A Duke visit update...finally!

So much for "I'm still here!"  I had intended to then pick up where I left off and keep the posts coming.  Life kept giving me more pressing issues to contend with including getting both of my children settled in new schools, our family accumulated to a new community and my desire to start addressing the "to do" list associated with a new house.  I'm quickly realizing that the list never ends and only gets added to.  Now, it's also the start of the summer gardening season, and I have a blank slate that needs to be shaped into a thriving garden.  So, if I'm going to keep posting, I have to just figure out where to carve some time and sit down and do it!

Having not updated anyone regarding our last visit to Duke (in January), that's the obvious place to start.  Unfortunately, the trip didn't provide a ton of writing material.  We drove almost 3 hours there, stayed for 30 minutes and then made the long trip home.  Abigail had to sit through a blood draw, but like other visits, she was a real trooper and did so without complaint.  Time has equaled experience and knowledge and study protocols have been amended including the amount of blood drawn.  The nurse took just 2 vials versus the 6 to 7 of previous visits.  They've also amended the frequency of skin prick tests to just once a year.  Abigail's last skin prick test was 6 months ago, so she was off the hook at this visit. The rest of the appointment was spent discussing the upcoming trial move to Chapel Hill and the food challenge marking the conclusion of our 3 year participation in the clinical trial.

At the time of our visit, they had already had 3 other children complete that challenge and consume the full amount of 5 grams of peanut flour, the equivalent of 16 to 17 peanuts. The kids had also eaten actual peanuts in the hospital setting just to make sure they could safely be dismissed to go home and eat more.  I'm getting excited all over again just sitting here typing.  Abigail breezed through her first challenge eating all 2.5 grams without incident.  Since then her IgE number has steadily declined.  I'm very hopeful that she will complete this final challenge as easily as she did the first.

Abigail will most likely do her food challenge in July, and this time we'll be driving to Chapel Hill.  The staff is currently wrapping up the move from Duke University Hospital to UNC.  Like the last challenge, it will be double-blinded.  She'll have to do two.  One with an oat flour and another with the peanut flour.  We won't know which one will be first.  Only the lab tech who mixes the flour in the food of choice, most often applesauce, will know.  I say that, but it won't take long to figure it out.  It's pretty hard to disguise the smell and taste of the peanut and Abigail will pick up on it fairly quickly.  If Abigail digests the full amount plus the real peanuts we'll joyously leave and take a month off from the drops and all peanut products.  We'll then go back a month later and do the food challenge again.  If at that time, she again passes with flying colors, we are free to go home and bring peanut products back into our house.  She'll be under no restrictions as to how much peanut products she can eat, but it's advised that she consume at least 1 1/2  to 2 peanuts daily in some form or fashion.  It's also advised that we continue to carry her Epi Pen.

There's more to write about the visit than I thought, and I'm not done.  I'm going to have to stop though and write a Part 2.  If I'm going to keep up with my posting, then I've got to make these short.  Right now, it's breakfast time and duty calls.  There have been changes made to the study protocol since our visit that I also want to cover.  I'll address those next time.

Thanks for everyone's continued support!  I hope I don't sound to blasse regarding the completion of the trial.  It's been three long years, and frankly, the entire family is ready to get on with our lives.  At the same time, we do realize how incredibly blessed we are to have this opportunity.  "Just a few more months" is quite frequently uttered around our house.  How incredibly exciting!!

Changes at Duke

I must admit, I'm anxious. Dr. Burks has accepted the position of Chair of UNC Department of Pediatrics, Physician-in-Chief of N.C. Children's Hospital and is leaving Duke University Hospital.

We received an e-mail from our doctor in charge of the Peanut Sublingual Clinical Trial assuring us that, for the time being, it was business as usual. We can expect to see changes. The trials are to move to UNC sometime next spring. So, yes, I'm anxious.

Abigail's next appointment is in January for blood work. I assume we'll drive to Durham. Her big food challenge to see if she can tolerate up to 15 peanuts is scheduled for June. That should take place in Chapel Hill. I don't mind the change in location, I just want re-assurance that there are no changes planned for the studies.

Here is the article announcing his new position.

It's Been Another 6 Months

I can't believe it's already been 6 months since Abigail's last appointment for the Peanut Sublingual Immunotherapy Clinical Trial. It was time for another trip to Durham, NC, and the Duke University Hospital. This particular visit marks our two year anniversary in the program. Just 365 more days of daily drops, one more 6 month blood work appointment, two more food challenges and we're done. Unofficially anyway. There will still be follow-up visits to monitor her desensitization.

Another visit down!

You can tell from this picture that Abigail is just thrilled to be back. Upon our arrival, we were just a little confused. "Clinical Trial Research Unit" was no longer labeled on the front doors. At first we wondered, if in the last six months, they had moved the unit to a different part of the hospital. This small sign was all there was to announce that yes we were still in the right spot. They now share this hall with another cancer unit and it got top billing on the big double entrance doors.

This visit, like the rest, started with weight/height measurements and the application of numbing cream on both her arms. She then had to spit in a tube (her least favorite part of the visit) and sit through a skin prick test.  This test is no longer as uncomfortable as it used to be.  The skin reactions are now minimal, and her back doesn't itch near as much.

Abigail's doctor marking where the skin will be pricked.

Final results.  Some swelling at highest dosage (on top left).
Minimal swelling at the remaining pricks.

Here is a link to pictures of Abigail's last two skin prick tests.  There have been visable changes each time.  She also had 6 vials of blood drawn and then it was time to say good-bye to Dr. Kim.  His Fellowship at Duke is over, and he has accepted a permanent job in Chapel Hill.  We'll miss seeing him on our visits.  He was fabulous with Abigail and extremely patient in answering all of my many questions.  There is already another doctor assigned to continue Phase I of the Peanut Immunotherapy Sublingual Trial.  We did not get to meet her at our appointment.  While we were having our visit, she was busy doing a food challenge with the very first patient in Phase II of this trial.  I'll follow up on details of that trial in a different post.

So, what's next?  Daily drops, a report on Abigail's IgE results from this visit and a 6 month lab appointment in January 2012.  Starting in December of this year, the first participants in our trial will be starting their end of study food challenges.  When we go back to Duke in January, we'll be updated on those results.  Then in June, Abigail will have her food challenge.  If she can tolerate it, she'll be given the equivalent of 20 peanuts.  Assuming there are no issues, and I'm not expecting any (she tolerated the full 10 peanuts at her food trial last year), we'll be asked to not give her the drops or any peanut product.  After 6 weeks, she'll be given a food challenge again to see if she can continue to tolerate the 20 peanuts.  If so, we'll then introduce small amounts of peanut into her diet and/or continue the drops.  That's yet to be determined.  And, just as important, if she tests negative again to tree nuts, I'll be able to again purchase products manufactured in facilities using tree nuts.  Even better, her doctor felt she'd be able to pick up a can of any type of tree nuts and just munch.

While a year seems so far away for Abigail, I look back at how quickly the last 2 years have flown by, and how much progress she's made.  I'm looking forward to the conclusion of the study.  What will I blog about then?

Latest Trip to Duke

It's been three months since our last trip to Duke University Hospital.  It was time to hit the road and make the drive to Durham to visit the Duke Clinical Research Unit.

It was a lab visit.  These occur every 6 months.  I think Abigail dreads the saliva collection more than the blood draw.  She dislikes spitting into that collection tube.  She also had another skin prick test.  The last one was done at Abigail's food challenge back in June of last year.  Here's a picture from that test.

 

Here's a picture of her back after the test this week.  The top prick on the left is the highest dose of the peanut protein.  The prick on the bottom right is the histamine.  That first prick is about the same size as the one in June 2010.  The second prick was about the size of a pin head.  Her doctor traced it, but didn't record the others.  There was nothing to trace.  You can definitely see the difference between these tests.  How exciting! 

Last, but not least, they had to do a blood draw to get new IgE numbers.  I know they do a regular blood panel to monitor her overall health, but I'm not sure what else they look at.  Regardless, there were 5, maybe 6 tubes they needed to fill.  Do you know what Abigail did?  The nurse inserted the needle, but Abigail put on and removed each of the tubes.  It was unbelievable.  Here's a picture of her changing out the tube.

Six months ago, Abigail's IgE number was 12.8.  The doctor thinks that this time around we might possibly see a single digit number on the lab report.  I can't wait to get those results!

There was also opportunity to ask lots of questions about what's next for us in the trial as well as get an update on the results to date of the sublingual immunotherapy study. I'll cover all of that in my next post.

Interview with Dr. Wesley Burks

In all of our trips to the Duke Clinical Research Unit, we've never actually met or even seen Dr. Wesley Burks (Chief of the Division of Pediatric Allergy and Immunology at Duke University Medical Center in Durham, NC). This picture is as close as we've come. I've joked before that I feel like if we do, we should ask for his autograph given the amount of publicity he and his department get regarding their research of food allergies.  All joking aside, we are very grateful to Dr Burks and his staff at Duke for allowing Abigail the opportunity to participate in the peanut sublingual immunotherapy trial, and for giving her the chance to become peanut allergy free!

A fellow mom/blogger of food allergic children recently had the opportunity to interview Dr. Burks.  She has an informative website, www.allergymoms.com and a blog at http://www.allergymoms.com/modules/wordpress/index.php.  Here is the link to her interview with Dr. Burks.  It gives a great overview of the immunotherapy clinical trials, some results they've seen, next steps, etc.  There's more information on the oral immunotherapy trials (peanut flour) than the sublingual (drops that Abigail takes) because that was the original trial, and they have 5 plus years of data.  Our doctor for the sublinugal trial has submitted a paper and hopes that it will be published soon.  We're looking forward to reading about the current successes of the sublingual study.  It's neat to know that Abigail's data is a part of those results.

Anxiety - A Symptom of Food Allergies?

Abigail's stomach started hurting 3 weeks or so after starting the Peanut Clinical Trial at Duke University.  Almost a year later, it still hurts.  Is it coincidence or a result?  I'm having a hard time answering that question.

When her belly first started hurting, it was usually dinner time or soon after at bedtime.  In the beginning, Abigail couldn't really tell me much.  Not having had a lot of stomach issues as a child, she really couldn't explain what she was experiencing.  Now she can tell me that it doesn't burn like acid indigestion nor does she feel nauseous.  It just hurts in her belly right around her belly button area.  The ache comes and goes.  She also occasionally regurgitates.

After a visit to the pediatrician and trying childrens' Pepto, Miralax and then Prilosec for a short period of time, I began to consider that her bedtime belly aches were a result of being anxious about school the next day or even not wanting to go to sleep (she's always had a good deal of bad dreams).  When she'd complain, I'd tell her to go to sleep and that it'd quit hurting.  Sounds pretty callous, but I didn't want to feed the anxiety.  I was a little concerned when one evening she started going into a full scale panic attack.  Fortunately, that's only happened once, and I learned I could distract her by talking about something fun to take her mind off of whatever she was anxious about.  At that point, my husband and I considered counseling.  After all, she's was only 6 and way too young to start having panic attacks.  However, with her belly just hurting at night, and with her somewhat being able to "manage" it by thinking of other things, I never scheduled an appointment. Well, now her belly hurts during the day as well as continuing to hurt off and on at night.

Early on, I asked our doctor at Duke, but he knew of no one else in the program that was experiencing anything similar. So, for a year I chalked it up to coincidence.  Coincidence also that she takes her drops late in the afternoon, and if her stomach hurt, it would always be dinner or bedtime, 2 to 3 hours later.  Then, I started doing research on the impact of food on Attention Deficit Disorder, something else she's showing tendencies towards, and began finding articles showing anxiety as a symptom of food allergies and/or food intolerance.  After hours of internet searching though, I'm no closer to an answer.  I can't find any link between the two on any site that I feel has high enough credentials.  I found one study done in 2001 that found a link between allergies and panic disorder but no other anxiety disorders. 

So, what now?  There is a possibility that the peanut protein drops Abigail takes on a daily basis is causing a mild allergic reaction, and as one particular article suggests, symptoms are manifesting in her weakest organ system, the nervous system, causing anxiety which in turn is causing her stomach to hurt.  It could be that subconsciously, she is more anxious about her allergy than she realizes and her stomach hurts as a result.  What if she's developed an additional food intolerance?  It's also possible that her belly is inflamed from the continuous exposure to the peanut protein and that's why it hurts.  In those cases, the anxiety is the coincidence.

Right now, I'm operating on the assumption that the last option is what is occurring.  After consultation with her pediatrician, we've started Abigail back on Prilosec.  According to her doctor, it could take 6 to 8 weeks for it to work. I didn't give it to her for that long last year when her belly first started hurting.  If it doesn't help, then our next step could be a visit to a GI doctor and an in depth conversation with our doctor at Duke. 

Please leave a comment if any of this is sounding familiar.  I'm stumped and frustrated.  There's nothing like the feeling of not being able to help your child!

Too Much Rain

We were scheduled to go to Duke yesterday for Abigail's final dose increase before hitting the maintenance stage of the trial.  After hearing the forecast, I decided to postpone our appointment until next week.  I know that sounds crazy, but the weather forecast called for heavy rain here, there and all the way in between.  It seems like every other visit to Duke I'm driving in heavy downpours, and it is miserable.  Besides, the kids are staying with my parents this weekend and will already be three quarters of the way to Duke.  Made more sense to swing by and pick up Abigail Monday morning and head to Durham as opposed to going Wednesday and then driving both Saturday to drop them off and Sunday to pick them up.  Unfortunately, Abigail will miss a day of school, but then again, she is only in the 1st grade.

So we'll go on Monday, and then not again until the end of January.  That visit is only scheduled to take 45 minutes but will be a lab visit meaning a blood draw, skin prick test and saliva collection.  Given our tract record, that visit might actually take more than 45 minutes.  After that, we don't go back until mid April when we'll discuss the logistics of the food challenge which will be the end of May.  In the meantime, I'll be checking in to find out the results of all of the food challenges prior to Abigail's.

I've attached a link to an ABC News segment.  It features Dr. Burks discussing the clinical trial research.  What's neat about the segment is that you can see where we go every visit, how the drops are administered and even see some of our great nurses.  Here's the link:

Children's Food Allergies Escalate

I'm working on my first ever product give-away.  I'm quite excited about it.  Hopefully by next week I'll have all of the details worked out.  So, visit again soon.

Another Trip...Again

Wednesday of this week we were off to Duke again for our bi-weekly visit.  I believe it's visit number 11.  It was very much a routine visit except that Abigail and I got one really good piece of news.  We are just 3 more visits away from being on the maintenance dose.  Once we hit the maintenance stage of the study, our visits are no longer bi-weekly, but will be monthly and then every 8 weeks.  That's pretty exciting for a family that drives a 300 mile day trip every other week.

By the first of December, Abigail will be taking 8 drops of the highest extract concentrate given in this study.  Here's the study protocol for the maintenance stage:

Maintenance
During the maintenance phase, your child will receive 2000 micrograms of the study extract (crude peanut extract or placebo) daily for 24 weeks at home. Your child will continue to avoid peanuts and tree nuts in his/her diet for the duration of the study.  Your child will return to the Duke Clinical Research Unit every 1-4 months for a follow up history and physical exam for the duration of the study in addition to the scheduled food challenges.

After 24 weeks we'll return for the food challenge where Abigail will be challenged up to 5 grams of peanuts (approximately 8 peanuts).  That sounds like an impossibility to me right now, and frankly, pretty scary. We'll cross that bridge when we get there.  For now, we're celebrating that soon we'll not have to go so frequently!

Four Months & Two Weeks

We had our 10th visit to Duke this week.  We've been part of the Peanut Sublinigual Clinical Trial now for 4 months and 2 weeks.  I'd like to say we were halfway done, but I can't.  We've still got over 7 months to go before we do our first food challenge.

While we were at Duke this week, a mom and son came in for their last visit before their food challenge in December.  As we get closer and closer to Abigail's challenge, there will be more weeks between visits and fewer dosage increases.  This family was up to their highest dosage and were now just going every 6 weeks.  They are going to be either the first or second participant in our study to do the food challenge.  I was all ears as Dr. Kim was describing what was going to happen on the day of the challenge.

If the kids can tolerate it, they will be given the equivalent of 6 peanuts.  The results of the first challenges that occur in December and January can really impact the study.  If the kids can tolerate the peanut flour than that's fabulous news for us.  Talk about motivation!  If there is a high failure rate, then Dr. Burks and Dr. Kim will make modifications to the study.  Not sure what that means.  Larger dosages, more frequent increases?  Worst case scenario is that we have to start over on the peanut flour study.  The doctors really don't expect that to happen though.  There has actually been an adult on a similar sublingual study who did pass the food challenge.

I asked about Abigail's blood test results from our last visit.  I wanted to find out if her IgE number had changed.  Unfortunately, the results will be locked up until the food challenge.  Even Dr. Kim will be kept in the dark.  Abigail did have another skin prick test at this visit (she did fabulous).  Dr. Kim explained how her results could actually be worse than the initial baseline.  He did 8 pricks, 5 were peanut of various strengths, 1 was the saline prick and the last two were histamine pricks (Dr. Kim thought Abigail moved so he repeated the prick).  The histamine prick serves as the control.  If there is no reaction, then the test is faulty which is what happened at our last visit.  So, we watched and waited for 15 minutes.  The histamine pricks (the two on the bottom right side of her back in the picture) immediately formed welts and large red areas around the welts.  The first 2 pricks, the higher strength peanut pricks also formed welts and red areas.  The 3rd highest strength prick formed a pimple like place and was barely worth measuring.  The 4th and 5th strength prick didn't do anything.  That's a huge change from our first test where every prick reacted.

Do we get excited??  Is she already responding to the drops?  Afterall, it's only been 4 months and 2 weeks.  I asked if it was possible for her to simply be out-growing the allergy.  According to Dr. Kim, for peanut allergies, if a child doesn't out-grow it by the age of 5, they usually don't. Okay, so I'm just a little excited.  If we hadn't had a faulty test at our last visit, I'd be a lot more excited.  I'm still hesitant to start celebrating.  However, it's hard to complain or get worked up over having to drive almost 3 hours to Duke every other week.  Instead, I feel even more blessed at having the opportunity to do this for Abigail.

What's an IgE? An Introduction....

I've been wanting to post about IgE numbers for a while, but it involves science and medicine, neither particularly strong subjects for me.  I'm on the opposite end of the spectrum with interests centering around art and design and creative thinking.  So, why even tackle the subject?  Unfortunately, it just keeps coming up.

In conversations, parents of allergic children almost always get around to telling each other what their child's IgE number and/or Class is.  It's pretty much the only definitive description we can say about an otherwise very uncertain physical condition.  My daughter is allergic to peanuts.  Her IgE number is 14.10 kU/L, and she is a Class 3.  The number is up from the last time we had her tested when she was 4.  It does not mean that she is becoming "more allergic".  Her IgE number only tells the likelihood of her having a reaction.  At a 14, I know she has a 95% chance of having a reaction if she ingests any peanut protein.  What I don't know is when or if she'll have a reaction or to what degree of severity.  I don't know if the reaction will only need an antihistamine or require the dreaded EpiPen.  I don't even know how she got her allergy or if she'll have it her entire life.  That IgE number is the only known in a very scary world of unknowns.  We parents hold onto that number.  But what is it really?

There are 3 ways to determine if someone has an allergy.  The most definitive, most expensive and most risky is a food challenge.  The patient starts with a tiny amount of food and continues to ingest until the first sign of a reaction.  If there is a reaction, then the person is allergic.  If not, they're not allergic.  Usually the amount of food is so small that a patient might just break out in hives or maybe vomit, but there is the risk of  anaphylaxis.  At Duke, whenever a food challenge is administered (at least in the clinical trials) an IV is inserted as a precaution.  Abigail is not scheduled for a food challenge until spring of 2010.

Another allergy test method is a skin prick test.  In this test, the skin is pricked and the allergen in question is applied.  If there is an allergy, the prick area swells and the skin around it gets red and itchy (almost like a mosquito bite). The test can be used for both environmental and food allergens.  While this test is uncomfortable and somewhat subjective, it is less expensive and more reliable than the next method which is the blood test.  About.com does a good job describing and comparing both of these tests in layman's terms.  According to the site, blood tests are becoming more useful in determining food allergies because they measure the specific amount of allergic antibody to a food.  The downside of blood tests, however, is they tend to give more false positives and negatives, and may indicate an elevated antibody, i.e., an allergy, which may or may not necessarily equate to an allergic reaction.  It's from the blood test that the IgE numbers and Classes are assigned. 

Blood Test (RAST, CAP-FEIA, ImmunoCAP)

The RAST test or radioallergosorbent test detects the amount of IgE that reacts specifically with a suspected or known allergen (Wikipedia).  It's an older test and many labs are using a non-radio active test like the CAP-FEIA or ImmunoCAP.  Duke University Medical Center uses the CAP-FEIA.  It's important that you know which test your doctor is using, but I'll get to that later.

So what is an IgE?  I'm using a definition from kidshealth.org for Immunoglobulin E (IgE).  It's the simplest definition I can find online.  "IgE is a type of protein in the body called an antibody. As part of the immune system, it plays a role in allergic reactions. When a person is allergic to a particular substance, such as a food or dust, the immune system mistakenly believes that this usually harmless substance is actually harmful to the body. In an attempt to protect the body, IgE is produced by the immune system to fight that particular substance. This starts a chain of events leading to allergy symptoms."  For example, airway constriction in asthma, local inflammation in eczema, increased mucus secretion in allergic rhinitis and potentially fatal drop in blood pressure as in anaphylaxis (again from Wikipedia).   However, perhaps our nurse last week at Duke explained it best.  As she described it to Abigail....the peanut soldiers think they need to fight peanuts but we're training them not to.

In a discussion with Dr. Kim at our last visit to Duke, I learned how the IgE number is determined.  Peanut protein is adhered to the inside of a test tube.  The patient's blood is then poured into the tube, left to sit for a controlled amount of time and then shaken.  The peanut antibodies in the blood will stick to the peanut protein.  In other words, the antibodies in the blood "attack" the protein in the tube much like it does in the patient's body.  The extra blood is then washed off and the blood that is attached to the protein is measured.  That amount is the IgE number.  The Class is something assigned by the particular lab running the sample.

I've found a RAST scale that I want to post.  I also want to discuss a warning about how the big laboratories use different standards when reading the results.  There's also more on the topic about what the IgE numbers actually mean, i.e., chance of out-growing the allergy and chance of having a reaction.  But, I can just picture eyes glazing over with the amount of information thus far.  So, until next time....

Today's Visit to Duke

This is going to be short because frankly, I'm exhausted.  It was a big day for us, but I knew you guys would want to know how it went.

I made a mistake in my timing of telling Abigail what today's visit would entail.  I couldn't tell her too early or she would make herself sick with worry.  She fell asleep in the car right before we got there so I didn't tell her until we were walking into the medical building.  When I told her that it might be the appointment that they do the skin test, I "forgot" to mention that they would draw blood at the same time.  I couldn't exactly carry her through the building to the clinic if she decided she wasn't going to go, right?  Besides, we were already late (I'll get to that in a minute).  She handled it well.  She commented that hopefully it wouldn't be today's visit, but then changed her mind because she had brought two of her Build-A-Bears and thought that was a good thing. 

All went smoothly until she found out about needing to draw blood.  I had a time even getting her to agree to put the numbing medicine on her arms.  She obviously hadn't had enough time to process getting stuck.  After a few tears and much discussion, we got the numbing cream on and taped up and then moved on to the skin prick test.  After more hesitation, i.e., lack of cooperation, Dr. Kim was able to do the test.  It really is painless.  He marked her back with a pen in about 8 different places then did a tiny scratch at each place with a different dosage of peanut allergen, one salt water scratch and a histamine scratch.  I believe he said that the salt water scratch was for those patients that have very sensitive skin and/or prone to excema and acts as some sort of measurement standard.  The histamine also serves as a measurement guide.  Dr. Kim explained that her reaction today should actually be worse than her reaction from the baseline skin prick test they did when we started the study.  By dosing Abigail with a daily peanut protein, her body was, for lack of better words, "agitated."  Her body would initially "over-react" to the peanut protein, but theoretically, as she took more and more of the peanut protein, her body should get accustomed to it and stop reacting, or at the very least, react less than the baseline.

While painless, a skin prick test causes major itching and discomfort.  So, with a little hand fan to help with the itching, I was poised and ready.  Nothing happened. Well, almost nothing.  All of the marks got a pimple looking place, and the third scratch mark (not even the strongest dosage scratch) got a little red around it, but compared to the first test back in May, nothing!  As to not excite anyone by thinking that we've already seen a remarkable development after just 4 months, we have to assume that it was a faulty test.  It will be repeated at our next visit.

So far, the trip has not gone very well, and it's now time for the blood draw.  Thankfully, Abigail has had some time to come to the realization that she could be brave or we could call in 4 nurses, but that either way, she was leaving there minus some blood.  First stick wasn't successful, and our nurse had to try her other arm.  Second stick hit the mark, and all was well.  At this point, my very "brave", tearless little girl is helping change out the tubes.  There were 6 in all, and she put on 4 of them.  She swears that it was a piece of cake (minus the first stick that hurt) and that next time will be no big deal.  I didn't bother to remind her that she pretty much said the same thing 4 months earlier.  To give her credit though, at our first visit to Duke her IV needle had to be inserted twice (first time the needle was too large).  She had every right to be unhappy with needing to draw blood today with that experience fairly fresh in her memory.  Our nurse loaded Abigail up with treats, and we were finally on our way home.  Abigail is showing off her two bandages in the picture.

Our 9th visit is over and done with.  Abigail is now taking 4 drops of her solution and will continue to do so every day until we go again, 2 weeks from today.  We've got another skin prick test to look forward to.

Thanks for keeping us in your thought and prayers today.  We made it through the day!  Getting ready for the trip was much easier today, and we got on the road with time to spare.  Not 2 miles from our house though, I dumped almost half a Wendy's tea in my lap, had to circle back, change clothes and clean up the car making us late yet again to our appointment.

So much for a short post

Stressful Trip to Duke

We had another appointment at Duke last week.  I had to go back and look at my last post to see if this one was our 7th or 8th trip.  The appointments are all starting to run together.  This appointment was quite uneventful in that we saw no significant reaction to the increase in drops (2 drops of 1/10 solution, up from just 1 drop) and there was no opportunity to ask her doctor questions that I could later blog about.  Abigail even ordered the same food (which is the highlight of her visit) as the last several trips.  So, why was this particular trip so stressful?

Anyone that knows me, knows that I've got a major Type A personality.  The preparation (and we all know that Type A's have to prepare) for this visit just about did me in.  It was our first appointment with Abigail being in school.  It was also preschool orientation for my 2 year old son... his first day going to school, seeing his classroom and meeting his teacher.  And, that evening, a parent meeting at his school.  One of those meetings that if you're late and the last in line for the volunteer sign ups, you end up having to either host the class Christmas party or be room parent.  You moms know what I'm talking about.  So, there was a strict time schedule for the day, and I couldn't miss a beat.  I also had to have snacks and lunch packed for the car, the "Duke" bag packed with the remaining drops, daily log, etc. for the appointment, my son's diaper bag with extras for his stay with my mom, the note for Abigail's school, and so on.  To top it off, emotionally, it was a big day because my sweet baby boy was starting preschool.  Add it all up, and I was a stressed out, sick to my stomach mess. 

Here's how it played out.  I got Abigail out the door to school at 6:50, got my son and myself packed up and to church by 9:00, got him all settled in his new class, sat through a parent orientation, swung by the church library for movies for the car trip (it's a long one), picked him up and got to Abigail's school by 10:20, checked her out and got both kids settled with snacks by 10:30, made a quick drive-thru stop for caffeine, passed out brown bag lunches (didn't stop for that) and pulled into mom's driveway at 12:15, was back out minus my son and heading to Duke by 12:30, parked and late to our appointment at 1:15, checked out of Duke at 3:10 and back to mom's house by 3:50, through the McDonald's drive-thru (yuck!) at 4:30, finally pulling into my driveway around 6:30, kids in bed by 7:15, back at the church for the preschool meeting at 7:30, home with glass of wine in hand at 8:45 and lights out at 9:45.  Minus the evening meeting, this is what I've got to look forward to every other week for the next 5 months.

I knew it wasn't going to be easy.  But, wow, how physically draining.  My husband is going to work from home once a month and take over getting our son to and from preschool.  That'll mean that he can stay at preschool the entire morning, and I can eliminate the extra packing and drop off at mom's.  Meantime, I've got to focus on the big picture, on what our family hopes to gain, on Abigail's future.

In this picture, Abigail is sporting her backpack.  This visit wasn't much fun for her either.  This summer we played games to pass the time.  This fall, instead, she has to do her homework.  Our next visit is this coming Monday.  Please keep us in your thoughts and prayers.  For me, that I don't get bogged down with the preparation details, and for Abigail, because next visit is going to be a difficult one.  She doesn't know it yet, but they're going to do a blood draw, saliva collection and skin prick test.

Sixth Trip to Duke

We went to Duke again this last week. It was our 6th trip. We got there earlier than normal so Abigail got to take her customary trip on the escalator...not once, but twice. I'm always amazed at how the little things can thrill my kids. Riding the escalator up and then down again happens to be one of those little thrills. I'm not sure Abigail fully appreciates or even understands the full extent of our participation in this trial. All she's focused on is that it's a really long drive, she gets poked and prodded (and occasionally pricked) and she has to daily be inconvenienced to take her drops. Little treats like warm bagels with cream cheese from the cafeteria and escalator rides make it tolerable. That, and the surprise books and small games that I pack in our "Duke trip" bag which, by the way, has a large Wake Forest Demon Deacon embroidered on the side. Dad, that one's for you!

At this visit, her dosage increased from 4 drops to 8 drops. Again, she had tingling in her ears and throat. Dr. Kim said that it was a frequently reported sensation for other participants. It sounds silly now, but I asked if there was any possibility that it could be a result of holding up your tongue for 2 minutes or if he felt that it was definitely a result of the drops. Definitely the drops. Again, no sign of hives.

Three other girls came in while we were there. They had all started the trial about the same time as Abigail. I'm always proud of her when she initiates a conversation and tries to make a new friend. There's only been one time though when we've seen a little boy at two different visits. Mostly, it's all new faces every time we go. It would be nice if another treat was seeing a special friend at each visit. Dr. Kim's new schedule is going to mean that we can only schedule appointments on Mondays and Wednesdays so we might start to recognize a few other participants.

Getting into a Routine

We've been to Duke now 4 times. The last visit was just yesterday on Tuesday, June 30th. It was a routine visit. We check in at the front desk and then head to the lab (pictured to the left). There Abigail's blood pressure and temperature are checked and height and weight are logged. We head to a larger room where we spend the next hour and a half. It's a community room and can be filled with lots of kids participating in the same study, their parents, a nurse and our doctor. We haven't met our new doctor yet. Our doctor for our first three visits was Dr. Bird. He was fabulous but his Fellowship ended and he left for a permanent position in another state. Abigail is quite nervous about our new doctor, but we've been reassured that he is equally nice.

She is greeted, we turn in our daily log, confirm our case number, report anything unusual and then she is examined for any unusual marks, bumps or anything that might be taken as a reaction. She is then given her new dosage. This last time, she was given 2 drops of 1/100 dilution which she holds under her tongue for 2 minutes. I'm often asked what the equivalent is in peanuts. I don't know and need to make sure to ask next visit. For the next hour and a half, she is periodically monitored. After 30 minutes she can eat which appears to be the highlight of each of the kids' visits. They get to choose off of a menu: cereal, bagels, grits for breakfast, sandwiches, chips, pretzels or cookies for lunch and there's fruit, juice and ice cream for an extra treat.

Then we wait. Moms chat, compare notes and ask lots of questions to the doctor and nurses. Kids are entertained playing with each other or watching movies. This summer we take cards and puzzles. This fall, we'll be doing homework.

One more check and then we're heading home. I expect most visits to follow this routine. On our third visit Abigail had to spit in a cup for a saliva collection. Gross for the girls...nothing but fun for the little boys. There are a few visits that require skin prick test and blood draws. She'll get a private room and extra attention at those.

We didn't see a reaction this visit. On her second visit and for several days after, her ears itched a great deal. They haven't since. I had hoped that it was a confirmation that we weren't on the placebo. Abigail's the 37th participant in this study and so far no one has seen a hive or other visible sign of a reaction until the 4th or 5th dosage increase. I was really hoping to see something at this visit. Maybe next time at the 5th visit. Of course, we've been reassured that if we don't see a small reaction, that it doesn't mean we're not getting the real stuff.

Our First Visit to Duke

Our first visit to the Duke Clinical Research Unit at Duke University Hospital was on May 18, 2009. We've since been 2 more times. I've got some catching up to do.

My first post is of an e-mail I sent to family and friends after our first visit. I've since been encouraged to document our journey in a blog. It will be my first attempt at blogging so I guess I'm embarking on 2 journeys so to speak.

Here's the e-mail....

Abigail officially started her Sublingual Immunotherapy for Peanut Allergy, or in other words, her clinical trial to hopefully decrease her allergy to peanuts.

It was a long morning that required an IV, blood work, skin prick testing and a saliva test. Abigail did fabulous! She also got her first dosage of either the crude peanut extract (we hope) or a placebo. They start with such a tiny amount (applied with a dropper under her tongue) and they don't expect a reaction until maybe the 4th or 5th trip. We'd actually get really excited if she did get a hive or some sign of reaction because we'd then know that we were getting the peanut product. We will be going to Duke every other week for a year to continue the build-up. At each visit she will receive a higher dosage. If she can tolerate it, then we take that dosage home, and she gets it every day. I have to keep a detailed log and watch her for symptoms for 2 hours after the dosage. At the end of the year, she does a food challenge which will last about 10 hours (I'll give out more details on that as we get closer). At that point, we officially find out what group she was in. If she was in the placebo group, we re-start the study with the peanut extract for another 12 months. If she was in the peanut group, then if she passes the test, we continue building up her tolerance for another 6 months ending the study at 30 months with another food challenge. If she passes that one, then we will be instructed to add peanuts to her diet and to eat a normal portion on a regular basis. I don't have to tell you guys how big a deal that would be! To go from a lifelong possible risk of death if she ingests even a tiny amount to purposely eating peanuts to maintain her tolerance.

On a side note, there is another study at Duke that started several years before this one where the children ingest peanut flour. Some of those children have finished and are now trying to decide what their favorite peanut product is because they are eating it every day. So, there are positive results. Our study is a subset of that one, overseen by the same doctor and is being conducted in an effort to find a way to better commercialize a treatment.

So, we will be traveling to and from Duke more times than I care to count in the next couple of years. Lucky for us, both sets of parents live in route so Nathaniel will not need to sit through each 2 hour visit. The staff was great. She is assigned a personal nurse at each visit that is there to pretty much coddle her. There is a huge closest full of games, puzzles and movies. They bring in a menu with snacks and such that she can order from. And there appears to be a whole social network of kids and parents. While we were there, we met 3 other little girls her age doing trials for milk and eggs allergies. I've been told by other moms with kids in the study that their children actually look forward to the visits because of all of the special attention.

Dave and I would like to thank everyone that sent us well wishes and that offered up prayers for our visit yesterday. We went in with some apprehension and lots of questions. Abigail was really brave. Considering we've only made the drive once, I can say it wasn't that bad. Ask me again in 6 months. At least we've got the summer to get into a routine.

Blessings,

Melanie


View from the parking deck. The bridge to the building is on the left.