In this video, Ms. Chandonnet discusses her research on whether Chlorhexidine Gluconate (CHG) should be used in infants less than 2 months of age.
Hello and welcome to this nursing world shared practice forum my name is kari couch our ski and i am the clinical coordinator in the neonatal intensive care unit at boston children’s hospital today we are pleased to welcome celeste chandon a to discuss her pilot study on the safety of chlorhexidine baths in patients less than two months of age celeste is currently
An infection preventionist at boston children’s hospital she has been a valued member of the bch community for 25 years working in the nicu for most of that time in addition to her extensive clinical background in the nicu celeste has a passion for research and evidence-based practice her commitment to safety and decreasing infections and the vulnerable newborn
Population led her to become the principal investigator on the first nurse led fda-regulated study at boston children’s hospital on the safety of chlorhexidine bathing in patients less than two months of age welcome celeste thank you for having me given that healthcare associated infections are a significant contributor to both morbidity and mortality and neonates
And children are particularly vulnerable to these i’d like to begin by asking you to tell us more about your research and what encouraged you to study chg the question of using core hexamine bath for clabsi reduction surfaced in 2013 during safety and steering committee meeting in the nicu i was the unit based infection prevention nurse at the time we were having
An increase in central line bloodstream infections and so i started the discussion about possibly incorporating core hexamine bathing for clabsi prevention in the nicu and that discussion stimulated many questions about the safety profile of chlorhexidine in the nicu setting so after doing an evidence-based literature search we revealed that there is definitely
Overwhelming evidence that supports chlorhexidine bathing as a clabsi reduction in pediatric and adult populations but there was a lack of research with premature infants neonates and even patients up to one year of life so we did find evidence in the literature of you know anaphylaxis skin reactions and even some burns and patients that were exposed to chlorhexidine
But there really was insufficient evidence on its safety so once we had a chance to review this information we decided that we needed more information before we could implement this practice in our nicu so we convened a research team to develop the research protocol and proceed with studying the safety of this potential treatment we decided that we would begin with
Near-term infants and those less than two months of age for our first step celeste why is the patient population that you were studying more at risk to side effects of chg there are a number of risk factors that need to be considered when working with newborns including the chlorhexidine skin absorption excretion and the overall lack of research to guide providers
In the safe and what a safe chd level is so for skin absorption chlorhexidine with young infants requires a special consideration such as the thickness of their skin so only units have a degree of epidermal barrier maturity although the basal epidermal barrier is competent immunity after birth the stratum corneum isn’t contributing to less barrier protection and
More epidermal permeability and this is increased in prematurity so these physiologic characteristics of newborn skin lead to risk of body water loss systemic infection from invading microorganisms and not surprisingly percutaneous drug or chemical absorption and while it’s believed that chlorhexidine is cleared by the liver the method of which chlorhexidine is
Excreted from the body is not well understood there have also been few studies where chlorhexidine levels were monitored and the lack of this research is most likely related to or influenced by the us food and drug administration had labeling on chlorhexidine that said do not use on patients less than 2 months of age and in 2012 they changed that labeling to use
With caution in infants under 2 months of age and since that revised labeling there is an tadaryl and published reports that have suggested an increased use the purpose of this study is to investigate the safety of bi-weekly chlorhexidine baths in a sample of newborns 36 to 48 weeks post menstrual age with the central venous catheter we would like to now turn to
Our audience and ask a question when you reply please leave your city and country location the question is do you have an age cutoff for the use of ch g if so does it depend on how it is being applied and now we’re back to our discussion with celeste celeste you mentioned the journey starting in 2013 when did you realize this was going to require the guidance of
The fda after we presented our first protocol to the irb we found out that we needed to get an investigational new drug exemption so that we could use the chlorhexidine class for our off-label purpose chlorhexidine bath cloths are marketed for preoperative bathing and even though we are aware of the widespread use of chlorhexidine bathing cloths for daily bathing
We needed to get approval from the fda in order to use it for our study population so the fda rejected our application for an ind exemption so we had to go for a full ind and that whole process took a little over a year that sounds like a long process can you share a little more detail about the process of submitting to the fda yes it was a long process it was
A very detailed process the actual ind itself was over 700 pages and required multiple expertise throughout the hospital to participate in it but we did eventually get awarded the ind and continued to communicate with the fda and the irb for another year before we were ready to start enrolling subjects so although the process was very long through it all the
Fda was very supportive and just wonderful to work with there was a cohesiveness between us and them because we were all invested in establishing a protocol where patient safety was a top priority so now let’s transition a bit and focus on the study itself can you describe the study design and methods sure the study was a prospective experimental descriptive
Pilot study which was consistent with the phase 1 clinical trial our subjects received twice weekly baths on mondays and thursdays between 8 and 10 a.m. which was consistent with the time frame on fridays where we got the chlorhexidine levels the chd baths were performed by trained study personnel which involved ensured a standing bathing technique was followed
And we also added booties to the heels to protect possible sample contamination which was cited in the literature so our two primary research questions where the first one was our twice-weekly chlorhexidine bath safe for use in a sample of infants greater than 36 weeks pma in less than 2 months of age and does twice weekly chlorhexidine baths lead to rising or
Cumulative chlorhexidine blood levels over time in a sample of infant’s greater than 36 weeks pma and less than 2 months of age so we conducted this study in our 24 bed level four nicu and thirty-one bed pediatric cardiac intensive care unit both serviced tertiary care referral centers for critically ill infants we included infants greater than 3 days of life
Between the ages of 36 and 48 weeks post menstrual age which we defined as gestational age plus chronological age inclusion criteria included patients with the central venous catheter or soon to be placed central venous catheter permission to participate by their attending physician and then parental consent we found evidence in the literature that supports
Increased chlorhexidine absorption when mucous membranes are exposed to it so we excluded infants with skin issues like egg theosis or an unrepaired gastroschisis most drugs or chemicals are excreted through the renal or hepatic system so we excluded infants that had evidence of renal or liver compromise as identified by an abnormal creatinine ast or alt we
Also excluded infants with low hematocrit because we didn’t want the required study lab work to further potentiate iatrogenic anemia infants with hepatic ischemic encephalopathy or deemed clinically unstable by their attendings were also excluded so to answer our first research question about safety of chlorhexidine bass in a sample of infants 36 to 48 weeks
Post menstrual age we monitored subjects for potential skin reactions to chlorhexidine so every subject had a head to toe skin assessment prior to study initiation immediately before any chlorhexidine bath and then every 12 hours for the duration of study participation we also monitored weekly chlorhexidine levels serum creatinine ast alt and am adequate at
Baseline and then every friday between 8 and 10 a.m. so we have frequently assessed these labs for any correlation with chg to ensure the safety of our subjects to answer our second question of accumulation of chlorhexidine blood levels over time we obtained weekly chlorhexidine gluconate levels to see if they were trending upwards however because there is no
Evidence on what a safe chlorhexidine level is we did not use this information to guide clinical decisions during study participation we would like to turn now to our audience and ask another question when you reply please leave your city and country location the question is this do you routinely utilize chg for prevention of healthcare-associated infections in
Patients less than two months of age or new unit and do you have a policy or guideline to support this practice now let’s turn our focus back to our conversation with celeste given the vulnerability of this patient population it sounds like there are a lot of very important details to consider absolutely so how many subjects did you enroll and what did you find
While our intended sample size was 50 subjects with a plan to conduct an interim analysis after every 10 subjects and present the findings to the data safety monitoring committee however our first interim analysis coincided with our first annual fda review and at that point both our study team and the fda had concerns related to elevated chlorhexidine levels
From our study subjects so out of an abundance of caution and because of the lack of information on the safe chlorhexidine level and with the recommendation of the fda the study was closed with a plan to move forward with dissemination of our findings so in the end we ended up with a total of 10 subjects enrolled in nine subjects that had study interventions
Done for analysis none of the subjects had untoward skin reactions related to the chlorhexidine bathing although we did have two subjects that had minor skin rashes that were evaluated and deemed not related to the cortex nia bass because they were in areas that weren’t bathed during the study process so a total of 89 core heading exposures were analyzed there
Was no evidence of accumulation of chlorhexidine although there was evidence of higher absorption in this population when compared to chlorhexidine levels found elsewhere in the literature so our levels range from non-detectable to 3206 so renal and liver function tests were stable on all of our subjects even those with the highest levels there was no evidence
Of correlation between the chlorhexidine levels in gestational age the chlorhexidine levels in weight at time of enrollment or the chlorhexidine levels in week number of weekly chlorhexidine exposures celeste 89 exposure sounds like a lot for nine infants enrolled can you expand on what those exposures were the 89 exposures were all chlorhexidine exposures
That a study subjects were exposed to not just the study baths so we monitored if a patient study subject was exposed to chloride sene for skin antisepsis for a central line dressing change or if they had a preoperative chlorhexidine bath for cardiac surgery so all of those 89 exposures are not reflective of just the chlorhexidine pass for the study we would
Like to ask a final question of our audience when you leave your reply please leave your city and country location the question is does the information we’ve provided related to chg absorption in patients 36 weeks to 48 weeks gestation compel you to reevaluate your current practices related to the use of chg in your units and now we’re back with celeste as an
Infection preventionist and leader in infection control how do you interpret these results and what do you recommend to other leaders considering the use of chg on patients less than two months of age we understand the sample size is a limiting factor and providing definitive recommendations however we still feel the study adds to the body of knowledge on the
Safety of chlorhexidine use and we feel an obligation to share this with providers caring for this fragile population and there remains a lack of guidance as to what would be considered a safe level of chlorhexidine in the blood so it’s our hope that clinical providers who care for new units will weigh both the benefits and the risks when considering the use of
Chlorhexidine bass and other chlorhexidine containing products with infants less than two months of age celeste your commitment to this research project is really commendable not only was infection prevention at the forefront of your research in addition patient safety was also a major factor in your study can you tell me a little bit more about your project team
Yes this research study was quite an undertaking and required multidisciplinary team support across the hospital we had many members within the neonatal intensive care unit and the cardiac intensive care unit that contributed as well as pharmacy the laboratory medicine and then we were able to get grant support from the american association of critical care
Nurses as well as newborn medicine and laboratory clinical fellowship program and the program for patient safety and quality at the hospital so all of that was really essential in having this be a success celeste have the findings in your study influenced the care at boston children’s hospital i believe they have i know that our nicu has not instituted daily
Bathing of cora hexina patients with a central line that are under 2 months of age and i know that we get a lot of questions about what our practice is from clinicians around the country are you planning on disseminating this these findings in this research i’m glad you asked that yes we are finishing up the final touches on our manuscript and hope to submit
That soon and we presented our findings at a national teaching institute conference in may of this past year and also to a consortium of pediatric cardiology clinicians celeste thank you so much for sharing your work today healthcare providers across the globe treating this very vulnerable patient population are constantly looking at ways to prevent infection
So thank you for asking that question on is chg safe in this patient population thank you carrie you
Transcribed from video
"Chlorhexidine Usage in the Infant Population: Is It Safe?" by Celeste Chandonnet for OPENPediatrics By OPENPediatrics
