Nick is a tremendous advocate for premature infants and their families everywhere and as President and Co-Founder of Graham’s Foundation certainly puts himself front and centre. For more information on the incredible work he and his team are doing please see their website at and if you are in the New York area please consider attending their charity benefit to help raise some funds to continue the work that they do.
As it pertains to his question though it did get me thinking. How does a National body like the AAP determine best practice suggestions for a country with 50 states in which roughly 320 million people reside? Using 2013 USA census data ,showing 23.1% of it’s citizens are under 18 this equates to nearly 74 million children. This is a daunting task no doubt and due to regional variation in terms of expertise and available resources not all policies or guidelines are possible to implement equally or at all.
The article that is being addressed in his question of the day is from Med City News which addresses the latest statement from the AAP on managing an anticipated birth before 25 weeks. For the actual statement that the article refers to please see this link which will direct you to the actual paper.
When the Canadian Pediatric Society (CPS) reaffirmed their statement in January 2015 it drew a fair bit of criticism from Canadian Neonatologists and others from abroad due to it’s draconian approach to infants at 22 and 23 weeks gestation. In the CPS statement the following was written in the recommendations section with respect to these two gestational ages which also encompassed 24 weeks as well.
“At 22 weeks’ GA since survival is uncommon, a non-interventional approach is recommended with focus on comfort care”
“At 23 and 24 weeks’ GA active treatment is appropriate for some infants”
What drew the ire of these health care providers was the apparent limitation of resuscitation based on gestational age. It did not seem that consideration was being given to potential inaccuracies with gestational age dating which at best in the first trimester are +/- a few days and in the second trimester may be off up to 1-2 weeks. Furthermore no mention was made of accounting for other factors such as the findings on an ultrasound which if very discrepant might suggest an older fetus or perhaps equally important the wishes of the parents. What were their past experiences, religious beliefs or lengths to which they had tried for this pregnancy. The 16 year old single mother who conceived via rape might be expected to have a vastly different perspective than the mother at 43 who has tried 5 rounds of IVF and has finally conceived her first baby. Many of these points were highlighted in a response by a large group of care providers in a paper entitled “CPS position statement for prenatal counselling before a premature birth: Simple rules for complicated decisions.”
Now we have a new statement from the American Academy of Pediatrics which I have to complement as it addresses a number of concerns that the above group had with the Canadian version.
1. Fetal gestational age, as currently estimated, is an imprecise predictor of neonatal survival, but 22 weeks of gestation is generally accepted as the lower threshold of viability.
2. Although most infants delivered between 22 and 24 weeks’ gestation will die in the neonatal period or have significant long-term neurodevelopmental morbidity, outcomes in individual cases are difficult to predict.
3. Outcomes of infants delivered at 22 to 24 weeks of gestation vary significantly from center to center.
4. Because of the uncertain outcomes for infants born at 22 to 24 weeks’ gestation, it is reasonable that decision-making regarding the delivery room management be individualized and family centered, taking into account known fetal and maternal conditions and risk factors as well as parental beliefs regarding the best interest of the child.
The first four points address the issues of uncertainty in dates, variable outcomes and the importance of taking a family centred approach. On the surface this seems like the perfect statement but I have highlighted the third point as it really gets to what Nick Hall is referring to (or at least my interpretation). We know that there is a great variability in outcomes from 22-26 weeks across the US based on the recent study by Rysavy et al. In this study which involved 24 hospitals with tertiary care centres, the median survival across all hospitals at 22 weeks (who actively resuscitated infants) ranged from 0 – 14.6% and at 23 weeks 23.8 – 37.1%. Imagine you are a parent at a centre that has a zero percent survival rate at 22 weeks. Should the hospital inform you of that and if after hearing that you still want “everything done” should the Neonatal team resuscitate your infant? There is no doubt that the parental wishes as outlined in point 4 are important but I would counter that there is also little point in putting a family through a futile exercise.
Vince Lombardi the former head coach of the Green Bay Packers produced the following quote that has been used many times since his heyday in the 1960s. “Practice does not make perfect. Only perfect practice makes perfect”
This could not be more applicable to the situation in many centres thoughout the US. Resuscitating 22 and 23 week infants can be done and in a manner of speaking is a form of practice. Should centres though who have not “perfected” their approach by having rigorous audits of their practice, a “golden hour” approach and lastly the best equipment for resuscitation continue to offer families who wish to “do everything” just that? I would say no. While the AAP certainly endorses this type of approach centres need to be honest and disclose their success with such resuscitations. If you have zero survivors and know that there is a non standard approach at delivery of such patients and substandard equipment such as the absence of blenders to allow less than 100% O2 resuscitation do you not have a moral and ethical obligation to draw the line and say no?
The AAP offers the best approach to resuscitation from 22-25 weeks that I have seen but I don’t believe it is for every centre at the moment. Only those centres who believe that they have all the infrastructure and processes in place to achieve “perfect practice” should be routinely resuscitating infants at 22 and 23 weeks. To continue to offer these families everything and perform less than perfect practice will not lead to any improvements in their rate of success and do the families that come to their hospitals a disservice.
The first step in medicine is to pledge to do no harm. I would hope that hospitals would be honest with themselves and if they don’t have everything in place to achieve great results will spare families the experience of false hope when the only outcome will be the inevitable loss of a child.
I was asked to see a woman carrying a fetus this week who was not yet 21 weeks. It was to be honest a very unusual consult as she was clearly pre-viable to me and this was only the second time in my career that I had been asked to do so before 22 or 23 weeks. In the course of our conversation she said the following:
“I know I just have to get to 22 weeks. Everyone knows that at St. Boniface Hospital they are saving kids at 22 weeks now and they will try to resuscitate mine if I can just get a little longer out of this pregnancy”
You might think I was shocked to hear this but I wasn’t as I had warned a group of health professionals ironically minutes earlier that we were going to start hearing things like this due to misinterpretations of both the medical literature and mainstream media. When I asked her where she heard this, her response was that everyone at the clinic she goes to are talking about it. I can only wonder how many other clinics, mom’s groups, Twitter and Facebook posts are saying the same thing! I spent some time with her and provided her with my view on the topic and we agreed not to do anything for her infant until they were bigger (currently was under 300g) and at least 22 5/7 weeks. I am not saying I necessarily believe we should strongly go for an infant at 22 5/7 weeks but she is right that we have and if taking in all the information she wants us to try, now that the public is aware how can we not?
Before I go on let me be clear about the actual state in our city at the moment:
WE ARE NOT RECOMMENDING RESUSCITATION OF ALL INFANTS AT 22 WEEKS OR EVEN 23 WEEKS BUT ARE HAVING DISCUSSIONS ABOUT 23 WEEKS
One Article Causes A Great Stir
In late April the New England Journal of Medicine published an article entitled Between-Hospital Variation in Treatment and Outcomes in Extremely Preterm Infants. What followed were numerous media articles about infants born at 22 or 23 weeks discussing the pros and cons of such actions. Furthermore an explosion of testimonies from parents who had infants resuscitated with good outcomes at these gestational ages ensued. Given that this topic was a hot one and in the public eye, our own local health news agency got in on the action and published the following story called Meet Mac: one of the youngest babies born at St. Boniface Hospital which was reprinted by the Free Press thereby achieving a larger audience.
The family is wonderful, the child simply amazing and much like many of the aforementioned similar stories on Facebook and Twitter inspires people to have hope. We all want in the end to feel good about things rather than dwell in sorrow so when these stories come along we tend to see them in a favourable light rather than critically analyze what they mean in the context of the greater picture. In the article they reference, such children as miracle babies and in many respects this is true. Before I go on I feel the need to point out that I am delighted for Mac’s family and admire their perseverance through many dark days. There is no question that they are a loving family who will love him for the rest of his life and provide a wonderful nurturing environment. The concern I have is that they are in the 5% or less of families that have this experience.
If we look at the article referenced above from the United States which is the largest study to date looking at extremely low birth weight infants the findings were that 95% of those infants who people tried to resuscitate at 22 weeks either died or were left with moderate to severe disabilities. This means 5% survive with only mild or no disability. It is the 5% we tend to hear about in the media and are the ones that create the buzz.
Looking For National Guidance
The fly in the ointment in all of this is that the Canadian Pediatric Society that provides recommendations in such situations is also under fire for its statement on Counselling and Management of Extremely Preterm Birth. In this statement in the recommendations section they state: At 22 weeks’ GA, since survival is uncommon, a non-interventional approach is recommended with focus on comfort care. (Strong Recommendation). In response to this statement a great number of practitioners banded together to write a rebuttal that was published in Pediatrics and Child Health in which they believe that the CPS has created simple rules for complicated decisions as the title of the article suggests. The gist of the article is that gestational age alone is inaccurate and using other prognostic factors in addition to gestational age is a better way of guiding decisions. Factors such as estimated weight and certainty of dates for example should come into the picture. Time will tell how the CPS responds but certainly organizations such as the Canadian Premature Babies Foundation are siding with the authors of the response to the CPS.
Make no mistake, this is a complicated issue and it will not go away anytime soon. While we are not advocating for 22 week infants to be resuscitated routinely, the fact remains if well informed parents decide they want to try it will be difficult to say no. Parents need to understand however that for infants to have the best chance, a coordinated approach with Obstetrics and Neonatology is critical to ensure the best chances. Furthermore seeking the opinion of a Bioethicist would help crystallize some of the issues that I know many are struggling with. Failure to receive antenatal steroids at 22 or 23 weeks for example is clearly shown in this article to reduce the likelihood of a positive outcome. Having a face to face discussion between the Neonatologist and Obstetrician and presenting a unified message to the family will be an imperative first step in any discussion. Furthermore having clear direction in a resuscitation and best practices worked out in the NICU to ensure that skin integrity is maintained is a must. We have a long road ahead of us before we can truly say that we are offering the best chances to these tiny infants but with collaborative efforts between our members in Neonatology and Obstetrics I believe we can get there.
In the meantime we each need to do our part and use our voices (or writing such as this) send a clear message to the public that while we celebrate with the families who have had such great outcomes at these gestational ages we all too often are mourning the loss of the vast majority who were not so fortunate.
Virtually every popular media site and especially those dedicated to covering the world of Obstetrics and Neonatology have been ablaze with discussions on the NEJM paper Between-Hospital Variation in Treatment and Outcomes in Extremely Preterm Infants. Since this publication, numerous blogging sites have similarly expanded on the coverage with testimonials of success stories of infants born too small or too young who survived and in most cases nearly intact.
Other posts are even more sensational, claiming that the infants have done extremely well and are in fact normal and healthy. The stories capture all of our attention and as feel good pieces give us pause to reflect on the tenacity of our beliefs either for or against resuscitation of these patients. Even more powerful are those instances when our health care teams experience a good outcome at these gestational ages. These types of cases challenge even the most ardent individuals that as a rule we should not intervene before 24 weeks.
How Likely Is A Good Outcome at 22 & 23 weeks?
What we have to remember though is that at least for the 22 week infants < 10% of those reported in the US cohort survived without moderate or severe disability and in the case of the 23 week infants these numbers although better, gave a 1/6 chance of surviving without that outcome. Flipping this number on its head to present a glass is half empty argument, there is a 5/6 or an 83% chance that a child born at 23 weeks who is actively resuscitated will either die or be left with a moderate or severe disability. The blog posts from this group of parents are far less common, although I have no doubt many of these parents were happy they at least tried. Had they not they would have been left wondering for the rest of their lives “what if”?
The purpose of this post is not to debate the rightness or wrongness of the desire to resuscitate or not. Rather I would like to discuss the fallacy of thinking that informed consent plays any role in most of these cases. All too often clinicians hide behind the veil of “informed consent” as justification for the family choosing to move forward with the decision to try to resuscitate these small infants. Is that what is really happening though in most cases? Sadly, in the nearly 12 years I have been in practice in these circumstances I suspect the conditions for true informed consent have been absent more often than not. Yet the Canadian Pediatric Society lists as the third recommendation in the statement “Counselling and management for anticipated extremely preterm birth”
“Decision making between parents and health professionals should be an informed and shared process. Decision aids may be helpful for parents. (Strong Recommendation)”
The issue lies in the criteria to obtain informed consent.
The Merriam-Webster Dictionary provides this definition:
“A formal agreement that a patient signs to give permission for a medical procedure (such as surgery) after having been told about the risks, benefits, etc.”
Unless a family has previous experience with a baby born at 23 or 24 weeks (outcomes after that become quite different), or they themselves work in the field of Pediatrics and have seen the range of outcomes that these children experience, how can they really know what the risks and benefits are?
As a young medical student I recall being told time and time again to be careful about the use of medical jargon. Rather, ensure that you use lay terminology that the parents can understand, in order to ensure that informed consent can be obtained or that the family understands the clinical course of their child. How many times have I talked to families using such words of wisdom only to think in the back of my mind; “do they really understand what I am saying?”.
What do they know of chronic lung disease, PDA, IVH, ROP and a host of other problems? What can they possibly know what their lives will be like in 2, 5 or 10 years down the road should their infant survive but with a host of major medical issues? Add to this, that in many cases there is little time for discussion as the mother presents with rupture of the membranes and goes on to deliver within 48 hours of presentation and often an even shorter time frame. Furthermore, the history of the pregnancy can be extremely motivational in helping a family decide what course is right for them. How does the mother who has had three rounds of IVF perceive the situation compared to the 16 year old who had an unplanned pregnancy. Clearly the psychological factors at play must have a tremendous influence on the decision.
Many parents are simply not in a state to receive the information even if it is presented well.
A study by Boss R et al suggests that what we say has very little impact on the parental decisions (Values parents apply to decision-making regarding delivery room resuscitation for high-risk newborns). In this paper, 26 mothers responded to a questionnaire at a minimum of 10 months after the death of their infant who was born between 22 and 25 weeks. After being asked about the discussions they had with their Neonatologist and Obstetricians these were the four main points uncovered.
1. Parents rarely perceive that there are options for delivery room resuscitation. They recall being told information but rarely that compassionate care was even an option even if this was documented in the chart.
2. Physicians’s predictions of morbidity and death are not central to parental decision-making regarding delivery room resuscitation. In essence the parent’s “gut instinct” which was nearly uniformly positive guided their decision.
3. Religion spirituality and hope are the primary values that parents apply to decision-making regarding delivery room resuscitation.
4. Parents feel abandoned without physician hope and compassion. There was mistrust of doctors who only emphasized the negative without a sense of emotion. Relaying the facts is not enough.
When under such stress is it possible for families to weigh all of the true risks and benefits and come to a conclusion that satisfies the requirements for informed consent? Given that to do so requires that an individual be in a state that allows them to process this information and take their time in coming to a conclusion I think in most cases the answer is no.
Planning a Path Forward
If your centre is planning to cross over the threshold of 24 weeks there must be a coordinated plan between the delivering obstetrician, neonatal team and family. Most parents are in no position to truly appreciate what we are telling them either because of the emotional frightened state they are in or because the overpowering urge to “do everything you can” takes a front and centre position in their mind. All we can do as the Health Care providers is to provide them with as accurate information as we can and support each family after they make their decision. Once that decision is made we must also realize that once we embark on a path it is not permanent. If the condition of the newborn is such that survival without severe disability becomes increasingly unlikely we owe it to the whole team (including the family at the centre) to revisit what would be the best course of action.