Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.
NCT ID: NCT02141243
Last Updated: 2019-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2015-05-31
2018-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Group A
All participants will receive both the lingual frenotomy and sham procedure. Group A infants will receive lingual frenotomy 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.
Lingual frenotomy: tongue will be elevated, expose frenulum with a grooved director or 2 cotton tipped applicators, and then incise frenulum tissue with a straight scissor.
Sham/placebo procedure: infant brought into a procedure room and kept there for as long as the average experimental procedure would take (\~5 minutes).
Maxillary labial frenotomy: 0.1 ml of 1% lidocaine will be injected into the area, upper lip lifted, frenum stretched, and a laser, (iLaseTM 940 ± 15 nm) or scissors, will be used to release its attachment to the level of the periosteum.
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.
Group B
All participating infants will receive both the lingual frenotomy and sham procedure. Group B infants will receive the sham procedure for intervention #1 and a lingual frenotomy for intervention #2. Newborns that continue to have difficulty with breastfeeding after both interventions will undergo intervention #3, a labial frenotomy.
Sham/placebo procedure: infant brought into a procedure room and kept there for as long as the average experimental procedure would take (\~5 minutes).
Lingual frenotomy: tongue will be elevated, expose frenulum with a grooved director or 2 cotton tipped applicators, and then incise frenulum tissue with a straight scissor.
Maxillary labial frenotomy: 0.1 ml of 1% lidocaine will be injected into the area, upper lip lifted, frenum stretched, and an iLaseTM 940 ± 15 nm laser used to release its attachment to the level of the periosteum.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
2 Weeks
ALL
No
Sponsors
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University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Pat Ricalde, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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Tampa General Hospital
Tampa, Florida, United States
Countries
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References
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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. doi: 10.1016/j.jpedsurg.2006.05.024.
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. doi: 10.1007/BF03262789.
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.
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.
Edmunds J, Miles SC, Fulbrook P. Tongue-tie and breastfeeding: a review of the literature. Breastfeed Rev. 2011 Mar;19(1):19-26.
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. doi: 10.1542/peds.2004-2491.
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. doi: 10.1177/089033449601200321.
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. doi: 10.1177/089033449501100419.
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.
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.
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.
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. doi: 10.1186/1746-4358-1-3.
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. doi: 10.1111/j.1552-6909.1994.tb01847.x.
Other Identifiers
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FRENOTOMY
Identifier Type: -
Identifier Source: org_study_id
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