Time To Give Antenatal Steroids After 34 weeks

Time To Give Antenatal Steroids After 34 weeks

In April of this year the ALPS trial results were published in the New England Journal of Medicine (Antenatal Betamethasone for Women at Risk for Late Preterm Delivery) and I took the time to review the paper at the time Antenatal Steroids After 34 weeks. Believe the hype?  In the analysis I focused on an issue which was relevant at the time, being a shortage of betamethasone.  In a situation when the drug of choice is in short supply I argued that while the benefits of giving steroid to women at risk of delivery between 34 0/7 to 36 6/7 weeks was there, if I had to choose (as I did at the time) I would save the doses for those at highest risk of adverse outcome.  Since the blog post though a couple of things have come out in the literature that I believe are worth sharing as it could truly influence practice.

Practice Advisory: Antenatal Corticosteroid Administration in the Late Preterm Period

The American College of Obstetricians and Gynecologists, moved by the results of the ALPS trial issued the following recommendations (shortened in places).

  • Betamethasone may be considered in women with a singleton pregnancy between 34 0/7 and 36 6/7 weeks gestation at imminent risk of preterm birth within 7 days.
  • Monitoring of late preterms for hypoglycemia (already being done)
  • Do not give in the setting of chorioamnionitis.
  • Tocolysis or delayed delivery for maternal indications should not be done in order to  to allow for administration of late preterm antenatal corticosteroids.
  • Do not provide if the pregnancy was already exposed to antenatal corticosteroids.

The exclusions above such as twins and triplets, diabetic pregnancies and previous receipt of steroids were included since the study had not included these patients.  As the ACOG states in the summary, they will be reviewing such indications in the future and providing recommendations.  I would imagine that if I were in a US based practice then this post might seem like old news since many centres would have started doing this.  Given that the readers of this blog are based in many different countries around the globe and at least in Canada this has not become commonplace I thought it would be worth the update!

Antenatal corticosteroids for maturity of term or near term fetuses: systematic review and meta-analysis of randomized controlled trials

I posted the abstract for this review on my Facebook page the other day and it certainly garnered a lot of interest.  Some of my readers indicated the practice is already underway. I was curious what a systematic review would reveal about the topic since the ACOG was so moved by the ALPS study in particular.  Perusing through the Society of Obstetricians and Gynecologists of Canada (SOGC) I can’t find any commentary on this topic and certainly there are no new clinical practice guidelines since the ALPS study landed on my desktop.

Here are the pooled results from 6 trials:

  1. Lower risk of RDS (relative risk 0.74, 95% confidence interval 0.61 to 0.91)
    1. Mild RDS (0.67, 0.46 to 0.96)
    2. Moderate RDS (0.39, 0.18 to 0.89)
    3. Severe RDS (0.55, 0.33 to 0.91)
  2. Transient tachypnea of the newborn (0.56, 0.37 to 0.86)
  3. Shorter stay on a neonatal intensive care unit (−7.64 days, −7.65 to −7.64)

So across the board patients who receive antenatal steroids after 34 weeks still continue to see a benefit but looked at a different way the real benefit of the intervention is easier to see and that is through looking at the number needed to treat (NNT).  For those of you who are not familiar with this analysis, this looks at how many patients one would need to treat in order to avoid the outcome in 1 patient.

For the outcomes above as an example the NNT for RDS overall is about 59 while for TTN 31 patients.  Severe RDS which is less common after 34 weeks you might expect to require more patients to treat to help 1 avoid the outcome and you would be correct.  That number is 118 patients.  It is interesting to look at the impact of steroids in pregnancies below 34 weeks (taken from the Cochrane review on the subject) as the NNT there is 23!  If you were to break these benefits down from 23-27 weeks though where the risk of RDS is quite high the NNT would be even lower.  Steroids help, no question to reduce neonatal complications but as you can see even when there is a reduction in risk for various outcomes, the number of women you need to treat to get one good outcome is quite different.

Some Discussion With Obstetrics Is Needed Here

As you read through this post you may find yourself saying “Who cares? if there is a benefit at all most moms would say give me the steroids!”  The issue here has to do with long term outcome.  To put it simply, we don’t know for this type of patient.  We know clearly that for patients at high risk of adverse outcomes eg. 24 week infant, the reduction in risks of infection, NEC, PDA, BPD etc from receiving antenatal steroids translates into many long term benefits.  What about the patient who say is 35 weeks and would have none of those risks?  Yes we are avoiding some short term outcomes that let’s be honest can be scary for a new parent but what are we trading  this benefit for.  The concern comes from what we know about steroids impact on the developing brain.  Steroids lead to a developmental arrest but in very preterm infants there is no doubt that the protective effect on all of these other outcomes more than offsets whatever impact there is there.  Incidentally I wrote about this once before and the section of interest appears at the end of the relevant post Not just for preemies anymore? Antenatal steroids for elective c-sections at term.  In the absence of these other conditions could there be a long term impact in babies 34 – 36 6/7?  My suspicion is that the answer is no but discussion is needed here especially in the absence of an endorsement by our Canadian SOGC.  Having said all that I expect the future will indeed see an expansion of the program but then I do hope that someone takes the time to follow such children up so we have the answer once and for all.

 

 

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

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

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. figure 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

Free parking to increase parental visitation

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.  table-1

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…

A blog post on well…physician bloggers

A blog post on well…physician bloggers

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
Dr. Moreno
Dr. Moreno

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. 

Copyright © 2016 American Academy of Pediatrics
Informed Refusal at 22 weeks

Informed Refusal at 22 weeks

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.

Nothing New?

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?

 

 

Overwhelmed – People are Amazing

Overwhelmed – People are Amazing

Campaign Closed October 13,2016!  Thank you everyone for the $9359.00 raised!

First off I would like to thank everyone who has contributed to the fundraiser that All Things Neonatal has organized.  Each gift no matter how small makes a difference one person at a time.  I am overwhelmed not just by the generosity of the people who follow the Facebook page and this blog but by the numbers of people that have an interest in well… All things that are neonatal!  The same day as the campaign began the Facebook page passed 10000 likes and that is saying something.  When I started I had no idea where this would go and here we are just a year and a half in and by definition we can now say goodbye to our classification as a town and consider ourselves a city having reached 10000!

With respect to the subject of generosity though I would like to make special mention and a public thank you to two very large donations that came today.  The first is from Vickar Community Chevrolet who gave $500 towards the cause.  Given that I was looking for donations as small as $1 per member on the site I consider this to be quite amazing.  It is quite inspiring to think that a company operating completely outside of the health care field still takes the time to recognize the importance of the needs of babies in our hospital.

The second “shout out” I feel the need to give is to a company that to be honest I had not heard of until today.  The company is The Nanny Company Inc who operate out of Winnipeg and I am sure would be of use to many of the families that I have discharged who themselves may find themselves in need of such help.  The Nanny Company today gave $1000 towards the fundraiser and with their donation I am proud to say we crossed the first threshold of $2000 and I am proud to announce we can officially buy one milk warmer for the NICU in Winnipeg!

By the way the Nanny Company also have a Facebook page as do Vickar Community Chevrolet so check them out to see what they do!

It is these kind of selfless acts that make me believe in the power of community.  Whether you live in Winnipeg or not it doesn’t really matter.  We all share space on this planet of ours and whether a baby is in Winnipeg, LA, Auckland or Capetown they all need our help.  With that I ask you again whether you have followed this page or not if you can spare the cost of a cheap cup of coffee and use the power that we have with 10000 members to reach our goal of at least 4 milk warmers.  If you would consider it click on this link below to Hold Their Hand and do something that you will feel great about this Weekend!

Hold Their Hand