Research Study 2019
Thank you for taking the time to consider participation in this study. Please read through this entire page - there is a lot of information here but it’s a critical step in making sure everyone has the same understanding of what is expected.
While we have previously published several studies that demonstrate improvement in breastfeeding outcomes with a tongue tie release, there is still significant debate surrounding the topic. One of the critiques is that we don’t have objective data demonstrating improvement in tongue mobility, so this study is the first of its kind to try and address that concern. If you do participate, you will be part of a study that has the potential to be one of the most impactful studies in the field of infant feeding medicine.
As an overview to this project, we want to include babies who need a tongue tie release to help breastfeeding problems who are also using the bottle as supplementation because breastfeeding isn’t going well. There can be a multitude of breastfeeding problems that demand bottle use - nipple pain/damage, poor weight gain, poor milk transfer at the breast, poor latch, etc. These are the babies we would like to study. There are babies who may be using bottles for other reasons - to allow other family members to feed the baby, convenience if out of the house, etc - these are babies we do NOT want to include in the study.
Who we include in this study is very important because there is a significant financial cost to us if we choose the wrong babies. Each baby studied costs us over $300. If a baby is incorrectly selected for the study, or more importantly, if the baby starts the study but doesn’t complete the protocol, not only do we lose their data but we lose the cost of the materials as they cannot be reused. If enough babies drop out of the study and we don’t find more money to add more babies, we may not collect data from enough babies to make the study statistically valid.
So what costs so much? The bottle that we are using is from a company called NFANT. The bottle system is pictured below. Inside the nipple of the bottle is a small purple lever. This lever can detect very small movements of the tongue as it pushes on the nipple. The bottle then has a bluetooth collar that transmits data real time to a tablet, which records specific waveforms. What we plan to do is to measure those movements before and after the procedure to see if the bottle can detect those changes in tongue movement - this would gives us objective data demonstrating how a tongue tie release changes those tongue movements.
There are specific requirements to be included in this study:
the baby needs to be 3-16 weeks of age at the time of the initial visit in the office
you must be willing to travel to the Gresham office (24076 SE Stark St, Gresham OR 97030) - this is the only office where the study is being done. There will be 2 or 3 visits that must be done in person.
you must meet the criteria of why your baby is using the bottle (mentioned above) - again, we are looking for babies who are using a bottle because breastfeeding isn’t going well
the baby cannot have any major health problems (heart, lung, brain, airway, etc)
the baby cannot have been born premature (before 37 weeks gestation)
the mom/baby must have already worked with an international board certified lactation consultant (IBCLC) prior to the initial visit
the baby cannot be a twin/triplet
the baby cannot have a lip tie that needs treatment (this can be determined at the visit and will not delay treatment)
If you meet these criteria and want to proceed, the most important thing to understand is that this participation is voluntary. If you do not think you can fulfill the whole protocol, please let the office know before we use the bottle on your baby - we can quickly reschedule you to a non-study office visit and treat your baby expeditiously.
The major critique of our previous studies is that we did not have a control group. What does that mean? A control group is a vital part of measuring the impact of a procedure - basically, we split the group of babies into two groups. One group gets treated on the day of the initial consultation and the other group waits 10 days before getting treated. What that means is that your baby has a 50/50 chance of being selected to wait 10 days before getting the surgical release done. If your symptoms or the baby’s symptoms are severe enough that you cannot accept that risk, please do not participate in the study. If you make the appointment for the study and at the visit, you get the random choice of being in the WAIT group, and you ask to be treated on that day, we cannot include you in the study, which will take up a spot that is dedicated to study participants.
Here is what it would look like if you participate:
All initial visits are on Tuesday mornings in the Gresham office (24076 SE Stark #230, Gresham OR 97030). It is very important that you try and bring the baby to the office when hungry. If the baby feeds right before you get there, we can’t get any measurements on the bottle. Ideally, 90 minutes or longer would improve our chances of getting a good reading.
Group 1: you show up to the office and are selected for the treatment group. Your baby will first feed on the bottle for several minutes to capture the data BEFORE the procedure. We then do the procedure and will try and have the baby feed again on the bottle to see if the bottle can detect any immediate changes in tongue motion. You will then email a picture of the wound 5 days after the procedure to check wound healing. On day 10 after the procedure, you will return to the office (Friday afternoon in Gresham) where I will check the wound again and the baby will feed on the bottle to see if there are any changes compared to the pre-procedure readings. This would be your only other appointment - in total, it would be one initial visit, then one email, and then one return visit (two office visits total)
Group 2: you show up to the office and are selected for the observation group. Your baby will feed on the bottle for several minutes to capture the data as a baseline reading. No procedure will be done that day. You will then come back 10 days later (Friday afternoon in Gresham) where we will get another feeding on the bottle (this is the feeding we will compare to the babies who had a procedure 10 days earlier). We will then do the procedure and come back to the room where another feeding is attempted to see if the bottle can detect any immediate changes in tongue motion. You will then email a picture of the wound 5 days after the procedure to check wound healing. On day 11 after the procedure, you will return to the office (Tuesday morning in Gresham) where I will check the wound again and the baby will feed on the bottle to see if there are any changes compared to the pre-procedure readings. In total, it would be one initial visit, one return visit (procedure day), one email and then one last visit to check how feeding is 11 days after the procedure (three office visits total).
As if all of that isn’t enough, we will also be collecting questionnaire data on any breastfeeding changes for before/after the procedure. You will be asked to do these questionnaires once before the procedure and once after the procedure.
If you’ve read through all of this and think you can help us, the only other step is to email me a picture of the baby’s tongue and lip before we can schedule the appointment. There are several “kinds” or categorizations of tongue tie. The obviously visible tongue ties that bind the front of the tongue are not the babies we are interested in treating. We are interested in babies with posterior tongue tie - to get that picture, please follow the guide on how to properly take a picture - when you email this picture to email@example.com, please put make the subject heading “TT Study Approval Picture”. Please also include a picture of the underside of the upper lip. If approved, the office will call you to schedule the appointment.
Thank you again for your consideration in the study. Please let the office know if you have any questions.