A randomized and controlled trial to examine the impact of lingual frenotomy on bottle feeding mechanics

Backed by Nick Prater, Peter Vitruk, Scott Siegel, MD, DDS, Richard Baxter, Terry Buxton, Timothy D Voss, Randy Ligh, Chelsea Pinto, Milton Geivelis, Lynda Dean-Duru, and 128 other backers
The Oregon Clinic - Portland, Oregon
Portland, Oregon
Medicine
DOI: 10.18258/12491
$25,977
Raised of $19,600 Goal
132%
Funded on 3/22/19
Successfully Funded
  • $25,977
    pledged
  • 132%
    funded
  • Funded
    on 3/22/19

About This Project

Some babies are born with tongue-tie where an unusually short or tight band of tissue tethers the bottom of the tongue to the floor of the mouth. Babies with tongue-tie can have a hard time breastfeeding. We hypothesize that with a lingual frenotomy, a surgical procedure where the surgeon releases the tether, patients demonstrate improved upward mobility of the tongue and improved sucking mechanics. We will test this using an FDA-approved bottle that measures suck quality.

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What is the context of this research?

Tongue tie is an accepted cause of breastfeeding problems in infants. We have previously published studies demonstrating the importance of tongue tie release for improving breastfeeding outcomes. Other studies have demonstrated ultrasound visualization of tongue movement before and after lingual frenotomy. However, there are still large gaps in the understanding of the factors influencing lingual frenotomy success. While studies demonstrate improvement in breastfeeding outcomes, there are no studies demonstrating the improvement in bottle feeding outcomes when tongue tie is released.

Recently, an FDA approved bottle feeding system (NFANT labs) has been used to measure sucking mechanics in bottle fed babies, allowing for measurement of sucking pathology.

What is the significance of this project?

Conservative estimates show that approximately 5% of all infants have anterior tongue tie. Deeper, more visibly subtle cases of ankyloglossia have not been included in these incidence numbers, so the percentage of children with ankyloglossia is much higher than previously thought. Our research demonstrates that posterior tongue tie can be as problematic as anterior ties.

An available FDA-approved feeding solution allows for the measurement of infant sucking motions. This allows for detection of changes following surgical intervention. Previous ultrasound studies by Geddes show the importance of the upward movement of the tongue, but further lingual movement parameters following frenotomy have not been reported.

What are the goals of the project?

Our hypothesis is that lingual frenotomy for tongue-tied children will result in objectively measured improvement in mid-tongue elevation towards the palate.

The primary goal of this project is to record changes in sucking parameters following lingual frenotomy using the NFANT bottle feeding system. We plan to compare improvements over time between a control, non-intervention group and a frenotomy group. Secondary goals include recording validated outcomes of reflux and feeding efficiency.

The ultimate aim would be to publish this research. It would represent the first study demonstrating the improvement in frenotomy outcomes in bottle-fed babies. More importantly, it would provide the first objective evidence that lingual frenotomy changes upward movement parameters of the tongue.

Budget

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The majority of the budget goes towards the materials actually used to perform this study. Bottles from the NFANT company (www.nfant.com) are designated for one patient - data are collected locally to a tablet during feeding sessions and analyzed remotely. Each bottle costs $299. Our preliminary power analysis indicates the need to recruit 50 babies. A small portion of the study goes towards the disposable bottle supplies needed to perform the experiment.

The remaining two budget items are for payment of statistical analysis by a biostatistician (approximately 20 hours of work - this is based on the amount of statistical analysis we needed from our previous two studies) and a research assistant needed for organization of the study, data collection and data entry. Previous research assistants were medical students, and based on our previous studies, approximately 40 hours of work is anticipated.

Endorsed by

Dr Ghaheri is a visionary leader in the field of tongue tie. In his clinical practice, lecturing, teaching, and research, he has shown a tenacious ability to present the bald facts as he sees them and to back up his claims with existing research. If the research isn’t there, he will go ahead and make it happen. This project is another example of his trailblazing. Current tongue tie research sorely needs better quality studies in order to properly elucidate the benefits of frenotomy; this RCT would serve as a significant addition.
I am excited to help support Dr. Ghaheri and his team. It is important to start systematically gathering information and forming a deeper understanding of oral motor function as it relates to lingual frenulum releases. This is a huge step in the right direction for medicine, dentistry, lactation, speech and feeding professionals.
I am glad to support Dr. Ghaheri’s project because this aligns with my work and passion with babies who struggle to feed. Absolutely more research is needed in infant feeding and tongue tie and I hope more will support this research project.
Tongue tie is an area of medicine that is fraught with anecdotal evidence and provider bias. High quality, objective research is sorely needed. Dr. Ghaheri’s past work has been extremely influential, and this next project will help demonstrate the mechanics behind the sucking abnormalities seen in ankyloglossia.
This is an important project that will benefit many babies and their families. Having spent time with Dr Ghaheri and had the benefit of his expertise, I know that he is doing pioneering work in this field and this project will extend that knowledge.
Excited for this research to come to fruition. So many recommend "just bottle feeding" if breastfeeding is not going well. I hope this research will demonstrate that tongue tie affects many things and not only nursing. I believe this can be a stepping stone to providers looking at the root issue rather than just band aiding it with bottle feeding, as tongue ties can affect it too.
I believe that there is a lack of evidence between the impact of lingual frenectomy and whether or not that helps bottlefeeding babies feed efficiently. As a lactation consultant, I see many babies feeding inefficiently even when fed with a bottle and I believe that having more objective research on the subject would help professionals do a better job of helping parents as well.
Given recent questioning over whether frenotomy actually improves suck and whether it's worth treating a baby who is bottle-feeding, this project seeks to quantify changes before and after treatment to provide data towards this question. Results should help provide objective evidence for clinical decision making.
This project could have wide reaching impacts on infant feeding on a topic that sorely needs more research

Flag iconProject Timeline

We anticipate that it will take 2 months to plan for the study. Between April-May 2019, we would acquire bottles from NFANT, set up a database and hire and train a research assistant and develop the necessary forms for data acquisition during the study.

From June-August 2019, we would enroll subjects for the study, and then in August-September 2019 we would analyze the data and prepare a manuscript.

Once published, findings would be shared online at drghaheri.com and experiment.com


Feb 20, 2019

Project Launched

Apr 01, 2019

Hire research assistant

Jun 03, 2019

Begin patient accrual

Aug 05, 2019

End patient accrual

Sep 30, 2019

Submit manuscript with results

Meet the Team

Bobak Ghaheri
Bobak Ghaheri

Bobak Ghaheri

I am originally from the great land of southwestern Ohio. I did my undergraduate training in Spanish and Anthropology at The Ohio State University, and remained there for medical school. In 2002, my wonderful wife and I relocated to Portland, Oregon, where I did my residency training in otolaryngology/head and neck surgery at Oregon Health Sciences University. In 2007, I joined The Oregon Clinic, the largest multispecialty clinic in Oregon.

My clinical interest is helping babies with feeding difficulties. This desire stems from my personal experiences, where both of my daughters had significant problems breastfeeding. I was the first ENT in the United States to use an in-office laser treatment for assisting babies to latch on to the breast, in addition to treating older children and adults for certain dental and speech issues.


Project Backers

  • 148Backers
  • 132%Funded
  • $25,977Total Donations
  • $175.52Average Donation
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