A little cream may go a long way in reducing BPD

A little cream may go a long way in reducing BPD

 

Breast milk has many benefits and seems to be in the health care news feeds almost daily.  As the evidence mounts for long term effects of the infant microbiome, more and more centres are insisting on providing human milk to their smallest infants.  Such provision significantly reduces the incidence of NEC, mortality and length of stay.  There is a trade-off though in that donor milk after processing loses some of it’s benefits in terms of nutritional density.  One such study demonstrated nutritional insufficiencies with 79% having a fat content < 4 g/dL, 56% having protein content< 1.5 g/dL, and 67% having an energy density < 67 kcal/dL (< 20 Kcal/oz).  It is for this reason that at least in our unit many infants on donor milk ultimately receive a combination of high fluid volumes, added beneprotein or cow’s milk powders to achieve adequate caloric intake.  Without such additions, growth failure ensues.  Such growth failure is not without consequence and will be the topic of a future post.  One significant concern however is that failure of our VLBW infants to grow will no doubt impact the timing of discharge as at least in our unit, babies less than 1700g are unlikely to be discharged.  With the seemingly endless stream of babies banging on the doors of the NICU to occupy a bed, any practice that leads to increasing lengths of stay will no doubt slow discharge and cause a swelling daily patient census.

What if increasing volume was not an option?

Such might be the case with a baby diagnosed with BPD.  Medical teams are often reluctant to increase volumes in these patients due to concerns of water retention increasing respiratory support and severity of the condition.  While diuretics have not been shown to be of long term benefit to BPD they continue to be used at times perhaps due to old habits or anecdotal experiences by team members of a baby who seemed to benefit.  Such use though is not without it’s complications as the need to monitor electrolytes means more needle sticks for these infants subjecting them to painful procedures that they truly don’t need.  Alternatively, another approach is to restrict fluids but this may lead to hunger or create little room to add enough nutrition again potentially compromising the long term health of such infants.

Amy Hair and colleagues recently published the following study which takes a different approach to the problem Premature Infants 750–1,250 g Birth Weight Supplemented with a Novel Human Milk-Derived Cream Are Discharged Sooner

This paper is essentially a study within a study.  Infants taking part in an RCT of Prolacta cream (Prolacta being the subject of a previous post) were randomized as well to a cream supplement vs no cream.  The cream had a caloric density of 2.5 Kcal/mL and was added to donor milk or mother’s own milk when the measured caloric density was less than 19 Kcal/oz.  The study was small (75 patients; control 37, cream 38) which should be stated upfront and as it was a secondary analysis of the parent study was not powered to detect a difference in length of stay but that was what was reported here.  The results for the groups overall were demonstrated an impact in length of stay and discharge with the results shown below.

Control  (N=37) Cream (N=38) p
PDA ligation % 8.1 2.6 0.36
PDA treated medically % 27 29 0.85
Sepsis % 5.4 7.9 1
NEC% 0 0
BPD% 32.4 23.7 0.4
Death % 0 0
Length of stay, days 86+/-39 74+/-22 0.05
PMA at discharge, weeks 39.9+/-4.8 38.2+/-2.7 0.03

What about those with sensitivity to fluid?

Before we go into that let me state clearly that this group comparison is REALLY SMALL (control with BPD=12 vs cream with BPD=9).  The results though are interesting.

 

BPD control (N=12) BPD cream N=9 p
Length of stay, days 121 +/-49 104+/-23 0.08
PMA at discharge, weeks 44.2+/-6.1 41.3+/-2.7 0.08

So they did not reach statistical significance yet one can’t help but wonder what would have happened if the study had been larger or better yet the study was a prospective RCT examining the use of cream as a main outcome.  That of course is what no doubt will come with time.  I can’t help but think though that the results have biologic plausibility.  Providing better nutrition should lead to better growth, enhanced tissue repair and with it earlier readiness for discharge.

One interesting point here is that the method that was used to calculate the caloric density of milk was found to overestimate the density by an average of 1.2 Kcal/oz when the method was compared to a gold standard.  Given that fortification with cream was only to be used if the caloric density of the milk fell below 19 Kcal/oz where average milk caloric density is 20 Kcal/oz there is the distinct possibility that the eligible infants for cream were underestimated.  Could some of the BPD be attributable to infants being significantly undernourished in the control group as they actually were receiving <19 Kcal/oz but not fortified?  Could the added fortification have led to faster recovery from BPD?

Interesting question’s in need of answers.  I look forward to seeing where this goes.  I suspect that donor milk is not enough, adding a little cream may be needed for some infants especially those who have trouble tolerating cow’s milk fortification.

A Model For Reducing Parental Stress in the NICU.

A Model For Reducing Parental Stress in the NICU.

A good idea that is for sure and stress may be what the infant in the picture is displaying as a reflection of what her parents are feeling!  A growing trend is to include parents in rounds and that is the subject of this piece?  It sounds like a great idea and may feel that way as you have had a personal experience that has been favourable, is the practice in your unit or it just seems to make sense?  It might come as a surprise to you who have followed this blog for some time that I would even ask the question but a social media friend of mine Stefan Johansson who runs 99NICU sent an article my way on this topic. Having participated in the FiCare study I realised that  I have a bias in this area but was intrigued by the title of the paper.  The study is Parental presence on neonatal intensive care unit clinical bedside rounds: randomised trial and focus group discussion by Abdel-Latif ME et al from New Zealand and was performed due to the lack of any RCTs on the subject specifically in the NICU.

Before I go on though I have to disclose a few biases.

  1.  I love parents being on rounds so I can speak with them directly and have them ask me any questions they may have after hearing about their infants condition.
  2. Our unit encourages the practice.
  3. We are rolling out the principles of FiCare after being part of the study which encourages parental presence at the bedside for far more than just rounds.For information on implementing FiCare click here
  4. While this study is the only reported RCT on the subject in the NICU, the FiCare results will be published before long.

What is the problem with having families on rounds?

The detractors would say that sensitive information may be more difficult to discuss out in the open for fear that the family will take offence or be hurt.  Another concern may be that teaching will be affected as the attending may not want to discuss certain aspects of care in order to prevent creating fear in the parents or awkwardness in the event that the management overnight was not what they would have done.  Lastly, when patient volumes and acuity are high, having parents ask questions on rounds may lead to excessive duration of this process and lead to fatigue and frustration by all members of the team.

So what does this study add?

This particular study enrolled 72 families of which 63 completed the study.  The study required 60 families to have enough power to detect the difference in having parents on rounds or not.The design was interesting in that the randomisation was a cross over design in which the following applied.  One arm was having parents on rounds and the other without.  The unit standard at the time was to not have parents on rounds.

≤30 weeks 1 week in one arm, one week washout period then one week in the other arm

>30 weeks 3 days in one arm, three day washout and then three days in the other arm

The primary outcome was to see if there would be a significant difference in the Parental Stressor Scale.  table 3

Surprisingly there was no difference across any domains of measuring parental stress.  When we look at questions though pertaining to communication in the NICU we see some striking differences.

Table 2

The families see many benefits to the model of being on rounds.  They appear to have received more information, more contact with the team, contributed more to the planning of the course of their babies care and been able to ask more questions.  All of these things would seem to achieve the goals of having parents on rounds.

So why aren’t parents less stressed?

This to me is the most interesting part of this post.  The short answer is I am not sure but I have a few ideas.

  1.  The study could not be blinded.  If the standard of care in the unit was to not have parents on rounds, what kind of conversations happened after rounds?  Were staff supportive of the families or were they using language that had a glass is half empty feel to it?  Much like I am biased towards having parents on rounds and thanking them for their participation were there any negative comments that may have been unintentional thrown the families way.
  2. Is a little knowledge a dangerous thing?  Perhaps as families learn more details about the care of their baby it gives them more things to worry about.  Could the increase in knowledge while in some ways being pleasing to the family be offset by the concern that new questions raise.
  3. Was the intervention simply too short to detect a difference?  This may have been a very important contributor.  This short period of either a week or two leaves the study open to a significant risk that an event in either week could acutely increase stress levels.  What if the infant had to go back on a ventilator after failing CPAP, needed to be reloaded with caffeine or developed NEC?  With such short intervals one cannot say that while communication was better the parents were not stressed due to something unrelated to communication.  In an RCT these should balance out but in such a small study I see this as a significant risk.

So where do we go from here?

I applaud the authors for trying to objectively determine the effect of parental presence on rounds in the NICU.  Although I think they did an admirable job I believe the longer time frame of the FiCare study and the cluster randomised strategy using many Canadian centres will prove to be the better model to determine effectiveness.  What the study does highlight though in a very positive way is that communication is enhanced by having parents on rounds and to me that is a goal that is well worth the extra time that it may take to get through rounds.  Looking at it another way, we as the Neonatologists may need to spend less time discussing matters after rounds as we have taken care of it already.  In the end it may be the most efficient model around!

 

Parental stress in the NICU; effect of parental presence on rounds.

Parental stress in the NICU; effect of parental presence on rounds.

To many of you the answer is a resounding yes in that it reduces stress.  Why is that though?  Is it because you have had a personal experience that has been favourable, it is the practice in your unit or it just seems to make sense?  It might come as a surprise to you who have followed this blog for some time that I would even ask the question but a social media friend of mine Stefan Johansson who runs 99NICU sent an article my way on this topic. Having participated in the FiCare study I realised that  I have a bias in this area but was intrigued by the title of the paper.  The study is Parental presence on neonatal intensive care unit clinical bedside rounds: randomised trial and focus group discussion by Abdel-Latif ME et al from New Zealand and was performed due to the lack of any RCTs on the subject specifically in the NICU.

Before I go on though I have to disclose a few biases.

  1.  I love parents being on rounds so I can speak with them directly and have them ask me any questions they may have after hearing about their infants condition.
  2. Our unit encourages the practice.
  3. We are rolling out the principles of FiCare after being part of the study which encourages parental presence at the bedside for far more than just rounds.For information on implementing FiCare click here
  4. While this study is the only reported RCT on the subject in the NICU, the FiCare results will be published before long.

What is the problem with having families on rounds?

The detractors would say that sensitive information may be more difficult to discuss out in the open for fear that the family will take offence or be hurt.  Another concern may be that teaching will be affected as the attending may not want to discuss certain aspects of care in order to prevent creating fear in the parents or awkwardness in the event that the management overnight was not what they would have done.  Lastly, when patient volumes and acuity are high, having parents ask questions on rounds may lead to excessive duration of this process and lead to fatigue and frustration by all members of the team.

So what does this study add?

This particular study enrolled 72 families of which 63 completed the study.  The study required 60 families to have enough power to detect the difference in having parents on rounds or not.The design was interesting in that the randomisation was a cross over design in which the following applied.  One arm was having parents on rounds and the other without.  The unit standard at the time was to not have parents on rounds.

≤30 weeks 1 week in one arm, one week washout period then one week in the other arm

>30 weeks 3 days in one arm, three day washout and then three days in the other arm

The primary outcome was to see if there would be a significant difference in the Parental Stressor Scale.  table 3

Surprisingly there was no difference across any domains of measuring parental stress.  When we look at questions though pertaining to communication in the NICU we see some striking differences.

Table 2

The families see many benefits to the model of being on rounds.  They appear to have received more information, more contact with the team, contributed more to the planning of the course of their babies care and been able to ask more questions.  All of these things would seem to achieve the goals of having parents on rounds.

So why aren’t parents less stressed?

This to me is the most interesting part of this post.  The short answer is I am not sure but I have a few ideas.

  1.  The study could not be blinded.  If the standard of care in the unit was to not have parents on rounds, what kind of conversations happened after rounds?  Were staff supportive of the families or were they using language that had a glass is half empty feel to it?  Much like I am biased towards having parents on rounds and thanking them for their participation were there any negative comments that may have been unintentional thrown the families way.
  2. Is a little knowledge a dangerous thing?  Perhaps as families learn more details about the care of their baby it gives them more things to worry about.  Could the increase in knowledge while in some ways being pleasing to the family be offset by the concern that new questions raise.
  3. Was the intervention simply too short to detect a difference?  This may have been a very important contributor.  This short period of either a week or two leaves the study open to a significant risk that an event in either week could acutely increase stress levels.  What if the infant had to go back on a ventilator after failing CPAP, needed to be reloaded with caffeine or developed NEC?  With such short intervals one cannot say that while communication was better the parents were not stressed due to something unrelated to communication.  In an RCT these should balance out but in such a small study I see this as a significant risk.

So where do we go from here?

I applaud the authors for trying to objectively determine the effect of parental presence on rounds in the NICU.  Although I think they did an admirable job I believe the longer time frame of the FiCare study and the cluster randomised strategy using many Canadian centres will prove to be the better model to determine effectiveness.  What the study does highlight though in a very positive way is that communication is enhanced by having parents on rounds and to me that is a goal that is well worth the extra time that it may take to get through rounds.  Looking at it another way, we as the Neonatologists may need to spend less time discussing matters after rounds as we have taken care of it already.  In the end it may be the most efficient model around!

 

High Flow Nasal Cannula: Be Careful Out There

High Flow Nasal Cannula: Be Careful Out There

As the saying goes the devil is in the details.  For some years now many centres worldwide have been publishing trials pertaining to high flow nasal cannulae (HFNC) particularly as a weaning strategy for extubation.  The appeal is no doubt partly in the simplicity of the system and the perception that it is less invasive than CPAP.  Add to this that many centres have found less nasal breakdown with the implementation of HFNC as standard care and you can see where the popularity for this device has come from.

This year a contact of mine Dominic Wilkinson@NeonatalEthics on twitter (if you don’t follow him I would advise having a look!) published the following cochrane review, High flow nasal cannula for respiratory support in preterm infants.  The review as with most cochrane systematic reviews is complete and comes to a variety of important conclusions based on 6 studies including 934 infants comparing use of HFNC to CPAP.

1.  No differences in the primary outcomes of death (typical RR 0.77, 95% CI 0.43 to 1.36; 5 studies, 896 infants) or CLD.

2.  After extubation to HFNC no difference in the rate of treatment failure (typical RR 1.21, 95% CI 0.95 to 1.55; 5 studies, 786 infants) or reintubation (typical RR 0.91, 95% CI 0.68 to 1.20; 6 studies, 934 infants).

3.  Infants randomised to HFNC had reduced nasal trauma (typical RR 0.64, 95% CI 0.51 to 0.79; typical risk difference (RD) -0.14, 95% CI -0.20 to -0.08; 4 studies, 645 infants).

4. Small reduction in the rate of pneumothorax (typical RR 0.35, 95% CI 0.11 to 1.06; typical RD -0.02, 95% CI -0.03 to -0.00; 5 studies 896 infants) in infants treated with HFNC but the RR crosses one so this may be a trend at best.

If one was to do a quick search for the evidence and found this review with these findings it would be very tempting to jump on the bandwagon.  Looking at the review a little closer though there is one line that I hope many do not miss and I was happy to see Dominic include it.

“Subgroup analysis found no difference in the rate of the primary outcomes between HFNC and CPAP in preterm infants in different gestational age subgroups, though there were only small numbers of extremely preterm and late preterm infants.”

In his conclusion he further states:

Further evidence is also required for evaluating the safety and efficacy of HFNC in extremely preterm and mildly preterm subgroups, and for comparing different HFNC devices.

With so few ELBW infants included and with these infants being at highest risk of mortality and BPD our centre has been reluctant to adopt this mode of respiratory support in the absence of solid evidence that it is equally effective to CPAP in these smallest infants.  A big thank you to our Respiratory Therapy Clinical Specialist for harping on this point over the years as the temptation to adopt has been strong as other centres turn to this strategy.

Might Not Be So Safe After All

Now do not take what I am about to say as a slight against my twitter friend.  The evidence to date points to exactly what he and his other coauthors concluded but with the release of an important paper in May by Taka DK et al, I believe caution is needed when it comes to our ELBW infants.

High Flow Nasal Cannula Use Is Associated with Increased Morbidity and Length of Hospitalization in Extremely Low Birth Weight Infants

This paper adds to the body of literature on the topic as it truly focuses on the outcome of infants < 1000g.  While this study is retrospective in nature it does cover a five year period and examines important outcomes of interest to this population.

The primary outcome in this case was death or BPD and whether HFNC was used alone or with CPAP, this was more frequent than when CPAP was used alone.  Other important findings were the need for multiple and longer courses of ventilation in those who received at least some HFNC.  In these times of overburdened health care systems with goals of improving patient flow, it is also worth noting that there was a significant prolongation of length of stay with use of HFNC or HFNC and CPAP.

One interesting observation was that the group that fared the worst across the board was the combination of CPAP and HFNC rather than HFNC alone.

CPAP (941) HFNC (333) HFNC +/- CPAP (1546)
CPAP d (median, IQR) 15(5-28) 7 (1-19)
HFNC d (median, IQR) 14(5-25) 13 (6-23)
HFNC +/- CPAP 15 (5-28) 14(5-25) 26 (14-39)
BPD or death % 50.40% 56.80% 61.50%
BPD % 42.20% 52.20% 59.00%
Multiple ventiation courses 51.10% 53.10% 64.70%
More than 3 vent courses 17.60% 21.00% 29.40%
Ventilator d (median, IQR) 18(5-42) 25 (6-52) 30 (10-58)

I believe the finding may be explained by the problem inherent with retrospective studies.  This is not a study in which patients were randomized to either CPAP, HFNC or CPAP w/HFNC.  If that were the case one would expect lung pathologies and severity of illness to even ou,t such that differences between groups might be explained by the difference in treatments.  In this study though we are looking though the rearview mirror so to speak.  How could we account for the combination being worse than the HFNC alone?  I suspect it relates to the severity of lung disease.  The babies who were placed on HFNC and did well on it might have had less severe chronic changes.  What might be said about those that had the combination?  Well, one could postulate that there might be some who were extubated to HFNC and collapsed needing escalation to CPAP and then failing that therapy were reintubated.  Another explanation could be those babies who were placed on CPAP after extubation and transitioned before their lungs were ready to HFNC may have failed and lost FRC thereby going back to CPAP and possibly intubation.  Exposure in either circumstance to HFNC would therefore put them at risk of further positive pressure ventilation and subsequent further lung injury.  The babies who could tolerate transition to HFNC without CPAP might be intermediary in their outcomes (as they were found to be) as they lost FRC but were able to tolerate it but consumed more calories leaving less for growth and repair of damaged tissue leading to prolonged need for support.

Either way, the use of HFNC was found to lead to worse outcomes and in the ELBW infant should be avoided as routine practice pending the results of a prospective RCT on the subject.

Is it a total ban though?

As with many treatments that one should not consider standard of care there may be some situations where there may be benefit.  The ELBW infant with nasal breakdown from CPAP that despite excellent nursing and RRT attention continues to demonstrate tissue damage is one patient that could be considered.  The cosmetic implications and potential for surgical correction at a later date would be one reason to consider a trial of HFNC but only in the patient that was close to being able to come off CPAP.  In the end I believe that if a ELBW infant needs non invasive pressure support then it should be with CPAP but as there saying goes there may be a right time and a place for even this modality.

 

 

Point of Care Ultrasound: Changing Practice For The Better in NICU

Point of Care Ultrasound: Changing Practice For The Better in NICU

It has been some time since I wrote on the topic of point of care ultrasound (POC). The first post spoke to the benefits of reducing radiation exposure in the NICU but was truly theoretical and also was really at the start of our experience in the evolving area.  Here we are a year later and much has transpired.

We purchased an ultrasound for the NICU in one of our level III units and now have two more on the way; one for our other level III and one for our level II unit.  The thrust of these acquisitions have been to reduce radiation exposure for one but also to shorten the time to diagnosis for a number of conditions.  No matter how efficient x-ray technologists are, from the time a requisition is placed  to the arrival of the tech, placement of the baby and then processing of the film, it is much longer than using a POC at the bedside.  Having said that though is it accurate?  There are many examples to choose from but when thinking about times when one would like an answer quickly I can’t think of anything much better than a pneumothorax.

Chest X-ray vs POC for Diagnosis of Pneumothorax

The diagnosis of a pneumothorax is easily diagnosed by ultrasound when there is an absence of lung sliding as seen in this video.  In the majority of cases employing POC we are looking at ultrasound artifacts.  In the case of pleural sliding which is best described as ants marching, it’s absence indicates the presence of a pneumothorax.  The “lung point” sign as shown in this video marks the transition from pleural sliding to none and in a mode called “M” appears as a bar code when the pneumothorax is present.

Using such signs Raimondi F et al as part of the LUCI (Lung Ultrasound in the Crashing Infant) group compared traditional x-ray diagnosis as the gold standard to POC for diagnosis of pneumothorax.  This study is important as it demonstrated two very important things in the 42 infants who were enrolled in the study.  The first was the accuracy of POC.  In this study each patient had both an ultrasound and an x-ray and the results compared to determine how accurate the POC was.  Additionally in cases where there was no time for an x-ray to confirm the clinical suspicion the accuracy of the study was determined based on the finding of air with decompression along with abrupt clinical improvement.  In case people are wondering infants as small as 24 weeks were included in the study with an average weight of 1531 +/-832 g for included infants.

The accuracy was stunning with a sensitivity and specificity of 100% each.  Comparing this with clinical evaluation (transillumination, assessment of breath sounds) was far less accurate with a sensitivity of 84% (65-96) and specificity 56% (30-80).

Adding to the accuracy of the test is the efficiency of the procedure. “After clinical decompensation, lung ultrasound scans were completed in a mean time of 5.3 +/- 5.6 minutes vs a mean time of 19 +/- 11.7 minutes required for a chest radiograph (P < .001).” In short, it is very accurate and can be done quickly.  In an emergency, can you think of a better test?

If efficiency weren’t enough what about the reduction in radiation exposure?

This was the focus of a recent paper by Escourrou G & Deluca D entitled Lung ultrasound decreased radiation exposure in preterm infants in a neonatal intensive care unit. The authors in this study chose to examine retrospecitively the period from 2012 – 2014 as in 2013 they rolled out a program of teaching POC ultrasound to clinicians.  The purpose of this paper was to see if practitioners educated in interpretation of ultrasound would actually change their practice and use less ionizing radiation.

Their main findings are indicated in the table

Test 2012 2014 p
Min 1 x-ray during admission 81% 70% <0.001
Total x-rays 1976 1476
Mean x-rays per patient 4.9+/-1.5 2.6+/-1.0 <0.001
Mean radiation dose (microGy) 183+/-78 68+/-30 <0.001

As they predicted use of ionizing radiation dropped dramatically.  I should also mention that they tracked outcomes such as IVH, mortality and BPD to name a few and found no change over time.  In conclusion the use of ultrasound did not affect major outcomes but did spare each neonate ionizing radiation.

Now before anyone hits the panic button I still think the amounts of radiation here are safe for the most part.  In Canada the maximum allowed dose for the public per year is 1 mSv which is the equivalent of 1000 microGy.  This was obtained from the Nuclear Safety agency in Canada in case you are interested in finding out more about radiation safety limits.

Back in 2012 at least in this study, 2 standard deviations from the mean would have put the level received at a little over a third of what the annual limit is but it is the outliers we need to think of.  What about kids getting near daily x-rays while on high frequency ventilation or for monitoring pleural fluid collections?  There certainly are many who could receive much higher dosages and it is for those kids that I believe this technology is so imperative to embrace.

It will take time to adopt and much patience.  With any new roll out there is a learning curve.  Yes there will be learners who will need to handle patients and yes there will be studies done at times to obtain the skills necessary to perform studies in an efficient and correct manner but I assure you it will be worth it.  If we have a way of obtaining faster and accurate diagnoses and avoiding ionizing radiation don’t we owe it to our patients and families to obtain such skill?  I look forward to achieving a centre of excellence utilizing such strategies and much like this last study it will be interesting to look back in a year an see how things have changed.