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

Primary Purpose

Ankyloglossia, Breast Feeding, Enlarged Labial Frenum

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lingual Frenotomy
Labial Frenotomy
Sham Procedure
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankyloglossia

Eligibility Criteria

undefined - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tampa General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Wong-Baker FACES Pain Rating Scale
This visual pain analog scale is used to measure breastfeeding pain experienced by the mother.
Change in LATCH score
Latch, Audible swallowing, Type of nipple, Comfort, and Hold (LATCH) Breastfeeding Quality Assessment

Secondary Outcome Measures

Full Information

First Posted
April 21, 2014
Last Updated
June 10, 2019
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02141243
Brief Title
Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.
Official Title
Randomized, Controlled Trial Evaluating Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankyloglossia, Breast Feeding, Enlarged Labial Frenum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lingual Frenotomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Labial Frenotomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Wong-Baker FACES Pain Rating Scale
Description
This visual pain analog scale is used to measure breastfeeding pain experienced by the mother.
Time Frame
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)
Title
Change in LATCH score
Description
Latch, Audible swallowing, Type of nipple, Comfort, and Hold (LATCH) Breastfeeding Quality Assessment
Time Frame
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)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pat Ricalde, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16952598
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. doi: 10.1016/j.jpedsurg.2006.05.024.
Results Reference
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PubMed Identifier
21473843
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. doi: 10.1007/BF03262789.
Results Reference
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PubMed Identifier
17872781
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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Citation
Edmunds J, Miles SC, Fulbrook P. Tongue-tie and breastfeeding: a review of the literature. Breastfeed Rev. 2011 Mar;19(1):19-26.
Results Reference
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PubMed Identifier
15687461
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. doi: 10.1542/peds.2004-2491.
Results Reference
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PubMed Identifier
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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. doi: 10.1177/089033449601200321.
Results Reference
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PubMed Identifier
8634108
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. doi: 10.1177/089033449501100419.
Results Reference
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PubMed Identifier
20308621
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.
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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.
Results Reference
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PubMed Identifier
23821655
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.
Results Reference
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Citation
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.
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Citation
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Results Reference
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Prospective Evaluation of Lingual Frenotomy in Newborns With Simultaneous Lip Tie for the Relief of Breastfeeding Pain.

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