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Probiotics in NICU - safe preparation guidelines?


Guest charris

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Guest charris

Hello 99ers,

In Canada, very few hospitals are using probiotics so far.  We started almost 18 months ago, using the protocol from Dr. Keith Barrington's group. The product that we use is called "FloraBaby ®". 

 

At this point, the RNs receive a jar per baby, and on the benchtop where they do regular medication preparation, they place the jar on a paper towel, don sterile gloves, measure out the 0.5 g of powder, and mix it once daily with the baby's feed, then recap the jar & throw out the gloves and paper. That's it.

 

Does anyone have a better idea on how to deal with live organisms? Do any countries who have been using probiotics for many years have a guideline on how these products should be safely dispensed, eg. Japan?

 

  Another hospital in our province will be starting to use probiotics in their nursery shortly, and what I've heard is that they will have pharmacy make up individual doses in a laminar air flow hood in the pharmacy. The tech doing that would presumably  be gowned, masked, gloved etc. full battle gear.

 

Thanks for your thoughts,

Connie Harris, Pharm.D 

neonatal pharmacist,

Victoria, B.C., Canada  

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Probiotics the hot topic did not get the deserved attention.Reason being one standard preparation availability ,paucity of recent data,Standard monitoring  of the organisms etc.Safety of preparing them is definitely a concern as we r dealing with live organisms and exposing  vulnerable preterms to them.

What are the standard preparations available in India.Sinngle org or multiple strains are better.

Planning to start in > 32 weeeks and study the profile before moving over to < 32 weeks.Any suggestion on products pl??

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This comment was posted on our Facebook page (https://www.facebook.com/99nicu)

 

We use probiotics in our unit. Not sure of the brand, but i can find out. I think its chinese. They come in sachets. 1 sachet mixes with 2ml sterile water. The coordinator makes a batch up in a syringe then takes a measure out for each baby then any left is discarded.

 

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We were beginning to use Biogaia ® based on Spanish recommendations: (Nutr Hosp. 2014;30:329-337), but recently, in Miami Neonatology 2014 (the conference), Dr. Josef Neu said that more RCTs were needed; that there were many strains of probiotics and we could not be sure which to use. He also mentioned that they were manufactured as food supplements, thus not as safe to use as FDA approved medication.

We have stopped using them now, but our team will rethink the issue shortly.

It'd be great to hear opinions about this!

 

Patricia Alvarez Cantwell

Attending Neonatologist

Hospital Puerto Montt

Chile

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  • 2 weeks later...
I received warning e mail on 25/11/2014 ,that I want to share with you  Regarding the Fatal gastrointestinal mucormycosis in an infant following use of contaminated ABC Dophilus from Solgar Company‏ 

CDC, FDA, and the Connecticut Departments of Public Health and Consumer Protection, are investigating a fatal case of GI mucormycosis in a premature infant of 29 weeks gestation following the use of a probiotic supplement called ABC Dophilus distributed by Solgar, Inc., Leonia, NJ.

Shortly after birth, the infant received a probiotic supplement called ABC Dophilus, distributed by Solgar Inc., as prophylaxis against necrotizing enterocolitis (NEC). Subsequently, the infant developed signs and symptoms consistent with NEC. Surgical exploration revealed necrotic bowel which was resected. Histopathology results from the resected bowel revealed a heavy fungal burden with angioinvasion, consistent with a Mucormycete infection. 

Sequencing of fungal DNA recovered from the infant’s tissue block identified the fungus as Rhizopus oryzae, a pathogenic Mucormycete. R. oryzae was also recovered from  unopened bottles of Solgar ABC Dophilus, lot #074 024 01R1, the same lot administered to the infant.  Solgar ABC Dophilus is a probiotic product intended to contain Bifidobacterium lactis and Lactobacillus rhamnosus and has been used to prevent NEC in premature infants.  This product is available for purchase in retail stores and online retailers and is used in healthcare settings.

The investigation into this fatal case of GI mucormycosis and its association with the contaminated Solgar ABC Dophilus is ongoing. As such, Solgar ABC Dophilus should not be used, especially in infants and children who may be more susceptible to infection, until further information regarding the safety of this product is available.  Clinicians who learn of:

  1. Confirmed or suspected cases of infants with gastrointestinal mucormycosis (diagnosed via culture or histopathology), OR
  2. Unexplained infant deaths  within 30 days of receipt of Solgar ABC Dophilus

since November 1, 2013 are asked to notify their respective state health departments; state health departments are, in turn, asked to notify CDC Mycotic Diseases Branch,  Dr. Tiffany Walker atydj7@cdc.gov or 404-639-2641. 

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  • 6 months later...

The evidence is piling up in favor of the use of probiotics.

 

Do any of you have a protocol for using probiotics?

My team has researched and reflected on this for a few months now, and we are ready to start using them again, so I was put in charge of the protocol. 

I will be happy to share my " ELBW enteral feeding protocol" plus probiotic use after I am finished, but I need help with the probiotic use part.

 

Thanks,

 

Patricia Alvarez Cantwell

Attending Neonatologist

Hospital Puerto Montt

Chile

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  • 1 month later...

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