Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.

Breast Feeding Clinical Trial

Official title:

Randomized, Controlled Trial Evaluating Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141243
• Other study ID #: FRENOTOMY
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We are proposing to conduct a randomized, controlled trial of newborns in the maternal infant care areas at Tampa General Hospital. Participants who are determined eligible for the study (classified to have ankyloglossia via the HATLFF and either a Class III or IV maxillary labial frenum) will be randomly assigned to one of two groups: Group A or Group B. Group A will receive a sham procedure for intervention #1 and a lingual frenotomy procedure for intervention #2. Group B will receive a lingual frenotomy procedure for intervention #1 and a sham procedure for intervention #2. Newborns that continue to have difficulty with breastfeeding after both interventions will undergo intervention #3, a labial frenotomy, and breastfeeding will be monitored afterwards.

Description:

The study is a randomized control studies which aims to contribute data to a previous study on the effects of ankyloglossia (tongue-tie) on breastfeeding, and to also provide new information on the effects of maxillary lip-tie on breastfeeding. Participants who are determined eligible for the study (classified to have ankyloglossia via the HATLFF and either a Class III or IV maxillary labial frenum) will be randomly assigned to one of two groups: Group A or Group B. Group A will receive a sham procedure for intervention #1 and a lingual frenotomy procedure for intervention #2. Group B will receive a lingual frenotomy procedure for intervention #1 and a sham procedure for intervention #2. Newborns that continue to have difficulty with breastfeeding after both interventions will undergo intervention #3, a labial frenotomy, and breastfeeding will be monitored afterwards. These results will be analyzed to determine when lingual frenotomies, labial frenotomies, or both are necessary to improve breastfeeding pain and LATCH scores.

The study aims to prove that the simple and low risk frenotomy procedure should be considered as treatment for both ankyloglossia and maxillary lip-tie, preventing breastfeeding complications as well as many other future problems such as with speech and self esteem. It is hypothesized that the use of frenotomies as treatment for ankyloglossia and maxillary lip-tie will improve breastfeeding success for breastfeeding couplets with newborns with both ankyloglossia and maxillary lip-tie. It is expected to see an increase in LATCH score to >7 for breastfeeding sessions and a significant decrease in scoring on the pain scale after frenotomy intervention, while it is expected to see little change in LATCH and pain scale assessment scores after sham procedures. Overall data is not expected to vary significantly between Group A and Group B. It is also hypothesized that a lingual frenotomy alone will be sufficient to improve breastfeeding success without the need to also conduct a labial frenotomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

Inclusion Criteria:

1. Newborn is full term (at least 37 weeks) and otherwise in good health.

2. Newborn exhibits having ankyloglossia (score of less than 11 with failing lactation management or an appearance score lower than 8, based on HATLFF) and a Class III or Class IV maxillary lip-tie, simultaneously.

3. Mother of newborn noted to have nipple pain or difficulty with breastfeeding (LATCH score of <7).

4. Mother of newborn has intention to exclusively breastfeed newborn.

5. Mother of newborn signs a written informed consent for treatment.

Exclusion Criteria:

1. Premature newborns.

2. Newborns older than 2 weeks.

3. Newborns with craniofacial anomalies (i.e. cleft lip or palate).

4. Newborns who are neurologically compromised.

5. Mother has condition that could affect the milk supply (i.e diabetes).

6. Mother of newborn is not English speaking and not able to read at least at a 6th grade level.

Related Conditions & MeSH terms

• Ankyloglossia
• Breast Feeding
• Enlarged Labial Frenum

Intervention

Procedure:
• Lingual Frenotomy
For newborns receiving the ankyloglossia frenotomy, the tongue will be elevated and the frenulum exposed with a grooved director or 2 cotton tipped applicators. The frenulum tissue will then be incised with a straight scissor. If thick, it will be crushed with a straight clamp to provide anesthesia and decrease bleeding, and the exposed and previously clamped tongue frenulum will be incised with a straight scissor.
• Labial Frenotomy
For newborns receiving the maxillary labial frenotomy, 0.1 ml of 1% lidocaine will be injected into the area. The upper lip will be lifted and the frenum stretched. Then an iLaseTM 940 ± 15 nm laser will be used to release its attachment to the level of the periosteum.
• Sham Procedure
For newborns receiving the maxillary labial frenotomy, 0.1 ml of 1% lidocaine will be injected into the area. The upper lip will be lifted and the frenum stretched. Then an iLaseTM 940 ± 15 nm laser will be used to release its attachment to the level of the periosteum.

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (13)

Amir LH, James JP, Donath SM. Reliability of the hazelbaker assessment tool for lingual frenulum function. Int Breastfeed J. 2006 Mar 9;1(1):3. — View Citation

Bagga S, Bhat KM, Bhat GS, Thomas BS. Esthetic management of the upper labial frenum: a novel frenectomy technique. Quintessence Int. 2006 Nov-Dec;37(10):819-23. — View Citation

Buryk M, Bloom D, Shope T. Efficacy of neonatal release of ankyloglossia: a randomized trial. Pediatrics. 2011 Aug;128(2):280-8. doi: 10.1542/peds.2011-0077. Epub 2011 Jul 18. — View Citation

Dollberg S, Botzer E, Grunis E, Mimouni FB. Immediate nipple pain relief after frenotomy in breast-fed infants with ankyloglossia: a randomized, prospective study. J Pediatr Surg. 2006 Sep;41(9):1598-600. — View Citation

Edmunds J, Miles SC, Fulbrook P. Tongue-tie and breastfeeding: a review of the literature. Breastfeed Rev. 2011 Mar;19(1):19-26. Review. — View Citation

Gartner LM, Morton J, Lawrence RA, Naylor AJ, O'Hare D, Schanler RJ, Eidelman AI; American Academy of Pediatrics Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2005 Feb;115(2):496-506. — View Citation

Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. — View Citation

Kotlow L. Diagnosis and treatment of ankyloglossia and tied maxillary fraenum in infants using Er:YAG and 1064 diode lasers. Eur Arch Paediatr Dent. 2011 Apr;12(2):106-12. Review. — View Citation

Kotlow LA. Diagnosing and understanding the maxillary lip-tie (superior labial, the maxillary labial frenum) as it relates to breastfeeding. J Hum Lact. 2013 Nov;29(4):458-64. doi: 10.1177/0890334413491325. Epub 2013 Jul 2. — View Citation

Kotlow LA. The influence of the maxillary frenum on the development and pattern of dental caries on anterior teeth in breastfeeding infants: prevention, diagnosis, and treatment. J Hum Lact. 2010 Aug;26(3):304-8. doi: 10.1177/0890334410362520. Epub 2010 Mar 22. — View Citation

Masaitis NS, Kaempf JW. Developing a frenotomy policy at one medical center: a case study approach. J Hum Lact. 1996 Sep;12(3):229-32. — View Citation

Segal LM, Stephenson R, Dawes M, Feldman P. Prevalence, diagnosis, and treatment of ankyloglossia: methodologic review. Can Fam Physician. 2007 Jun;53(6):1027-33. Review. — View Citation

Wiessinger D, Miller M. Breastfeeding difficulties as a result of tight lingual and labial frena: a case report. J Hum Lact. 1995 Dec;11(4):313-6. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Wong-Baker FACES Pain Rating Scale	This visual pain analog scale is used to measure breastfeeding pain experienced by the mother.	after breastfeeding before intervention #1, after breastfeeding after intervention #1, after breastfeeding after intervention #2, and during 1 week follow-up (also after intervention #3 if applicable)
Primary	Change in LATCH score	Latch, Audible swallowing, Type of nipple, Comfort, and Hold (LATCH) Breastfeeding Quality Assessment	after breastfeeding before intervention #1, after breastfeeding after intervention #1, after breastfeeding after intervention #2, and during 1 week follow-up (also after intervention #3 if applicable)