Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

PICO Population(s): Breastfeeding infants 6 months or less with ankyloglossia Intervention(s): Frenotomy, Frenectomy, or Frenulotomy Comparator(s): Breastfeeding management without surgical intervention Outcomes(s): Successful exclusive breastfeeding

For patients with ankyloglossia and breastfeeding difficulties, what are the comparative risks and benefits of performing the frenotomy procedure to release the tongue?

Among clinicians who perform the frenotomy procedure (pediatricians, dentists, oral surgeons, or otolaryngologists), are there variations in outcome with regard to technique?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

The comparison approach includes: Effective breastfeeding management to optimize the latch, use of breastfeeding tools and technologies such as nipple shields and milk expression and feeding by alternative means (such as a bottle). There are also variations in techniques used to perform the frenotomy.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

The population includes all infants under 6 months of age.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

There are no subgroups that apply. The disorder causes problems more often in the breastfeeding population so we can consider looking at only breastfeeding newborns. Additionally, attention should be devoted to exploring differences based on access to health services, such as insurance status, and access to professional breastfeeding support programs.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Some infants with ankyloglossia require intervention to maintain effective breastfeeding, and if left uncorrected will be unable to effectively breastfeed.

Improved breastfeeding is defined by decrease in nipple pain (using an objective maternal pain score), improved latch (sustained suckling, and ability to extend period of breastfeeding with normalized suckle to swallow pattern), and increase in milk transfer leading to improved weight gain. Frenotomies are typically considered for infants up to 6 months of age.

Describe any health-related risks, side effects, or harms that you are concerned about.

1. The cost of not managing the problem is premature weaning and non-exclusive breastfeeding, both have adverse effects on child and maternal health outcomes and lead to extra health care expenditures.
2. Additional costs include the need for treatment of maternal nipple erosion and infections resulting from suckling by infants with ankyloglossia.
3. The costs of managing the condition involve a simple outpatient minor surgical procedure. This procedure may be done by pediatric primary care physicians or specialist and are reimbursable through insurance. In addition, breastfeeding counseling should be provided at the time of the procedure and this is also typically covered through insurance if provided by the pediatric primary care professional.
4. The procedure may be done safely in an office setting. In unusual situations that preclude a simple office-based procedure a surgical day center is the venue. Pediatricians, dentists, oral surgeons, and otolaryngologists are typically the specialties that perform the procedure however there is wide variability in different communities who actually manages this problem.
5. Complications of the procedure are rare and may include pain, excessive bleeding, and infection.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Functional limitations and disability
• Obesity

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Children

Federal Health Care Program

• Medicaid
• State Children's Health Insurance Program (SCHIP)

Importance

Describe why this topic is important.

Ankyloglossia is a condition in which the tongue is limited in range of motion because of tight or short sublingual tissue referred to as the lingual frenulum. Ankyloglossia is defined by an inability to protrude the tip of the tongue beyond the lower gum line. Infants with ankyloglossia frequently have feeding difficulties (such as maternal nipple pain, poor latching). The complications of untreated ankyloglossia in the breastfeeding infant may include problems with milk transfer leading to slow weight gain and potential failure to thrive. In the mother complications may include pain in the nipple, trauma to the skin and premature weaning. Outcomes such as breastfeeding difficulties and/or pain should be assessed by validated scoring systems.

Breastfeeding exclusively at the breast is associated with decreased risk of obesity. Performing a frenotomy may increase the likelihood of successful breastfeeding and therefore may decreases the risk of obesity.

Given the overwhelming evidence that breastfeeding supports optimal health outcomes in infants, children and their mothers, it is important to recognize this problem early enough to avoid potential complications. There is no standardized clinical approach to this problem and most pediatricians have not been trained to assess and/or treat this condition. Over the past decade evidence supporting both the need to properly assess the degree of tongue tie in a standardized way, and the indications to treat using a simple surgical procedure has accumulated. However, the approach to ankyloglossia still remains very variable and clinicians need guidance to develop these evidence-based clinical skills.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

While it is considered a normal variant in most pediatric textbooks, with the rise in breastfeeding and understanding of the importance of exclusive breastfeeding, the condition is now considered to be problematic in some infants and may require intervention to maintain effective breastfeeding. A clinical guideline may be developed with the answer to this question.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

Ankyloglossia is a condition in which the tongue is limited in range of motion because of tight or short sublingual tissue referred to as the lingual frenulum. This condition occurs in 3.2% to 4.8% of the general population and up to 12.8% of infants with breastfeeding difficulties. However the approach to this problem is widely variable and many infants are weaned prematurely or have issues of weight gain because of untreated ankyloglossia.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

If the evidence supports the assessment and management of this problem and use of a procedure such as frenotomy when clinically necessary, then the American Academy of Pediatrics Section on Breastfeeding (SOBr) may use this information to develop a clinical guideline. Any breastfeeding infant determined to have ankyloglossia should be referred to and managed by licensed and qualified breastfeeding consultants and practitioners. This leaves the discipline open for lactation consultants (IBCLC's), qualified nurses, and physicians.

Describe the timeframe in which an answer to your question is needed.

A clinical guideline and evidence based approach is needed within the year.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

The question may affect reimbursement through Medicaid and inform clinicians about the need to develop community resources for referral and treatment.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

If the evidence supports the assessment and management of this problem and use of a procedure such as frenotomy when clinically necessary, then the American Academy of Pediatrics Section on Breastfeeding (SOBr) may use this information to develop a clinical guideline. Any breastfeeding infant determined to have ankyloglossia should be referred to and managed by licensed and qualified breastfeeding consultants and practitioners. This leaves the discipline open for lactation consultants (IBCLC's), qualified nurses, and physicians.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

AHRQ and AAP.