Can prophylactic dextrose gel prevent babies from becoming hypoglycemic?

Can prophylactic dextrose gel prevent babies from becoming hypoglycemic?

I have written a number of times already on the topic of dextrose gels. Previous posts have largely focused on the positive impacts of reduction in NICU admissions, better breastfeeding rates and comparable outcomes for development into childhood when these gels are used. The papers thus far have looked at the effectiveness of gel in patients who have become hypoglycemic and are in need of treatment. The question then remains as to whether it would be possible to provide dextrose gel to infants who are deemed to be at risk of hypoglycemia to see if we could reduce the number of patients who ultimately do become so and require admission.

Answering that question

Recently, Coors et al published Prophylactic Dextrose Gel Does Not Prevent Neonatal Hypoglycemia: A Quasi-Experimental Pilot Study. What they mean by Quasi-Experimental is that due to availability of researchers at off hours to obtain consent they were unable to produce a randomized controlled trial. What they were able to do was compare a group that had the following risk factors (late preterm, birth weight <2500 or >4000 g, and infants of mothers with diabetes) that they obtained consent for giving dextrose gel following a feed to a control group that had the same risk factors but no consent for participation. The protocol was that each infant would be offered a breastfeed or formula feed after birth followed by 40% dextrose gel (instaglucose) and then get a POC glucose measurement 30 minutes later. A protocol was then used based on different glucose results to determine whether the next step would be a repeat attempt with feeding and gel or if an IV was needed to resolve the issue.

To be sure, there was big hope in this study as imagine if you could prevent a patient from becoming hypoglycemic and requiring IV dextrose followed by admission to a unit.  Sadly though what they found was absolutely no impact of such a strategy.  Compared with the control group there was no difference in capillary glucose after provision of dextrose gel (52.1 ± 17.1 vs 50.5 ± 15.3 mg/dL, P = .69).  One might speculate that this is because there are differing driving forces for hypoglycemia and indeed that was the case here where there were more IDMs and earlier GA in the prophylactic group.  On the other hand there were more LGA infants in the control group which might put them at higher risk.  When these factors were analyzed though to determine whether they played a role in the lack of results they were found not to. Moreover, looking at rates of admission to the NICU for hypoglycemia there were also no benefits shown.  Some benefits were seen in breastfeeding duration and a reduction in formula volumes consistent with previous studies examining the effect of glucose gel on both which is a win I suppose.

It may also be that when you take a large group of babies with risks for hypoglycemia but many were never going to become hypoglycemic, those who would have had a normal sugar anyway dilute out any effect.  These infants have a retained ability to produce insulin in response to a rising blood glucose and to limit the upward movement of their glucose levels.  As such what if the following example is at work? Let’s say there are 200 babies who have risk factors for hypoglycemia and half get glucose gel.  Of the 100 about 20% will actually go on to have a low blood sugar after birth.  What if there is a 50% reduction in this group of low blood sugars so that only 10 develop low blood glucose instead of 20.  When you look at the results you would find in the prophylaxis group 10/100 babies have a low blood sugar vs 20/100.  This might not be enough of a sample size to demonstrate a difference as the babies who were destined not to have hypoglycemia dilute out the effect.  A crude example for sure but when the incidence of the problem is low, such effects may be lost.

A Tale of Two Papers

This post is actually part of a series with this being part 1.  Part 2 will look at a study that came up with a different conclusion.  How can two papers asking the same question come up with different answers?  That is the story of medicine but in the next part we will look at a paper that suggests this strategy does work and look at possible reasons why.

Screening for congenital heart disease; will early discharge be its ruin?

Screening for congenital heart disease; will early discharge be its ruin?

In 2017 the Canadian Pediatric Society published the practice point Pulse oximetry screening in newborns to enhance detection of critical congenital heart disease.  In this document we recommended universal screening for CCHDs but stressed the following:

“Recognizing that delivery and time of discharge practices vary across Canada, the timing of testing should be individualized for each centre and (ideally) occur after 24 hours postbirth to lower FP results. And because the intent is to screen newborns before they develop symptoms, the goal should be to perform screening before they reach 36 hours of age.”

This recommendation was put in place to minimize the number of false positive results and prevent Pediatricians and Cardiologists nationwide from being inundated with requests to rule out CCHD as earlier testing may pick up other causes for low oxygen saturation such as TTN.  The issue remains though that many patients are indeed discharged before 24 hours and in the case of midwife deliveries either in centres or in the home what do we do?

A Population Study From the Netherlands May Be of Help Here

Researchers in the Netherlands had a golden opportunity to answer this question as a significant proportion of births occur there in the home under the care of a midwife. Accuracy of Pulse Oximetry Screening for Critical Congenital Heart Defects after Home Birth and Early Postnatal Discharge by Ilona C. Narayen et al was published this month in J Peds. About 30% of births are cared for by a midwife with about 20% occurring in the home. The authors chose to study this population of infants who were all above 35 weeks gestation and not admitted to an intensive care nor had suspicion of CCHD prior to delivery. The timing of the screening was altered from the typical 24-48 hours to be two time points to be more reflective of midwives practice. All patients were recruited after birth with the use of information pamphlets. The prospective protocol was screening on 2 separate moments: on day 1, at least 1 hour after birth, and on day 2 or 3 of life. The criteria for passing or failing the test are the same as those outlined in the CPS practice point. As part of the study, patients with known CCHDs were also screened separately as a different group to determine the accuracy of the screening test in patients with known CCHD.

Results

There were nearly 24000 patients born during this period. Only 49 cases of CCHD were identified by screening and of these 36 had been picked up antenatally giving a detection rate of 73%. Out of 10 patients without prenatal diagnosis who also had saturation results available the detection rate was 50%. Three of the misses were coarctation of the aorta (most likely diagnosis to be missed in other studies), pulmonary stenosis (this one surprises me) and TGA (really surprises me). The false-positive rate of pulse oximetry screening (no CCHD) was 0.92%. The specificity was over 99% meaning that if you didn’t have CCHD you were very likely to have a negative test. Not surprisingly, most false- positives occurred on day 1 (190 on day 1 vs 31 infants on day 2 or 3). There were five patients missed who were not detected either by antenatal ultrasound. These 5 negatives ultimately presented with symptoms at later time points and all but one survived (TGA) so out of 24000 births the system for detecting CCHD did reasonably well in enhancing detection as they picked up another 5 babies that had been missed antenatally narrowing the undetected from 10 down to 5.

Perhaps the most interesting thing about the study though is what they also found. As the authors state: “Importantly, 61% (134/221) of the infants with false-positive screenings proved to have significant noncardiac illnesses re- quiring intervention and medical follow-up, including infection/ sepsis (n = 31) and PPHN or transient tachypnea of the newborn (n = 88)”

There are certainly detractors of this screening approach but remember these infants were all thought to be asymptomatic. By implementing the screening program there was opportunity to potentially address infants care needs before they went on to develop more significant illness. Under appreciated TTN could lead to hypoxia and worsen and PPHN could become significantly worse as well. I think it is time to think of screening in this way as being more general and not just about finding CCHD. It is a means to identify children with CCHD OR RESPIRATORY illnesses earlier in their course and do something about it!

 

Magnetic acupuncture coming to an NICU near you?

I would consider myself fairly open minded when it comes to care in the NICU.  I wouldn’t call myself a maverick or careless but I certainly am open to new techniques or technologies that may offer a better level of care for the babies in our unit.  When it comes to “non-Western” concepts though such as therapeutic touch, chiropractic manipulations of infants and acupuncture (needle or otherwise) I have generally been a skeptic.  I have written about such topics before with the most popular post being Laser acupuncture for neonatal abstinence syndrome.  My conclusion there was that I was not a fan of the strategy but perhaps I could be more open to non traditional therapies.

Magnetic Acupuncture

This would appear to be the newest and perhaps strangest (to me at least) approach to pain relief that I have seen.  I do love name of this study; the MAGNIFIC trial consisted of a pilot study on the use of auricular magnetic acupuncture to alleviate pain in the NICU from heel lances.  The study was published in Acta Paediatrica this month; Magnetic Non-Invasive Acupuncture for Infant Comfort (MAGNIFIC) – A single-blinded randomized controlled pilot trial.  The goal here was to measure pain scores using the PIPP scoring system for pain in the neonate before during and after a painful experience (heel lance) in the NICU.  Being a pilot study it was small with only 20 needed per arm based on the power calculation to detect a 20% difference in scores.  The intervention used small magnets placed at specific locations on the ear of the infant at least two hours before the heel lance was to occur.  Before I get into the results, the authors of the study provide references to explain how the therapy works.  Looking at the references I have to admit I was not able to obtain complete papers but the evidence is generally it would appear from adult patients.  The explanation has to do with the magnetic field increasing blood flow to the area the magnet is applied to and in addition another reference suggests that there are affects the orbitofrontal and limbic regions which then impacts neurohormonal responses as seen in functional MRI.  The evidence to support this is I would have thought would be pretty sparse but I was surprised to find a literature review on the subject that looked at 42 studies on the topic.  The finding was that 88% of the studies reported a therapeutic effect.  The conclusion though of the review was that the quality of the included studies was a bit sketchy for the most part so was not able to find that this should be a recommended therapy.

So what were the results?

Despite my clear skepticism what this study did well was that aside from the magnets, the intervention was the same.  Twenty one babies received the magnetic treatments vs 19 placebo.  There was a difference in the gestational ages of the babies with the magnet treated infants being about two weeks older (35 vs 33 weeks).  What difference that might in and of itself have on the PIPPs scoring I am not sure.  The stickers were applied to the ears with and without magnets in a randomized fashion and the nurses instructed to score them using the PIPP scoring system.  Interestingly, as per their unit policy all babies received sucrose as well before the intervention of a heel lance so I suppose the information gleaned here would be the use of magnets as an adjunctive treatment.  No difference was noted in the two groups before and after the heel lance but during the procedure the magnet treated infants had a difference in means (SD): 5.9 (3.7) v 8.3 (4.7), p=0.04).  No differences were found in secondary measures such as HR or saturation and no adverse effects were noted.  The authors conclusions were that it was feasible and appears safe and as with most pilot studies warrants further larger studies to verify the results.

Should we run out and buy it?

One of the issues I have with the study is that in the introduction they mention that this treatment might be useful where kangaroo care (KC) is not such as a critically ill infant.  Having placed infants who are quite sick in KC and watched wonderful stability arise I am not sure if the unit in question under utilizes this important modality for comfort.

The second and perhaps biggest issue I have here is that although the primary outcome was reached it does seem that there was some fishing going on here.  By that I mean there were three PIPP scores examined (before, during and after) and one barely reached statistical significance.  My hunch is that indeed this was reached by chance rather than it being a real difference.

The last concern is that while the intervention was done in a blinded and randomized fashion, the evidence supporting the use of this in the first place is not strong.  Taking this into account and adding the previous concern in as well and I have strong doubts that this is indeed “for real”.  I doubt this will be the last we will hear about it and while my skepticism continues I have to admit if a larger study is produced I will be willing and interested to read it.

You don’t plan to fail. You fail to plan

You don’t plan to fail. You fail to plan

I am fortunate to work with a group of inter-professionals who strive for perfection.  When you connect such people with those with skills in multimedia you create the opportunity for education.  I can’t say enough about the power of education and moreover the ability to improve patient outcomes when it is done well.

With this post I am going to be starting to share a collection of videos that I will release from time to time.  The hope with any release like this is that you the reader wherever you are may find some use from these short clips.  My thanks to the team that put these together as the quality is beyond compare and the HD quality is great for viewing on any device.

Placing A Chest Tube Can Be A Difficult Thing

As I said to a colleague in training the other day, a chest tube may seem daunting but once you see how it is done it loses some of its intimidation.  Having said that, once you see it placed it can be a long time between opportunities for you to view another.  That is where having a repository of videos comes in that you can watch prior to the next opportunity.  These very short clips are easy to access when needed and may calm the nerves the next time you are called to place a chest tube.

A Word About Chest Tubes

The videos in question demonstrate how to place a Thal quick chest tube. In case this looks foreign to you it may be because you are using the older generation style of chest tubes that come equipped with a trocar.  Even without the use of the trocar, these rigid tubes carry a significant risk of lung laceration or other tissue injury.  For a review of such complications related to chest tube insertion see Thoracostomy tubes: A comprehensive review of complications and related topics.

The jury as they say is still out with respect to the use of these softer chest tube sets.  There is no question that they are easier to place than the traditional thoracostomy tube.  Their pliability though does carry a significant risk of kinking or blockage as we have seen in some patients when the Thal chest tube set is used to drain fluid in particular.  Less of an issue with air leaks.

Start of a series

This post I suppose marks a slightly new direction for the blog.  While I thoroughly enjoy educating you with the posts about topics of interest I see an opportunity to help those who are more visual in their learning.  The videos will be posted over the next while with accompanying written posts such as this.  They can be accessed on my Youtube channel at

All Things Neonatal YouTube

To receive regular updates as new videos are added feel free to subscribe!

Lastly a big thank you to NS, RH and GS without whom none of this would have been possible!

Quality Improvement: The Next Frontier in Neonatology

Quality Improvement: The Next Frontier in Neonatology

The giant leaps in Neonatology may for the most part be over.  So many outstanding research trials have brought us to where we are today.  The major innovations of surfactant replacement, the discovery of nitric oxide and its later use to treat pulmonary hypertension, caffeine for apnea have all changed our field for the better.  Cooling for HIE has certainly changed my practice in that I now truly have no idea what to tell parents after even some of the worst cases of asphyxia as our team has witnessed “miracles”after cooling.  What will come next?  My bet is that we are about to enter the era of Quality Improvement more and more.  Think about the last study you read that had a major change in your practice or better yet made a substantial change in survival or neurodevelopmental outcome.

Tweaking care is where its at.

I like to think of it as fine tuning.  fine-tuningAs the era of the major leaps in care seems to be passing us by what I see more and more are studies looking at how to make further improvements on what we already know.  In some cases such as using higher doses of caffeine may reduce the incidence of apnea further compared to standard dosing while cooling for 96 hours instead of 72 and at lower temperatures after asphyxia may not be such a good idea after all.  There will be some studies that suggest a modification of practice and then others that suggest we should look elsewhere for further improvements.  With all of this evidence coming out in hundreds if not thousands of journals every week it is difficult to keep up and it may be that our focus is in need of a change in direction or at least devoting members of the team to look at something different.

That Focus Is On Quality Improvement (QI)

Before I go on I don’t want to insinuate that I am something that I am not.  I do not have any formal training in QI and consider myself an amateur but I do understand enough to undertake a PDSA cycle and see where it takes me.  pdsaTo me QI is about finding ways to actually make your best practices the best they can be.  Take for example our units goal to minimize needle pokes by carefully examining the usefulness of common tests that we perform.  Add to this the recent implementation of non invasive technology such as transcutaneous bilirubin metres which our evidence suggests can reliably replace a serum sample to screen for those in need of phototherapy.  While I commonly like to praise our team for its ability to critically think about needed bloodwork it was only through the collection of data using audit tools that we discovered we had a problem.  The problem was that the rate of CBC samples that were clotting were unacceptably high at over 30%.  This was compared to another NICU in the same city that had a rate of less than 1/3 that.  The initial reaction since it was trained lab personnel collecting at the low clotting site vs nursing at the high rate site was that the solution was simple.  Just change back to lab personnel (as it used to be) at the high rate site!  Ah but that would create another problem.  Other evidence used to build a care plan for our preterm infants suggested that clustering of care was better for them than poking them at the usual run time of the lab techs so we had a conflict.  How did we solve it?  We resisted our urge for the quick fix and entered into a formal QI project.

How did we do it and what were the results?

It took us four rounds of PDSA cycles but in the end we found a solution that has lasted.  As I write this I learned that one of our two units that had the high rates set a record low this past month of a 4.9% clotting rate even lower than the comparative site that began with a low clotting rate.  It took work and was by no means easy but the dedication of our nurse educator to the task made all the difference.  Fortunately, for those who don’t know where to begin an incredible resource is available from BMJ Quality Improvement who provide a step by step process to carry out your project.  Moreover after using their template for publishing such work, we were able to publish our work which we hope may be of help for other centres that find themselves in a similar situation.  Perhaps the solution might be the same or at least similar enough to try one of our interventions?  The full paper can be found at the end of the post but the trend over time is so impressive that I felt obliged to show you the results.Clotting PDSA Graph Median_Trendline

Why should you care?

Teams spend so much time rolling out new evidence based initiatives.  All the evidence in world won’t help if the intervention isn’t achieving the results you expect.  How will you know unless you audit your results?  You may be surprised to find that what you expected in terms of benefit you aren’t seeing.  By applying the principals of QI you may find you don’t need to look for another treatment or device but rather you simply need to change your current practice.  9780060545789_custom-b5f01806d4ecf9181bfa5dca982f2b0fd22dca4d-s400-c85A little education and direction may be all that is needed.  You may also find to your surprise that what you thought everyone was doing is not what they are doing at all.
Resist the quick solution and put in the time to find the right solution.  As Carl Honore suggests slowing things down may be the best thing for all of us and more importantly the patients we care for.

Link to the full article:

Reducing CBC Clotting Rates in the Neonatal Patient Care Areas

References

  1.  Mohammed S et al. High versus low-dose caffeine for apnea of prematurity: a randomized controlled trial. Eur J Pediatr 2015 Jul;174(7):949-56.
  2. Shankaran S et al. Effect of depth and duration of cooling on deaths in the NICU among neonates with hypoxic ischemic encephalopathy: a randomized clinical trial.JAMA 2014 Dec 24-31;312(24):2629-39