Probiotics to Prevent NEC: Why aren’t we saving babies yet?

Posted on 5 May 2012 by Keith Barrington

The latest systematic review of Probiotics to Prevent NEC in Preterm infants Wang Q, Dong J, Zhu Y: Probiotic supplement reduces risk of necrotizing enterocolitis and mortality in preterm very low-birth-weight infants: an updated meta-analysis of 20 randomized, controlled trials. J Pediatr Surg 2012, 47(1):241-248. http://www.sciencedirect.com/science/article/pii/S0022346811008360

With the addition of 4 studies in the Chinese literature this review which now includes over 4000 babies confirms a reduction in NEC, by 67%, and a reduction in mortality of 44%. Unfortunately there was no further data regarding mortality added by the Chinese trials.

At the recent Pediatric Academic Societies meeting in Boston 2012, the results of another trial were presented (Rojas M and Lozano J). Mario Rojas and the Columbian Neonatal research Collaborative have done a number of very nice trials; this one in relatively low risk babies, showed less NEC and fewer deaths. Their primary outcome was mortality and nosocomial infection, which was not statistically significantly affected by probiotics.

Just as I was about to ‘go live’ with this blog, yet another trial has been published, this small trial had 75 infants per group of less than 1500 g birth weight. They had fewer cases of NEC and fewer deaths with a probiotic mixture compared to the controls.

Fernández-Carrocera LA, Solis-Herrera A, Cabanillas-Ayón M, Gallardo-Sarmiento RB, García-Pérez CS, Montaño-Rodríguez R, Echániz-Aviles MOL: Double-blind, randomised clinical assay to evaluate the efficacy of probiotics in preterm newborns weighing less than 1500 g in the prevention of necrotising enterocolitis. Archives of Disease in Childhood – Fetal and Neonatal Edition 2012. http://fn.bmj.com/content/early/2012/05/03/archdischild-2011-300435.full

So I just did an update of the meta-analysis, taking out Paolo Manzoni’s important Lactoferrin trial, as there were 3 groups and it’s too complicated to think about what to do with those data when I am on call. I also took out the Costalos study as it was a Saccharomyces, that is a probiotic fungus, and clearly different to the other studies. As you can see the RR for NEC is 0.41 with very tight confidence intervals. Similarly there is a reduction in death of 42%, with a 95% confidence of the true reduction in death being between 56% and 25%.

There are no reported adverse events in any of the studies.

What more will it take to make this routine therapy in at-risk infants?

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Can we study Hypotension in Extremely Preterm Infants?

Posted on 5 May 2012 by Keith Barrington

Dr Beau Batton and colleagues from the NICHD network have just published a paper detailing their attempt, and failure, to design a trial of early hypotension treatment. The design looks fine on paper, but when they tried to do the trial there were numerous road blocks. One arm of the trial included hydrocortisone, so babies receiving prophylactic indomethacin were excluded, which was a practice that changed after design of the study.  There were fewer hypotensive babies than expected. But even of the eligible babies, only 17% were enrolled.

Establishing equipoise will be a major problem in doing trials, but it is very important that we answer the questions about how to treat hypotension in extremely preterm infants.

The link on the side bar to the HIP trial will take you to the website for our trial, which will be starting soon, which will try and answer the question ‘among infants less than 28 weeks gestation who have a low blood pressure and good clinical perfusion in the first 3 days of life, does treatment with dopamine compared to placebo improve the chances of surviving to 36 weeks without a serious brain injury?’

Batton BJ, Li L, Newman NS, Das A, Watterberg KL, Yoder BA, Faix RG, Laughon MM, Van Meurs KP, Carlo WA et al: Feasibility Study of Early Blood Pressure Management in Extremely Preterm Infants. J Pediatr 2012(epub before print).http://www.sciencedirect.com/science/article/pii/S0022347612000339

Vain NE, Barrington KJ: Feasibility of Evaluating Treatment of Early Hypotension in Extremely Low Birth Weight Infants. J Pediatr 2012(epub before print).http://www.sciencedirect.com/science/article/pii/S0022347612002326

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Hello Newborn World!

Posted on 5 May 2012 by Keith Barrington

For many years I have been screening a number of websites, contents pages of pediatrics and general journals, and other services to add references to my personal database, and also to send out reading lists to fellows, nurse practitioners and others who might be interested (or not).

So why not make it into a blog, thought I.

Here it is, please let me know if you find it helpful.

Posted in Neonatal Research | 2 Comments