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. 2017 Mar 11;3(3):CD011065.
doi: 10.1002/14651858.CD011065.pub2.

Frenotomy for tongue-tie in newborn infants

Joyce E O'Shea  1 , Jann P Foster  2   3   4 , Colm Pf O'Donnell  5 , Deirdre Breathnach  6 , Susan E Jacobs  7   8   9 , David A Todd  10 , Peter G Davis  8
Affiliations

Frenotomy for tongue-tie in newborn infants

Joyce E O'Shea et al. Cochrane Database Syst Rev. .

Abstract

Background: Tongue-tie, or ankyloglossia, is a condition whereby the lingual frenulum attaches near the tip of the tongue and may be short, tight and thick. Tongue-tie is present in 4% to 11% of newborns. Tongue-tie has been cited as a cause of poor breastfeeding and maternal nipple pain. Frenotomy, which is commonly performed, may correct the restriction to tongue movement and allow more effective breastfeeding with less maternal nipple pain.

Objectives: To determine whether frenotomy is safe and effective in improving ability to feed orally among infants younger than three months of age with tongue-tie (and problems feeding).Also, to perform subgroup analysis to determine the following.• Severity of tongue-tie before frenotomy as measured by a validated tool (e.g. Hazelbaker Assessment Tool for Lingual Frenulum Function (ATLFF) scores < 11; scores ≥ 11) (Hazelbaker 1993).• Gestational age at birth (< 37 weeks' gestation; 37 weeks' gestation and above).• Method of feeding (breast or bottle).• Age at frenotomy (≤ 10 days of age; > 10 days to three months of age).• Severity of feeding difficulty (infants with feeding difficulty affecting weight gain (as assessed by infant's not regaining birth weight by day 14 or falling off centiles); infants with symptomatic feeding difficulty but thriving (greater than birth weight by day 14 and tracking centiles).

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and CINAHL up to January 2017, as well as previous reviews including cross-references, expert informants and journal handsearching. We searched clinical trials databases for ongoing and recently completed trials. We applied no language restrictions.

Selection criteria: Randomised, quasi-randomised controlled trials or cluster-randomised trials that compared frenotomy versus no frenotomy or frenotomy versus sham procedure in newborn infants.

Data collection and analysis: Review authors extracted from the reports of clinical trials data regarding clinical outcomes including infant feeding, maternal nipple pain, duration of breastfeeding, cessation of breastfeeding, infant pain, excessive bleeding, infection at the site of frenotomy, ulceration at the site of frenotomy, damage to the tongue and/or submandibular ducts and recurrence of tongue-tie. We used the GRADE approach to assess the quality of evidence.

Main results: Five randomised trials met our inclusion criteria (n = 302). Three studies objectively measured infant breastfeeding using standardised assessment tools. Pooled analysis of two studies (n = 155) showed no change on a 10-point feeding scale following frenotomy (mean difference (MD) -0.1, 95% confidence interval (CI) -0.6 to 0.5 units on a 10-point feeding scale). A third study (n = 58) showed objective improvement on a 12-point feeding scale (MD 3.5, 95% CI 3.1 to 4.0 units of a 12-point feeding scale). Four studies objectively assessed maternal pain. Pooled analysis of three studies (n = 212) based on a 10-point pain scale showed a reduction in maternal pain scores following frenotomy (MD -0.7, 95% CI -1.4 to -0.1 units on a 10-point pain scale). A fourth study (n = 58) also showed a reduction in pain scores on a 50-point pain scale (MD -8.6, 95% CI -9.4 to -7.8 units on a 50-point pain scale). All studies reported no adverse effects following frenotomy. These studies had serious methodological shortcomings. They included small sample sizes, and only two studies blinded both mothers and assessors; one did not attempt blinding for mothers nor for assessors. All studies offered frenotomy to controls, and most controls underwent the procedure, suggesting lack of equipoise. No study was able to report whether frenotomy led to long-term successful breastfeeding.

Authors' conclusions: Frenotomy reduced breastfeeding mothers' nipple pain in the short term. Investigators did not find a consistent positive effect on infant breastfeeding. Researchers reported no serious complications, but the total number of infants studied was small. The small number of trials along with methodological shortcomings limits the certainty of these findings. Further randomised controlled trials of high methodological quality are necessary to determine the effects of frenotomy.

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Conflict of interest statement

None declared.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 Frenotomy versus no frenotomy or sham procedure, outcome: 1.1 Infant breastfeeding assessed by a validated scale.
5
5
Forest plot of comparison: 1 Frenotomy versus no frenotomy or sham procedure, outcome: 1.6 Qualitative assessment of infant feeding by parental survey performed within 48 hours of the procedure.
1.1
1.1. Analysis
Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 1: Infant breastfeeding assessed by a validated scale
1.2
1.2. Analysis
Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 2: Infant breastfeeding assessed by a validated scale 2 to 7 days following procedure
1.3
1.3. Analysis
Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 3: Maternal nipple pain assessed by a validated pain scale
1.4
1.4. Analysis
Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 4: Qualitative assessment of infant feeding by parental survey performed within 48 hours of procedure
1.5
1.5. Analysis
Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 5: Excessive bleeding at the time or within 24 hours of frenotomy (as determined by study investigators)
1.6
1.6. Analysis
Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 6: Infection at the site of frenotomy requiring treatment with antibiotics within 7 days of procedure
1.7
1.7. Analysis
Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 7: Damage to the tongue and/or submandibular ducts noted within 7 days of procedure (as determined by study investigators)
See this image and copyright information in PMC

Comment in

References

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