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Study flow diagram.

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Figure 1

Study flow diagram.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Forest plot of comparison: 1 Frenotomy versus no frenotomy or sham procedure, outcome: 1.1 Infant breastfeeding assessed by a validated scale.

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Figure 4

Forest plot of comparison: 1 Frenotomy versus no frenotomy or sham procedure, outcome: 1.1 Infant breastfeeding assessed by a validated scale.

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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.

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Figure 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.

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Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 1: Infant breastfeeding assessed by a validated scale

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Analysis 1.1

Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 1: Infant breastfeeding assessed by a validated scale

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Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 2: Infant breastfeeding assessed by a validated scale 2 to 7 days following procedure

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Analysis 1.2

Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 2: Infant breastfeeding assessed by a validated scale 2 to 7 days following procedure

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Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 3: Maternal nipple pain assessed by a validated pain scale

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Analysis 1.3

Comparison 1: Frenotomy versus no frenotomy or sham procedure, Outcome 3: Maternal nipple pain assessed by a validated pain scale

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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

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Analysis 1.4

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

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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)

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Analysis 1.5

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)

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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

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Analysis 1.6

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

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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)

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Analysis 1.7

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)

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Summary of findings 1. Frenotomy compared with no frenotomy or sham procedure in infants with tongue‐tie and feeding difficulties

Undefined

Patient or population: tongue‐tie in newborn infants
Setting: maternity hospitals
Intervention: frenotomy
Comparison: no frenotomy or sham procedure

Outcomes

Illustrative comparative risks (mean and SD)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with no frenotomy or sham procedure

Risk with frenotomy

Infant breastfeeding assessed by validated scale ‐ IBFAT scores following procedure

Mean IBFAT scores following procedure in the control group was 8.1 (SD 0.9)

Mean IBFAT scores following procedure in the frenotomy group was 11.6 (SD 0.8)

Mean difference is 3.50 (3.06 to 3.94)

58
(1 RCT)

⊕⊕⊝⊝
LOWa,b

IBFAT score is based on a 12‐point scale

Infant breastfeeding assessed by validated scale ‐ LATCH scores following procedure

Mean LATCH scores following procedure in the control group was 6.8 to 8.5 (SD < 1.9)

Mean LATCH scores following procedure in the frenotomy group was 6.8 to 8.4 (SD < 2)

Mean difference is ‐0.07 (‐0.63 to 0.48)

155
(2 RCTs)

⊕⊕⊝⊝
LOWa,b

LATCH score is based on a 10‐point scale

Maternal nipple pain assessed by a validated pain scale ‐ visual analogue pain scale

Mean visual analogue pain scale scores following procedure in the control group was 2.9 to 5.5 (SD < 2.6)

Mean IBFAT scores following procedure in the frenotomy group was 1.6 to 5.3 (SD < 2.4)

Mean difference is ‐0.74 (‐1.35 to ‐0.13)

183
(3 RCTs)

⊕⊕⊝⊝
LOWa,b

Visual analogue pain scale score is based on a 10‐point scale

Maternal nipple pain assessed by a validated pain scale ‐ SF‐MPQ pain scale

Mean SF‐MPQ scores following procedure in the control group was 13.5 (SD 1.5)

Mean IBFAT scores following procedure in the frenotomy group was 4.9 (SD 1.5)

Mean difference is ‐8.60 (‐9.37 to ‐7.83)

58
(1 RCT)

⊕⊕⊝⊝
LOWa,b

SF‐MPQ score is based on a 50‐point scale

*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI: confidence interval; OR: odds ratio; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to the estimate of effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

aImprecision (small total participant population)

bRisk of bias (incomplete blinding)

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Summary of findings 1. Frenotomy compared with no frenotomy or sham procedure in infants with tongue‐tie and feeding difficulties
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Comparison 1. Frenotomy versus no frenotomy or sham procedure

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Infant breastfeeding assessed by a validated scale Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

1.1.1 IBFAT scores following procedure

1

58

Mean Difference (IV, Fixed, 95% CI)

3.50 [3.06, 3.94]

1.1.2 LATCH scores following procedure

2

155

Mean Difference (IV, Fixed, 95% CI)

‐0.07 [‐0.63, 0.48]

1.2 Infant breastfeeding assessed by a validated scale 2 to 7 days following procedure Show forest plot

1

105

Mean Difference (IV, Fixed, 95% CI)

‐0.10 [‐0.75, 0.55]

1.3 Maternal nipple pain assessed by a validated pain scale Show forest plot

4

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

1.3.1 Visual analogue pain scale

3

183

Mean Difference (IV, Fixed, 95% CI)

‐0.74 [‐1.35, ‐0.13]

1.3.2 SF‐MPQ pain scale

1

58

Mean Difference (IV, Fixed, 95% CI)

‐8.60 [‐9.37, ‐7.83]

1.4 Qualitative assessment of infant feeding by parental survey performed within 48 hours of procedure Show forest plot

2

114

Risk Ratio (M‐H, Fixed, 95% CI)

3.48 [2.18, 5.56]

1.5 Excessive bleeding at the time or within 24 hours of frenotomy (as determined by study investigators) Show forest plot

5

302

Risk Difference (M‐H, Fixed, 95% CI)

0.00 [‐0.03, 0.03]

1.6 Infection at the site of frenotomy requiring treatment with antibiotics within 7 days of procedure Show forest plot

5

302

Risk Ratio (M‐H, Fixed, 95% CI)

Not estimable

1.7 Damage to the tongue and/or submandibular ducts noted within 7 days of procedure (as determined by study investigators) Show forest plot

5

302

Risk Ratio (M‐H, Fixed, 95% CI)

Not estimable
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Comparison 1. Frenotomy versus no frenotomy or sham procedure
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