Nicholas Embleton

Hi Nestor, I agree; the trial was inadequate, the 'expert witness' is not credible (not an experienced NICU consultant) and I agree the experts on Shoo's panel are experienced. But, they made some comments that I need to know more about - I don't know the cases - but I do not believe you can say all these cases are "natural" and the deaths are due to poor medical management. Of course, many of the deaths might be 'natural' = 'bad luck' but surely that does not easily explain all cases. There were comments that "you should never use a size 2.0 ETT" - I have used very successfully in difficult cases to stabilise a baby ; Comments that 96% leak means there is not effective ventilation - that is too simple an explanation. Has anyone else ventilated a baby with a large leak successfully? Yes. Of course we want low leak, but just because the expired gas passes out around the tube does not automatically mean you are not ventilating the baby. From what I heard (and there may be more) the conclusions seem too 'black and white' to say "there are no murders". Pro bono is great - but we are all far more bothered by our reputation than money! But pro bono does not equal "no conflict". And confirmation bias works both ways - maybe they started out believing she was probably innocent and then reviewed. I agree - we don't know the truth and we need a review ; but the reporting of the panel conclusions is not clear We need a debate!

This case is hugely concerning, but we do not know the facts. All of us who take part in mortality review meetings know that we can not always explain every death; we sometimes disagree on the primary cause. We all have examples of cases where we thought one cause, but PM revealed another. What is written in the notes, or recorded, does not present the full picture. Sometimes there are 'gaps' because we were too busy to write, or forgot. I listened with interest to the presentation from Shoo Lee; the panel seem 'clear' they have an alternate explanation (other than deliberate harm) for every case. That is quite a brave claim. I do not know the make-up of the panel members, but I would also make the point that neonatologists with strong academic credentials are not necessarily any 'better' at determining clinical management, and working out what might have happened i.e. the sequence, than 'jobbing' neonatologists. If my own baby needed resuscitating I would rather have a neonatologist with zero publications who had intubated 400 babies in the last 10 years, rather than published 400 papers but resuscitated none! I am not saying they are wrong or right; or that Letby is likely innocent or guilty. I don't know, and opinions are cheap. It is clear the 'system' has failed on multiple levels and we need a full enquiry. To fully review a single death on a NICU takes around 2 hours and requires 4-6 (or more) experienced neonatologists; also nurses, pathologists, obstetrics; ideally with at least 1-2 external (non-conflicted) neonatologists. How much time do you all have in your job plans to undertake this activity? Also note, this unit typically had 2 deaths per year until 2015 and 2016 where the annualised rate is closer to 8 - the probability of that happening by chance is less than 1%. Of course if you take 100 neonatal units, then a 1% chance happens to one unit every year (on average). But who in this audience would have watched 8 deaths a year and said "...oh that is bad luck" or "...we used to be very good, why are we now so bad?" [Stefan - can you add me a legal disclaimer !!]

Thanks Kaltirkawi - I agree, I have never been convinced that adding MCT oil to promote growth (as opposed to weight gain) is truly beneficial. I am sure it increases weight gain - there are extra calories and CO2 production is less than glucose; but I would be concerned that the 'weight gain' is primarily fat. Most preterm infants with slow growth are probably getting insufficient protein - very likely to be true if using donor milk, but probably also true with MOM. So adding MCT might appear to improve 'growth' but it might 'hide' the underlying issue. Without access to a pure protein fortifier that allows you to adjust the intake, it is a complex problem. Blood urea is typically low in these babies but variability means the predictive value (for protein intake) of Urea is poor - however if i observed 'slow growth' with a urea of <3mmol/L AND the baby was on fortified 180-200ml/kg I might add extra protein, or if no protein supplement, cautiously increase the amount of fortifier. In Arslanoglu trials this approach improved head growth. Arslanoglu S, Moro GE, Ziegler EE. Adjustable fortification of human milk fed to preterm infants: does it make a difference? J Perinatol. 2006 Oct;26(10):614-21. doi: 10.1038/sj.jp.7211571. Epub 2006 Aug 3. PMID: 16885989.

Everyone has an opinion, and all of these are valid. For me a few random comments - A definitive trial powered on NEC requires n>3,000 and may never be performed; so in 10 years time we will still now know for certain. What will happen is that NICUs that use, will publish cohort studies, and slowly we will get an idea of which combinations appear most effective. The WHO are funding a trial in LMICs which might (or not) provide information for high income settings. But a negative result might simply reflect the context (biomes, risks and benefits are different in Africa v Asia v Europe) - so we might still not know In 2033, another 10 years of observational studies will further prove the safety of probiotics ( 1 death per 10,000s exposed is very low rate). Invasive sepsis is not related to QC/QA (contamination is) - so you can't decrease the risk of invasive sepsis by manufacturing a "better" product. However, the MCT oil in the FDA case is interesting - did the MCFA provide a direct conduit for the Bifido bacteria to enter the blood stream? There are major risks of commercial involvement - investment of $millions to develop and test a product mean they will use very heavy handed legal powers to shut down smaller manufacturers. Beware! The way forward is via parent/public pressure and advocacy. Parents can look at a Cochrane plot and can easily understand the debate - it is not that complex! You don't need to start probiotics day 1-2 it is OK to wait whilst parents consider the options and have a slightly better understanding of NICU. Parents can request their baby is treated in the same way they can request/decline donor milk. In a litigious medico-legal environment (USA) parents could be offered the information and sign an agreement to say they want their baby treated. I have little sympathy for the FDA - their statement will increase deaths. However, I have some sympathy with the AAP statement. I don't agree with it, but it is very difficult for an organisation like the AAP in a US legal environment to be so definitive. As clinicians, we need to stick together. We all want the same thing. None of us is making money out of the debate! So please keep opinions "tempered" - it is through disagreement and respectful discussion that we will improve care. have a nice day! Nick

We use electronic software (Badger) that calculates growth curves using WHO/UK dataset. More importantly than the specific growth chart used is how you interpret and what you do! Of course all growth charts differ based on reference populations and none are a true standard. Growth rates in g/kg/d vary between 24-40 weeks so charting is always best. But ... what to do if growth is slow? Is there any evidence that increasing weight gain is beneficial for an individual infant? Growth is a measure or a marker of nutritional status, not an outcome in itself. Useful for audit and research, but perhaps less useful on it's own for clinical management. Growth is one element of Nutritional status. Aim of nutrition and feeding is to improve Nutritional Status not to achieve weight gain per se. Embleton_ADC_15mins_NutrAssessment_May2021.pdfEmbleton_ADC_15mins_NutrAssessment_May2021.pdfEmbleton_ADC_15mins_NutrAssessment_May2021.pdfDOI: 10.1136/archdischild-2020-320928