A step forward in neonatal resuscitation. And Oh So Simple.

Posted on 27 October 2015 by Keith Barrington

When you are resuscitating a baby, and you ask, how is the heart rate? What kind of answer do you get? “It’s good” “pulse is a bit slow” “I think its around 80”?

As Lou Halamek and his team recount (Yamada NK, et al. Impact of Standardized Communication Techniques on Errors during Simulated Neonatal Resuscitation. American journal of perinatology. 2015), such kinds of communication in an Air Traffic Control tower would see you booted out. In air traffic control, they realized that imprecise, or even just variable, ways of recounting what was going on, were leading to errors; so now, when there is a communication, it has to follow a strict format. Yamada et al have followed that lead and developed a standard lexicon of information transfer for neonatal resuscitation, including a closed-loop communication system for completing orders for medication or volume resuscitation.

In answer to the question above, the responses have to be one of the following “heart rate above 100″; ‘heart rate below 100”; “heart rate below 60”; or “we’re in deep shit’ (I made that last one up, it should be “heart rate zero”).

You can see how that would be better than “I can’t hear a heart rate” which might mean, “I have a middle ear infection”, or “my stethoscope just dropped on the floor”, or “the baby is asystolic”!

Similar structured phrases are presented for other issues during resuscitation.

For medications or volume, the order must include the name of medication, dose, concentration and route AND it must be repeated by the person taking the order and include all the same information.

They studied this in an RCT, with nurses trained in the lexicon. A cross-over design was used, so the trained nurses either used the lexicon or did not, and 13 people with some experience in NRP were enrolled as the study subjects.

This is a weakness in design of this study,  I think, the trained nurses were told for the control group to “follow the general pattern of imprecise communication that is typical of nonstandardized speech”. It is certainly possible that the nurse participants, who were probably invested in showing that this works, might have used even more imprecise phrases than usual. I don’t remember ever hearing “wow he’s crackly” (one of their examples) when asking about air entry, but I guess the point is that it could happen. I think it would have been better to use non-trained nurses as the controls, but I can see that would introduce other biases also.

The other problem is that although this seems like a major, and very obvious, improvement (although I didn’t think about it), the sample size was so small that most of the changes seen were not that significant. There were fewer errors of omission (failure to perform an intervention that was clinically indicated), cardiac compressions were started earlier, by about 8 seconds, PPV was started earlier by about 2 seconds. Communication techniques were used much more frequently; that comparison was statistically significant.

This is another place where I am not sure we need another trial; we should probably all start doing this, making sure communication is clear, by using standard phrases. I can’t see any down side, it wouldn’t cost anything, and the only thing a larger study is likely to find is that sometimes communication errors lead to screw ups.

Posted in Neonatal Research | Tagged | 1 Comment

Also, still no parents!

Posted on 27 October 2015 by Keith Barrington

My previous post was long enough without addressing another serious deficiency in these guidelines. It is worth its own post.

The guidelines are written by doctors. And only doctors (actually only Obstetricians). There is no input mentioned from any other stakeholders.

Most importantly no parents.

Surely the time has come to stop doing this, to stop physicians gathering in closed rooms and deciding what is best for the rest of the population. This is not a new idea, it has been strongly recommended for many years. The Institute of Medicine published guidance 4 years ago (to my mind their guidance leaves the patient/parent out of the process until too late) about involving patients/parents in the guideline development process. There are very high profile editorials in leading journals. There are even blog posts about it!

So why are bodies like ACOG and the SMFM not doing this? Is it because they may not like what they would hear? Is it easier to meet around a table with other physicians and not be challenged by a patient? Is it even easier if you limit the physicians to just your Obstetrical colleagues?

One of the reasons identified for why clinical practice guidelines have little effect on practice is the lack of involvement of the people most affected by them.

Because that is the whole point. The Obstetrician will leave work at the end of the day to go home, the families are marked forever by these decisions. Whichever way they go.

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Another extremely flawed guideline on periviable deliveries

Posted on 26 October 2015 by Keith Barrington

Oh Dear, here we go again…

This is a joint statement from ACOG and the SMFM. There is some good in here, but you’d think they could at least get the facts right.

“Delivery before 23 weeks of gestation typically leads to neonatal death irrespective of newborn resuscitation (5-6% survival)”.

This is just nonsense. What does this mean, that if you don’t resuscitate you will get the same survival as if you do? Survival is 0% without resuscitation and between 21 and 40% if you do. What is the point of mixing figures from patients with active treatment, and those without? So that you can say to an expectant mother, “in a mixed group of infants, some of whom received active care and others did not, (but we aren’t going to tell you how many) 5 to 6% survived”?

The references they give for that percentage show what can happen if you provide active treatment. Survival in Stoll BJ, 2010 at 22 weeks was 21%, in Rysavy et al it was 23%, among actively treated infants. Other figures show similar things in even more detail. The EXPRESS group in Sweden have been leaders in this, their article in JAMA in 2009 shows that in 51 infants of 22 weeks (there were 2 babies of slightly less than 22 weeks included) there were 19 who were admitted to the NICU for active care, 5 survived, or 26%. Including the infants who were born alive but not resuscitated decreases the survival to 9%, but telling a mother that the risk of survival is 9% makes no sense at all.

You can only give informed consent if you have not been misinformed! The chance of survival is either 0 or 26% from those figures.

I was recently “accused” in a public meeting of wanting to resuscitate 100% of live born babies. Which is untrue. But I do want 100% of mothers to be able to make decisions based on accurate information, based on sensitive personalized counselling. To make decisions that are best for them and their family, which they cannot make unless they really know what the options are. Which means good data.

Lets return to the statement, and another inaccurate piece of information:

“Among rare survivors significant morbidity is universal (98-100%)”.

Although morbidity is not defined here, I presume this is referring to adverse long-term outcomes, as they are the only things discussed in this statement. If so it is a gross exaggeration, the 2 references given show no such thing. Rysavy et al showed 61.1% ‘significant morbidity among survivors’ and Stoll et al contains no data on long term outcomes. It does show that all infants born at 22 weeks are sick, which should be no surprise, and surely should not be confused with data about long term neurological and developmental prognosis.

In fact Rysavy et al’s paper is grossly misquoted in Figure 2. The percentages shown are completely wrong.

Also it is ridiculous to mix together, in Figure 2 the following :

Greg Moore’s systematic review of outcomes at 4 to 8 years which defined moderate and severe impairment as an IQ less than 70 and Cerebral Palsy with a GMFCS of 2 or worse.

Rysavy et al’s data which examined babies at 18 to 22 months and defined moderate and severe impairment as a Bayley3 less than 85 and CP with a GMFCS of 2 or worse

Two publications with data from different tests at 2 different ages from the original EpiCure dataset. Marlow 2006, for example, defined severe disability as a cognitive score less than 70 and non-ambulatory CP, at 6 years of age.

Ishii from Japan, who at 3 years defined profound impairment as cognitive score less than 50 or “profound CP”

What possible use is a figure that mixes all those together, and then completely misses the mark with one study (Rysavy) by showing outcomes among all babies delivered, including those who were not offered intensive care.

This is another statement that should be junked. At least get your literature review right first. Then you can start on the value-laden judgements about when to intervene.

And if the whole point is to make an individual decision, based on the families values and interests (which is the message being given by tables 1 and 2), then why on earth do you need the completely inconsistent table 3? Table 3 which then goes back to the standard old-fashioned approach making decisions according to completed weeks of gestation. So for example antenatal corticosteroids are “Not recommended” up to 22 weeks and 6 days, but you can consider them at 23 weeks and 0 days, up to 23 weeks and 6 days, when one day later they become recommended.

How “Not recommended” was graded as a recommendation 1A which means, according to their system “strong recommendation, high-quality evidence”, is completely beyond me. What evidence is there of harm? Which is what you need according to their own framework to make that statement. Their own brief review shows no harm, although there is no proof of major benefit at 22 weeks, and suddenly at 23 weeks and 0 days there is a reduction in death, severe IVH, NEC and PVL.

It should be “strong recommendation, entrenched prejudice”.

The best you can really say is that whether or not steroids help at 22 weeks is uncertain, and there is currently no evidence of harm. An honest evaluation of the literature should lead to a recommendation of “we don’t know”. Which would mean discuss this with the mother.

Which is really what a statement regarding counselling should be all about. How to understand the evidence, the limitations of the evidence, how to explore the values, hopes and desires of a woman in distress, and her partner if there is one. How to come to a decision that is within the bounds of what is reasonable, and to take into account the interests of the baby.

I started off this post by saying that there is some good here. I think that many of the issues addressed in those first 2 tables are spot on. There is a recognition of the poor accuracy of gestational age assessment, a brief note regarding the limitations of survival figures, an acknowledgement that there is no good evidence that antenatal risk calculators affect decision-making or improve satisfaction. There are some general recommendations about how where and by whom counselling should be done, and about taking into account other factors than gestational age which alter outcomes. They then seem to ignore most of their own advice in table 3.

My main issue is that to make a blanket recommendation for all women at 23 weeks and 4 days, or at 22 weeks and 3.24 days, is inconsistent with good medical practice, and is inconsistent with the initial paragraphs and the first 2 tables. After recognizing the limitations in the evidence, the limitations in gestational age assessment, the uncertainty of other risks, and the variations in individual values and preferences, then steroids may or many not be a reasonable intervention for a particular mother (for example).  To say that would be much more useful, I think than, at 24 weeks and 0 days do X (or consider X, or don’t do X). It might not make things cut and dried and easy for the Obstetrician, or MFM specialist, but it ain’t supposed to be easy. Oh and next time talk to a neonatologist, someone who understands a bit about perinatal epidemiology, and someone who understands about long term follow-up.

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Life in a hospital…

Posted on 26 October 2015 by Keith Barrington

My nephew Charles has a youtube channel that I directed readers to previously, I really like his funny recent video `life in a hospital‘ but I hesitated to publish a link here. There are some stereotypical nurse images that might be misinterpreted by some of my esteemed nursing colleagues.

I truly understand that response, but on the other hand, maybe, in his current situation (he is practically living in the hospital) we can cut him some slack. Maybe this most recent video ‘how to tell someone that you have CF‘ will help us all to understand a bit.

 

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Another confirmation of the excellent quality of life of very preterm infants

Posted on 22 October 2015 by Keith Barrington

Huhtala M, et al. Health-related quality of life in very low birth weight children at nearly eight years of age. Acta Paediatrica. 2015

This study from Finland showed an excellent quality of life of former VLBW infants at “nearly 8 years of age”. The QoL scores were no different to full term babies. VLBW infants with major morbidities did however have lower scores in some domains, specifically, “eating, speaking clearly, going to the toilet, learning and concentrating at school and dissatisfaction with the subjects appearance”. As they appropriately state, this means that we need to work harder to avoid those morbidities. Which are: cerebral palsy, visual impairment and “obstructive airways disease”.

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Can we stop worrying about neonatal hypoglycaemia?

Posted on 21 October 2015 by Keith Barrington

In the same, neonatal, issue of the Formerly Prestigious New England Journal of Medicine as my recent post about inhaled steroids, is a fascinating cohort study of serial blood glucose monitoring in 404 at-risk term infants (the CHYLD study). The infants were initially enrolled in two studies, one of them examining the effects of hypoglycemia on the EEG and the other being the “sugar babies” study, an RCT looking at the use of oral glucose gel as treatment for hypoglycemia. About 75% of them had continuous subcutaneous glucose monitoring started at a median of 4 hours of age. The definition of hypoglycemia used for the primary analysis was a glucose less than 2.6 mmol/L (multiply by 18 for old-fashioned folks= 47 mg/dl).

In both of the initial studies, the protocol was designed to monitor the blood glucose at 1 hour of age then before feeds every 3 to 4 hours. In both studies the protocols were designed to intervene and attempt to maintain a blood sugar above 2.6. Babies from both of those other studies were enrolled in a follow-up program which examined them at 2 years of age with Bayley scales (version 3) and tests of executive function.

They defined 2 major outcomes,

Neurosensory impairment was defined as any of the following findings: developmental delay (BSID-III cognitive or language composite score of <85), motor impairment (BSID-III motor composite score of <85), cerebral palsy, hearing impairment (requiring hearing aids), or blindness (≥1.4 logMAR [log10 of the minimal angle of resolution] in both eyes).

Processing difficulty was defined as either a motion coherence threshold or an executive-function score that was more than 1.5 SD from the mean, indicating performance in the worst 7% of the cohort.

The investigators found no evidence of an adverse effect of low blood sugars at 2.6 mmol/L threshold, (nor at lower thresholds, of 2.3, 2.0 or 1.7, at least as far as I can see from the figures provided in the supplementary appendix). When they looked at the data from the continuous subcutaneous monitoring, there was also no convincing evidence of an adverse effect of low blood sugars, even though a quarter of the babies with low blood sugar actually had hypoglycemia that lasted for 5 hours of more when they examined the data from the continuous monitoring (which they call interstitial glucose in the article).

In fact there was some evidence that babies who had an early blood sugar above 3.0 mmol/L actually had worse outcomes.

This makes me feel good, (when I first typed that it came out “this makes me feel god”, I hope that isn’t a Freudian mis-type!) because the statement that the Fetus and Newborn Committee of the CPS came out with, while I was chair, suggested that a first blood glucose of 1.8 (at 2 hours of age) was acceptable (although it needed following). And that eventually blood sugars should be maintained over 2.6. This was based on relatively limited data, which suggested that the lower limit (or rather the 5th percentile) of blood glucose in healthy full-term breast fed infants with no other risk factors was about 1.8 at 2 hours of age. Of course basing a recommendation on a statistical norm in a healthy population, and then applying them to an at-risk population as a goal of therapy is not necessarily correct.

So maybe we haven’t done any harm with those recommendations, at least, and we might have reduced some over-interpretation and over-treatment of a usually benign phenomenon, which looks like it may be benign even in at-risk babies.

But:

The real problem with all this comes from another very recent publication which suggests that transient hypoglycemia might be harmful. Kaiser JR, et al. Association between transient newborn hypoglycemia and fourth-grade achievement test proficiency: A population-based study. JAMA Pediatrics. 2015;169(10):913-21. It is a study with a different design, different analysis, and different conclusions. In this study from a hospital in Arkansas they had a universal glucose screening policy. The first screen was done at 1 to 3 hours of age, and the “usual practice” was to treat if the glucose was <2 mmol/L. In this study they compared school outcomes between children who had 1 blood glucose <2, <2.25 or <2.5. Children whose neonatal blood sugar was still below the particular threshold on the second blood sugar were eliminated.

They started out with nearly 2000 babies (of 23 to 42 weeks gestation) who had blood sugar results, and were able to confidently match about 1400 of them with school achievement scores.

The babies who were hypoglycemic, below each of the thresholds, were more premature, lower birth weight, and more likely to be twins and more likely to be SGA. their mothers were more likely to be diabetic, have pregnancy complications, and a cesarean delivery, they were also more likely to have not completed high school. All of these variables were then put in a logistic regression, which finally showed an association between having a single blood sugar below each of the thresholds and having lower proficiency on the math or literacy tests.

I’m really not sure about these data, the hypoglycemic babies had so many different characteristics than the non-hypoglycemic, that I am uncertain if logistic regression can really correct for all of them.

What to do with all this, I don’t know if we will ever have an RCT to answer the questions surrounding early hypoglycemia in the newborn. The CHYLD study suggests that at-risk babies, if treated in a protocol designed to try and get the blood sugar over 2.6 mmol/L (47 mg/dl) don’t have any adverse effects of blood sugars getting as low as 1.7 mmol/L. The Kaiser et al paper suggests that in a heterogenous and unselected group of newborns, with a usual practice of trying to get the blood sugar above 2, there is an adverse association of having just one blood sugar under 2.5.

My take on this is that we could continue to follow the CPS statement recommendations for now. I think there is too much risk of residual bias in the Kaiser data to change practice and aim for higher blood sugars, but I must say I am not certain about that, and I don’t know how we will even answer the question. We need more data, it is easy to always say. I think more cohort study data as high quality as the CHYLD study might be able to give us clearer answers. Although the sample size of CHYLD was good, more data with larger samples, and including some lower-risk babies would help. I guess I could dare to suggest an RCT? If we randomly compared at-risk babies at one hour after birth, with 2 different thresholds for intervention, and an effective but non-invasive intervention, and followed them for long enough to see a clinically significant effect, then we could get the answers we need. Any takers?

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A couple of excellent articles

Posted on 20 October 2015 by Keith Barrington

The first of these 2 articles is a general tale of evidence-based medicine. One of the best articles (or blog posts) that I have read in a long time, from the excellent David Gorski of Science-based Medicine, who is also known as Orac (whose blog is ‘respectful insolence’). It is a discussion of why campaigns such as choosing wisely may fail unless we put different structures in place to support the initiatives.  www.sciencebasedmedicine.org/choosing-wisely-changing-medical-practice-is-hard/ he discusses, among other important issues, the place and the importance of comparative effectiveness research.

Another article, this time from Mother Jones, not a science publication; the writer shows a better understanding of the science surrounding breast cancer screening than many supposedly science based journals, or “scientific physicians” such as Dr Daniel Kopans from Harvard, a radiologist who can always be counted on to criticize studies which call into question the value of universal mammography.  www.motherjones.com/politics/2015/10/faulty-research-behind-mammograms-breast-cancer

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Outrageous marketing at the CAPHC meeting, selling out for a free lunch.

Posted on 19 October 2015 by Keith Barrington

I was going to write a short post about my presentation at the meeting of the Canadian Association of Pediatric Health Centers (CAPHC) in Quebec city.  I was asked by the organizers to talk about how variations in practice affect patient safety. So I put together what I think was a great panel, with myself, Sophie Gravel, our NICU co-ordinator also a mother of a preterm infant and a breast-feeding advocate, and Barbara Farlow, an active member of Patient Safety Canada and a mother of a girl (who had trisomy 13) who died in hospital at a few weeks of age.

I think the panel went well, we had a good attendance and good comments, and I certainly learned a great deal from my co-presenters. The symposium was sponsored by Mallinckrodt, who are now the company responsible for selling and marketing inhaled NO. Which is not the subject I am referring to in the title of this post. Mallinckrodt had no input into the subject of the symposium, or its content, and I did not mention nitric oxide in my talk (even though use of iNO in the preterm is great example of what I was discussing, variations in practice!) It was, I think a good example of a non-directed educational contribution from a pharmaceutical/medical supplies company. (Even though I still feel uncomfortable accepting my expenses and honorarium from “pharma”. My honorarium will be donated to my research funds).

What stunned and outraged me was what I found in the materials I received when I registered for the meeting.

At noon today there is a talk on using exclusive human milk feeds for preterm infants, sponsored by the only company who supplies human milk-based formula and fortifier for preterm infants.

This is outrageous.

CAPHC should be ashamed.

This breaks all the rules that they should be abiding by,

It is an immoral sell-out.

The organisation, which has a mission “to improve health service delivery for Canadian children and youth”, has sold out so that its members can get a free lunch.

Alan Lucas, whose research has been important in improving care of preterm infants, has been flown in from London to give some sort of credibility for this symposium. Apparently he is going to discuss the proven benefits of an exclusive human milk based diet in preterm infants. Which should take him about 3 minutes.

To recap, for those who have not been memorizing my blog posts for the last few years.

Prolacta, for it is they of whom I speak, have sponsored 2 trials in preterm infants (500 to 1250 g birth weight). One modestly sized study of infants whose mothers were planning to breast feed (n=207), another very small trial for infants whose mothers could not or did not plan to (n=53). The studies were registered as a single trial, but reported as 2 trials (which I think is OK for these trials, there was no real overlap either in the interventions or in the patients) the trial in formula fed babies was blinded, the other was not. The primary outcome for the trials was duration of Parenteral Nutrition: the formula trial showed a reduction in TPN duration, the other did not. The initial study reports show trials that are pretty reasonable quality, apart from the very small size of the formula trial. Unfortunately there have been 3 publications of post-hoc secondary analyses of the trials, as the company try to squeeze more significant data from the results.

Prolacta make a great deal out of the fact that the rate of NEC in the control groups in the 2 studies was very high (21% in the formula trial controls, 16% in the breast fed trial controls, who got cows’ milk based fortifier or cows’ milk based formula if they ran out of mother’s milk).

That isn’t of course how the company promotes their milk. They promote it as showing a significant reduction in NEC. In fact if you do the statistics yourself, the trial that was entitled “An Exclusively Human Milk-Based Diet Is Associated with a Lower Rate of Necrotizing Enterocolitis….” actually shows a difference in NEC (which was a secondary outcome and should not have been in the title) which is only significant if you put the 2 human milk groups together.

As I said, before I got a bit side-tracked, discussing the results of the one (or maybe two) trials should not take Dr Lucas very long.  If Dr Lucas was a Canadian Physician he would in fact be in breach of the CMA guidelines which clearly state the following:

Physicians should not engage in peer selling. Peer selling occurs when a pharmaceutical or medical device manufacturer or service provider engages a physician to conduct a seminar or similar event that focuses on its own products and is designed to enhance the sale of those products. This also applies to third party contracting on behalf of industry. This form of participation would reasonably be seen as being in contravention of the CMA’s Code of Ethics, which prohibits endorsement of a specific product.

CAPHC you should be ashamed. You must also change your practices, we can have no respect for an organization prepared to allow this sort of seminar as part of its meetings.

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Early steroids to prevent Chronic Lung Disease; give them directly into the lungs?

Posted on 16 October 2015 by Keith Barrington

Bassler D, et al. Early Inhaled Budesonide for the Prevention of Bronchopulmonary Dysplasia. New England Journal of Medicine. 2015;373(16):1497-506. One of those ongoing trials that we have been awaiting the results of has just been published. The NEUROSIS trial was a randomized controlled trial with a very respectable sample size, 863 infants less than 28 weeks, by far the largest investigating this issue. Babies got budesonide (or placebo) twice a day by a metered dose inhaler with an aerochamber until they were 14 days of age then once a day until they were 32 weeks or off oxygen.

The results showed a reduction in the primary outcome, (death or oxygen requirement at 36 weeks) with the inhaled steroids. There were no clinical complications that were substantially different between groups. Mortality was numerically higher in the budesonide group, 16.9% compared to 13. 6%, and BPD was much lower, 27.8 vs 38%.

There were similar reductions in the primary outcome in the most immature stratum, as well as in the more mature babies. The 2 components of the primary outcome changed in different directions, as you can see from the numbers above. What I don’t understand is why this difference in mortality is referred to as a ‘borderline significant between-group difference in the rate of death’ the 95% confidence intervals are far from from suggesting a difference between the groups, the relative risk of death, with 95% confidence lies between 0.91 to 1.69.

I think this study was performed to the highest standards, and the presentation of the results is appropriately conservative. Maybe too much emphasis is placed on the no-where-near significant increase in mortality, but the long term clinical significance of oxygen requirement at 36 weeks of age is also quite questionable.

Some animal models show adverse effects of steroids on lung growth, even though the steroids reduce pulmonary inflammation. So a reduction in the proportion of babies needing oxygen at 36 weeks does not necessarily mean that long term pulmonary health will be improved. Indeed the studies of dexamethasone as treatment for BPD, despite a reduction in the diagnosis of BPD (because short-term improvements in gas exchange lead to fewer babies needing oxygen at 36 weeks), do not show any improvement in longer term pulmonary health.

We need to rethink how we do studies such as this, it could be considered a positive study, as the primary outcome was improved, or a null study, because the more important outcome, death, was not different between groups. What we really need now is to know if those babies who got the steroids have better pulmonary health in the first years of life, or not. And also, of course, whether their neurological and cognitive development has been affected.

A systematic review of similar studies with data on mortality may help to clarify if that difference is just a fluke, or part of a wider pattern.

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At least they weren’t worse off.

Posted on 14 October 2015 by Keith Barrington

Fever is a frequent response to infection. The inflammatory response to invading organisms often leads to a febrile reaction, which many have suggested is an adaptive response, that might actually have an evolutionary advantage, and improve survival from serious infections. Of course it is also possible that it is an epiphenomenon, without survival impacts, or that it had a minor effect in the past, but not compared to ICU and antibiotics.

In countries with high resources, death from sepsis is rare, outside of intensive care units. So this study (Young P, et al. Acetaminophen for Fever in Critically Ill Patients with Suspected Infection. The New England journal of medicine. 2015.) recruited the kind of patients where an effect of fever, and any potential adverse effect of using antipyretics, would be evident.

Basically they found nothing.

There was no adverse or beneficial effect of treating fever with acetaminophen (paracetamol for the europeans) on any of the outcomes in this large multi-center trial of 700 critically ill adults in Australian and new Zealand ICUs. Either the primary outcome “ICU-free days” or the secondary outcomes.

Like anything else it might be different in children or newborns, but there wasn’t even the hint of an effect. Which means, I think that we don’t need to worry too much about giving acetaminophen to febrile babies or our own children. If it makes them feel better, then go ahead.

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