Healthy at risk infants failing the infant car seat challenge.  Cause for concern?

Healthy at risk infants failing the infant car seat challenge. Cause for concern?

The infant car seat challenge(ICSC) is a test which most definitely fits the definition of a battleground issue in Neonatology.  After publishing the Canadian Pediatric Practice point on the same topic I received interesting feedback through the various social media forums that I frequent.  While some were celebrating the consensus of the statement as verification that a centres’ non practice of the test was acceptable, others seriously questioned the validity of the position.  The naysayers would point out that extremely infrequent events unless intentionally tracked may be difficult to pick up.  In the case of the ICSC, if a few patients were to suffer a hypoxic event leading to an ALTE or worse after discharge, could the ICSC have picked out these babies and prevented the outcome?  The evidence for adverse events associated with the use of car seats as discussed in the position statement is poor when using autopsy records over decades but when many clinicians can point to a failed ICSC picking up events, the thought goes that they “caught one”.  Does catching one make a difference though?

The Well Appearing Infant

Shah et al in their recent paper Clinical Outcomes Associated with a Failed Infant Car Seat Challenge attempt to address this very point.  They performed a retrospective study of 148 patients who were either <37 weeks GA or < 2500g at birth.  The study was made possible by the fact that all such infants in their hospital admitted to a well newborn area meeting these criteria by policy must have an ICSC prior to discharge.  Keep in mind that these were all infants who were on the well newborn service since they were asymptomatic.  The definition of an event in this group was one or more of pulse oximeter saturation ≤ 85% for > 10 seconds, apnea > 20 seconds, bradycardia < 80 bpm for > 10 seconds, or an apnea or bradycardia event requiring stimulation.  The failure rate was 4.5% which is very similar to other reported studies.

Why did they “fail”?

  • Failure of the ICSC was owing to desaturation 59%
  • Bradycardia 37%
  • Tachypnea 4%
  • Combination of 2 in 11%

What is interesting about these results is what happened to these infants after admission to the NICU in that 39% were identified with apnea (48% in preterm vs 17% in term infants).  These events were in the supine position which is a curious finding since the ICSC was designed to find risk of cardiorespiratory stability in a semi-recumbent position.  This has been shown previously though.

What does it all mean?

The infants in this study ultimately had more NG feeding, prolonged length of stay and septic workups after failing the ICSC that comparable infants who passed.  At first blush one would read this article and immediately question the validity of the CPS position but then the real question is what has this added to the “pool of knowledge”.  That infants may fail an ICSC at a rate of 4.5% is already known.  That such infants may demonstrate apneic events has also been shown before and a study like this may help to support those clinicians who feel it is still imperative to find these infants in order to achieve a safe discharge.  I think it is important to put these findings in the context of what would have happened if such a unit did not routinely test these types of babies.  As all were seemingly well and I presume feeding with their families, they would have been discharged after 24-48 hours to home.  We have no evidence (since they have not compared this sample to a group who did not have such testing) that if these babies were discharged they would have faired poorly.

The supporters of the ICSC would point to all the support these babies received by admitting them for 6-8 days, providing NG feeding and ruling out sepsis that they were unsafe for discharge.  The other possible way to look at it was that the infants were subjected to interventions that we have no evidence helped them.  Whether any of these infants had a positive blood culture justifying antibiotics or needed methylxanthine support is not mentioned.  Judging however by the short length of stay I suspect that none or few of these infants needed such medication as I would expect they would have stayed much longer had they needed medical treatment for apnea.

Conclusion

I do commend the authors for completing the study and while it does raise some eyebrows, I don’t see it changing at least my position on the ICSC.  While they have described a cohort of patients who failed the ICSC nicely, the fundamental question has been left unanswered.  Does any of this matter?  If you look well, are feeding well and free of any clinically recognizable events but are late preterm or IUGR can the ICSC prevent harm?  This has not been answered here and perhaps the next step would be for a centre that has abandoned the ICSC to follow their patients after discharge prospectively and see whether any adverse outcomes do indeed occur.  Any takers?

 

Parents,What Are You Worried About?

Parents,What Are You Worried About?

Throughout my career one thing has been consistently true.  That is that wherever I was working and regardless of the role I have been an educator.  I imagine the blog to a great extent is related to my interest in this aspect of my work.  In the last few years much has been said about care by parents whether it be a general approach for family centred care or in formalized approaches such as FiCare which has also been formally studied in the research setting.  When we speak of family centred care, one thing that I am constantly reminded of is that the focus of all of our efforts must be on the family and the patient.  As I said recently to a colleague when discussing what was presented as a difficult discussion with another colleague due to a disagreement about the direction of management, when you put the patient first the discussion really isn’t difficult at all.  It’s not about you or a colleagues ego but about the patient and if the management is not up to par then change direction and worry about managing egos later.

What We Know And What They Know

Another aspect that needs to be addressed is the difference in power that we have through knowledge.  I am not talking about us exerting authority over families but from the perspective of us having the knowledge from years of experience in the field as to what is significant and what is not in terms of events in the NICU.  The evidence for example with respect to neurodevelopmental outcome from apnea and bradycardia should give us reason to be optimistic the majority of the time.  While in Edmonton I learned a great deal from one of my colleagues who  was the lead author in a paper entitled Early childhood neurodevelopment in very low birth weight infants with predischarge apnea.  While frequent apnea may be associated with mild motor impairments in their paper, the predictive value of these predischarge recordings is very limited when you take away those kids without severe IVH.  I think about all of the parents we see who have their eyes glued to the monitors while they attend at the bedside and what they must be thinking.  To us it is just a matter of time but I wonder for them how agonizing a time it really is!  It isn’t just those infants who are nearing discharge and having apnea either as the CAP study  at 5 years of age showed no difference in survival without disability in those infants who received caffeine vs those who did not.  More frequent events may not be that detrimental after all.  I am not suggesting we not treat patients as one never knows where the threshold lies to cause injury but these preemies are certainly made of some tough stuff.

Identifying Stress and Preparing Parents For it

The first step in dealing with this issue is to know it is there.  Recognizing this, Melnyk and others performed an educational intervention targeting behaviour of families in their study Reducing premature infants’ length of stay and improving parents’ mental health outcomes with the Creating Opportunities for Parent Empowerment (COPE) neonatal intensive care unit program: a randomized, controlled trial.  The group of parents who went through the program had better mental health outcomes compared to the control groups.  The issue here and really is at the crux of the goal in writing all of this is that the stress that parents feel may not be overtly present.  The squeaky wheel as the saying goes gets the grease and the parents that are demonstrating signs of poor coping are the first to draw the referrals to social work or engage in a deeper conversation with nursing at the bedside.  All parents experience stress at least to a certain degree and it is all of our jobs to tease it out.  On the other hand employing standardized approaches such as the COPE program for all parents might be another way of helping those who are in need but not clearly wearing a sign on their foreheads that say “help me”.

Don’t Underestimate the Power of Reassurance

1414165926454_wps_11_Doctor_Reassuring_his_Pat.jpgSo we know that much of what we see on the monitors will not lead to long term harm, transient central cyanosis during feeds will not damage the brain and apnea of prematurity is a distinct entity from SIDS.  The parents on the other hand commonly make these links and additionally in case no one has mentioned it to you, those babies with TTN may one day develop asthma and those with hypoglycemia may have diabetes (we know both not to be true but I have been asked about this many times).  This is why I believe it is our duty to explain why we are not worried about things that come up in the unit.  Saying “don’t worry” or “that is normal preterm behaviour” may not be enough.  Ask a parent what it is they are worried about and you may be surprised to find out the links that they have made in their heads, some of which may be valid but some completely false.  I am not meaning to trivialize their concerns but rather validate them as real worries.  If we have the knowledge and it is power as I said before then shouldn’t we use that power to help reduce their stress?

Engaging Families Can Reap Huge Dividends

The movement towards family centred care and more specifically care by parent will have a dramatic impact on this issue.  As more and more centres move to engaging families to be part of rounds and not just listen and then ask questions but to take some degree of control and provide some of the reporting stress will be reduced.  It is only logical.  The more a family comes to understand what is significant and what is not in terms of reporting concerns the more confident they will be.  Moreover, spending more time at the bedside leads to more skin to skin care and with that shorter hospital stays due to better cardiorespiratory stability.  We aren’t there yet but we are headed in the right direction.  In the meantime, take the time to ask a simple question “what are you worried about” to parents no matter how confident and strong they appear and you may find yourself with an opportunity to harness the power of education you have a make a real difference to a family in need.

Towards better and safer intubation

Towards better and safer intubation

We are the victims of our own success.  Over the last decade, the approach to respiratory support of the newborn with respiratory distress has tiled heavily towards non-invasive support with CPAP.  In our own units when we look at our year over year rates of ventilation hours they are decreasing and those for CPAP dramatically increasing.  Make no mistake about it, this is a good thing.  Seeming to overlap this trend is a large increase in demand by learners as we see the numbers of residents, subspecialty trainees, nurse practitioners on the rise.  The combined effect is a reduction is the experience trainees can possibly hope to obtain when these rarer and rarer opportunities arise.  The result of all of this is that at least by my eyes (although we haven’t documented it) the number of attempts for intubations seems to be much higher than it once was.  It is not uncommon to see 3-4 attempts or sometimes more whereas in days gone by 1-2 attempts was the norm.  We do our best to deal with these shortages using simulation as an example but nothing quite compares to dealing with the real thing even if it comes close.

The Less Practice You Get The More Adverse Events You Can Expect

This is just the way it is.  Perfect practice makes perfect and it has been well documented that intubations can lead to many complications such as desaturation, bradycardia, bleeding, airway edema from multiple attempts and a host of other issues.  Hatch and colleagues first described their experience with 162 intubations in which they found adverse events in 107 (39%) with 35% being classified as non-severe and severe events in 8.8%.  Not surprisingly one of the factors associated with adverse events was the need for multiple intubation attempts.  Based on this initial experience they determined that as a unit they could do better and soon after undertook a series of PDSA Quality Improvement cycles to see if they could reduce these events and that they did.  What follows are the lessons learned from their QI project and it is my hope that some or all of these ideas may help others elsewhere who are experiencing similar frustrating rates.

Steps To A Better Intubation

The findings of their QI study were published last month in Pediatrics in their paper Interventions to Improve Patient Safety During Intubation in the Neonatal Intensive Care Unit.  The strategies they used were threefold.

  1. Standardized checklist before intubation – This used a “do-confirm” approach in which the individuals on the team “do” what they need to prepare and then confirm with the group that they are done.  An example might be an RRT who states “I have three sizes of ETT ready with a stylet already inserted, surfactant is thawed and the ventilator is set with settings of … if needed etc”.  Another critical part of the checklist includes ensuring that everyone knows in advance their roles and who is responsible for what.
  2. Premedication algorithm – Prior to this project the use of premedication was inconsistent, drug selection was highly varied and muscle relaxation was almost non-existent.  The team identified from the literature that a standard approach to premedication had been associated with reductions in adverse events in other centres so adopted the same here using fentanyl with atropine if preterm and muscle relaxation optional.
  3. Computerized order set for intubation – interestingly the order set included prompts to nursing to make sure intervention 1 and 2 were done as well.

The results of there before and after comparison were numerous but I have summarized some of the more important findings in the table below.

Outcome Period 1 (273 intubations) Period 2 (236 intubations) p
Any AE 46.2% 36.0% 0.02
Severe events 8.8% 6.4% 0.04
Bradycardia 24.2% 9.3% <0.001
Hypoxemia 44.3% 33.1% 0.006
Esophageal intubation 21.3% 14.4% 0.05
# attempts 2 2 NS
<10 intubations experience 15.1% 25.5% 0.001

The median number of attempts were no different but the level of experience in the second epoch was less.  One would expect with less experienced intubators this would predict higher risk for adverse events.  What was seen though was a statistically significant reduction in many important outcomes as listed in the table.  I can only speculate what the results might have been if the experience of the intubators was similar in the first and second periods but I suspect the results would have been even more impressive.  The results seem even more impressive in fact when you factor in that the checklist was used despite all of the education and order set 73% of the time and muscle relaxation was hardly used at all.  I believe though what can be taken out of these results is that taking the time to plan each intubation and having a standard approach so that all staff practice in the same way reaps benefits.  If you already do this in your unit then congratulations but if you don’t then perhaps this may be of use to you!

What About Intubation For INSURE?

We are in the process of looking in our own centre at the utility of providing premedication when planning to give surfactant via the INSURE technique.  I couldn’t help but notice that this paper also looked at that very issue.  Their findings in 17 patients all of whom were provided premedication were that only one could not be extubated right after surfactant.  The one who was not extubated however was kept intubated for several hours without any reasoning provided in the records so it may well be that the infant could have been electively kept ventilated when they may have indeed been ready for extubation.  The lesson here though is that we likely do not need to exclude such patients from premedication it will reduce the likelihood of complications without prolonging the time receiving positive pressure ventilation.

Whatever your thoughts may be at this time one of the first questions you should ask is what is our local rate of complications?  If you don’t know then do an audit and find out.  Whatever the result, shouldn’t we all strive to lower that number if we can?

A Cure For Neonatal Hypoglycemia

A Cure For Neonatal Hypoglycemia

I have probably received more requests for our glucose gel protocol than any other question since I started writing on this blog.  Dextrose gel has been used more and more often for treatment of hypoglycemia such that it is now a key strategy in the management of low blood sugar in ours and many other institutions.  If you are interested in the past analyses of the supporting trials they can be found in these posts; Glucose gel For Managing Hypoglycemia. Can We Afford Not To Use It? and Dextrose gel for hypoglycemia: Safe in the long run?  As you can tell from these posts I am a fan of dextrose gel and eagerly await our own analysis of the impact of using gel on NICU admission rates for one!

But What If You Could Prevent Hypoglycemia Rather Than Treating It?

This is the question that the same group who has conducted the other trials sought to answer in their dose finding study entitled Prophylactic Oral Dextrose Gel for Newborn Babies at Risk of Neonatal Hypoglycaemia: A Randomised Controlled Dose-Finding Trial (the Pre-hPOD Study).  I suppose it was only a matter of time that someone asked the question; “What if we prophylactically gave at risk babies dextrose gel?  Could we prevent them from becoming hypoglycemic and reduce admissions and improve breastfeeding rates as has been seen with treatment of established hypoglycemia?”  That is what they went out and did.  The group selected at risk patients such as those born to mothers with any type of diabetes, late preterm infants, SGA and others typically classified as being at risk but who did not require NICU admission at 1 hour of age when treatment was provided.  The primary outcome was hypoglcyemia (<2.6 mmol/L) in the first 48 hours.  Secondary outcomes included NICU admissions, breastfeeding rates in hospital and after discharge as well as formula intake at various time points.

The study sought really to serve as a pilot whose goal was to determine when compared to placebo whether several different regimens could prevent development of hypoglycemia.  The groups were (with the first dose in each case given at 1 hour of age):

  1. Single dose of 40% dextrose gel – 0.5 mL/kg
  2. Single dose of 40% dextrose gel – 1 ml/kg
  3. Four doses of 0.5 mL/kg given every three hours with breastfeeding
  4. A single dose of 1 mL/kg then 3 X 0.5 mL/kg given q3h before each breastfeed.

In total 412 patients were randomized into 8 different groups (4 treatment and 4 placebo).

As The Saying Goes, Less Is More

odds-of-hypoglycemia

The only dose of dextrose that reduced the risk of hypoglycemia in the first 48 hours was 0.5 mL/kg which provides 200 mg/kg of dextrose which is the same as a bolus of IV dextrose when giving 2 mL/kg of D10W.  Curiously using a higher dose or using multiple doses had no effect on reducing the risk.  Based on a difference of 14% between placebo and this group you would need to treat roughly 7 patients with dextrose gel once to prevent one episode of hypoglycemia.  Also worth noting is that admission to NICU was no different but if one restricted the reason for admission to hypoglycemia the difference was significant (13% vs 2% risk; p = 0.04).  What was not seen here was a difference in rates of breastfeeding and much effect on use of formula.

Why Might These Results Have Occurred?

Insulin levels were not measured in this study but I truly wonder if the reason for hypoglycemia in the other groups may have been transient hyperinsulinemia from essentially receiving either a very large load of glucose (1 mL/kg groups) or effectively 4 boluses of glucose in the first 12 hours of feeding.  Rebound hypoglycemia from IV boluses is a known phenomenon as insulin levels surge to deal with the large dextrose load and I can’t help but wonder if that is the reason that all but the single dose regimen had an effect.  It is also worth commenting that with so many secondary outcomes in this study the p values needed to reach significance are likely much smaller than 0.05 so I would take the reduction in NICU admissions for hypoglycemia with a grain of salt although at least the trend is encouraging.

I wouldn’t change my practice yet and the authors do acknowledge in the article that a much larger study is now being done using the single dose of 0.5 mL/kg to look at outcomes and until that is published I don’t think a practice change is in order.  What this study does reinforce though is that providing multiple doses of dextrose gel may yield diminishing returns.  While the goal here was prophylaxis, I can’t help but think about the patients who are symptomatic and receive two or three gels and still wind up with an IV.  Could it be the same rebound hypoglycemia at play?

We also have to acknowledge that even if this is an effective preventative strategy, is it in the best interests of the babies to all receive such treatment when at least in 6 babies they wouldn’t have needed any?  Could such treatment simply be reserved as has been done for those who develop hypoglycemia?  Those who question the safety of the ingredients such as dyes that are found in the product may want some long term safety data before this becomes routine in at risk babies but it won’t surprise me if such strategies become commonplace pending the results of the larger trial on the way.

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…