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

NCT02141243 | Completed

• 1 other identifier: FRENOTOMY
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankyloglossia; Breast Feeding; Enlarged Labial Frenum

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (2)

Group A

EXPERIMENTAL

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.

Procedure: Lingual Frenotomy; Procedure: Labial Frenotomy; Procedure: Sham Procedure

Group B

EXPERIMENTAL

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.

Procedure: Lingual Frenotomy; Procedure: Labial Frenotomy; Procedure: Sham Procedure

Interventions

Lingual Frenotomy PROCEDURE

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.

Group A; Group B

Labial Frenotomy 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 A; Group B

Sham Procedure 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 A; Group B

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn is full term (at least 37 weeks) and otherwise in good health.
• 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.
• Mother of newborn noted to have nipple pain or difficulty with breastfeeding (LATCH score of \<7).
• Mother of newborn has intention to exclusively breastfeed newborn.
• Mother of newborn signs a written informed consent for treatment.

You may not qualify if:

• Premature newborns.
• Newborns older than 2 weeks.
• Newborns with craniofacial anomalies (i.e. cleft lip or palate).
• Newborns who are neurologically compromised.
• Mother has condition that could affect the milk supply (i.e diabetes).
• Mother of newborn is not English speaking and not able to read at least at a 6th grade level.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (13)

• 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.

  PMID: 16952598 BACKGROUND

• 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.

  PMID: 21473843 BACKGROUND

• 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.

  PMID: 17872781 BACKGROUND

• 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.

  PMID: 21768318 BACKGROUND

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

  PMID: 21608523 BACKGROUND

• 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.

  PMID: 15687461 BACKGROUND

• 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.

  PMID: 9025430 BACKGROUND

• 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.

  PMID: 8634108 BACKGROUND

• 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.

  PMID: 20308621 BACKGROUND

• 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.

  PMID: 17078281 BACKGROUND

• 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.

  PMID: 23821655 BACKGROUND

• 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.

  PMID: 16722609 BACKGROUND

• 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.

  PMID: 8176525 BACKGROUND

MeSH Terms

Conditions

Ankyloglossia; Breast Feeding

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Feeding Behavior; Behavior

Study Officials

• Pat Ricalde, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: May 19, 2014
• Study Start: May 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 12, 2019

Record last verified: 2018-05

Locations

US (1)