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Surfactant plus Budesonide? Not a PLUSS for outcomes
Many of us were already aware of the general direction of the results of this trial, a multi-centre RCT of surfactant with or without budesonide (Manley BJ, et al. Intratracheal Budesonide Mixed With Surfactant for Extremely Preterm Infants. JAMA. 2024), disappointingly negative results, with no impact on survival or on any index of lung injury. In order to put this in context, I have just been…
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What Sick Babies Can Teach Us
As usual for a TED talk this is 18 minutes long, and, in that brief time, Annie recounts her trajectory: learning from families of kids with trisomy 13 and trisomy 18; our own experience with counselling for threatened extreme preterm birth, from both sides of the conversation; and the Parents Voices Project. The only thing I don’t like about this video is the still that was chosen by their…
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Surgery for NEC; enterostomy or anastomosis?
There are only a few randomized trials in neonatal surgery, but those that exist have had a major impact. This new publication may do the same, even though the sample size is relatively modest, and there are some issues with the article. You can see some of the difficulties in doing such trials from the fact that it took 12 hospitals 9 years to recruit 80 patients, 58 of which came from only 3 of…
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The nicuverse and 99NICU
As some of you may have noticed, I left Twitter (X), apart from sending a link to each new post on this blog. I never any longer visit the website and I have deleted the App on my phone. A great alternative is the nicuverse, nicuverse.org a Mastodon community with many similar functionalities that we could use to chat with each other, discuss research and clinical approaches. You will see also…
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Making Clinical Research Oversight Fit-for-Purpose
The title is a slightly edited copy of the title a discussion article in JAMA, that discusses some important issues in IRB oversight of clinical research. (Kass NE, et al. Making the Ethical Oversight of All Clinical Trials Fit for Purpose. JAMA. 2024), and is part of a special issue including a renewed version of the Declaration of Helsinki World Medical Association Declaration of Helsinki:…
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Badly performed, badly presented, unethical published research; what to do?
Since at least 2013 the World Medical Association Declaration of Helsinki has mandated registration of clinical trials prior to enrolment of the first subject. Since 2005 the International Committee of Medical Journal Editors has required trial registration as a condition of publication, before the onset of patient enrolment. This principle is reiterated in the new version of the declaration of…
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Too much antibiotics, part 2
The multicentre project, that I started the last post with, has just published a new important article, which addresses the duration of antibiotic treatment (Dimopoulou V, et al. Antibiotic exposure for culture-negative early-onset sepsis in late-preterm and term newborns: an international study. Pediatr Res. 2024) and is particularly focused on those babies with negative blood and/or CSF…
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Too much antibiotics, part 1.
An important multi-centre observational study examines how many newborn infants, term or late-preterm are receiving antibiotics, for how long, and the responses to negative cultures. Centres from Europe, Australia and North America are represented. Data collection differs between the participants which are all regional networks (or in the case of Norway, national), but all provided data on babies…
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Does preterm formula cause NEC?
The question in the title was recently adjudicated in US courtrooms, with an enormous award of damages to the family of a premature infant who developed Necrotising Enterocolitis, and survived, but has, apparently, major neurodevelopmental issues. In July, the jury awarded the infant’s mother $95 million in compensatory damages and another $400 million in punitive damages against Abbott who…
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Long-term outcomes after preterm birth; the next step
I usually try to avoid buzz-words and phrases like “paradigm shift” but it applies well, I think, to what is happening in the world of neonatal follow-up, and more broadly, I hope, to neonatal research as a whole. Neonatologists were pioneers in the development of outcome research (Barrington KJ, Saigal S. Long-term caring for neonates. Paediatr Child Health. 2006;11(5):265-6), when we started…
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What should saturation targets be in established chronic lung disease with pulmonary hypertension?
This question has been puzzling me recently, as we are trying to evaluate our current approach, and whether it needs to be changed. My bias has been that oxygen is toxic, and we should only give the minimum needed to maintain adequate saturation. But that, of course, begs the question “what is adequate saturation”? I take my approach partly from the results of BOOST, this was the trial with…
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Making decisions for extreme preterms, do parents regret their choices?
In 2022 we published an article addressing the question in the title. As part of the Parents’ Voices Project, we questioned families of very preterm infants at follow up about their experiences prior to, during, and after the NICU. 98% of families attending responded, the extremely high response rate being partly because they were given multiple different potential ways of participating (on-line,…
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Improving human milk for preterm infants.
Mother’s own milk (MoM) is clearly preferable for the enteral nutrition of all infants, with major advantages demonstrated among the preterm. Despite one bizarre, flawed, and seriously biased article, that I have criticized on this blog, the next best substrate is, also very clearly, donor human milk (DHM). Most DHM around the world is provided by altruistic volunteers who provide milk to their…
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Sending home preterm babies with Inguinal Hernias
It has been dogma for quite some time that newborn preterm infants with Inguinal Hernias (I will resist the temptation to latinise the plural, although I was brought up hearing about ‘herniae’) should have them surgically fixed prior to discharge home because the risks of incarceration were so much higher in the young infant. This practice has been widely followed wherever I have worked;…
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Colostrum and feeding preterm babies
Forgive me if you are already convinced, but I remain somewhat sceptical of the benefits of routinely painting the inside of the preterm infant’s mouth with colostrum. Even though I have supported the introduction of the practice on our NICU, it seems to me to be a bit flaky, to use the scientific term. Can this intervention really have the enormous benefits for the outcomes of our babies that…
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Nosocomial infections, "Hospital-Acquired Infections", and now "Hospital-Onset Bacteremia"
It has been clear for a while that the focus of some groups and some publications on only infections associated with central venous catheters, so-called CLABSI, was missing the point. You could completely eliminate CLABSI by not using central lines, but the babies don’t care what the source of their infection is! Also, most serious infections are Gram-negatives, which are largely the result of…
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Early Exclusive Enteral Nutrition: not Early, not Exclusive, some Parenteral, but interesting anyway.
This could have been part 3 of my recent duet of posts on the potential toxicity of TPN. Those 2 posts referred to the late preterm and the full term newborn. In this study (Razzaghy J, et al. Early and exclusive enteral nutrition in infants born very preterm. Arch Dis Child Fetal Neonatal Ed. 2023) .infants of 28 to <33 weeks GA, who were <36 hours of age were enrolled. It is not clear in the…
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