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Cochrane Database of Systematic Reviews

Frenotomy for tongue‐tie in newborn infants

Information

DOI:
https://doi.org/10.1002/14651858.CD011065.pub2Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 11 March 2017see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:

  1. Cochrane Neonatal Group

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Joyce E O'Shea

    Correspondence to: Royal Hospital for Children, Glasgow, UK

    joyce.o'[email protected]

    [email protected]

  • Jann P Foster

    School of Nursing and Midwifery, Western Sydney University, Penrith DC, Australia

  • Colm PF O'Donnell

    Department of Neonatology, National Maternity Hospital, Dublin 2, Ireland

  • Deirdre Breathnach

    Campaspe Family Practice, Kyneton, Australia

  • Susan E Jacobs

    Neonatal Services, The Royal Women's Hospital, Parkville, Melbourne, Australia

    The University of Melbourne, Melbourne, Australia

    Murdoch Childrens Research Institute, Parkville, Australia

  • David A Todd

    Neonatal Unit, The Canberra Hospital, Canberra, Australia

  • Peter G Davis

    Newborn Research Centre and Neonatal Services, The Royal Women’s Hospital, Melbourne, Australia

    Murdoch Children's Research Institute, Melbourne, Australia

    Department of Obstetrics and Gynecology, University of Melbourne, Melbourne, Australia

Contributions of authors

CO'D and DB wrote the first draft of the protocol.
JO'S and JF wrote subsequent drafts of the protocol.
PD, SJ, DT and CO'D commented on and reviewed the protocol.

JO'S and JF wrote the review. PD, SJ, DT and CO'D commented on and reviewed the review.

Sources of support

Internal sources

  • The Royal Women's Hospital Foundation, Parkville, Melbourne, Australia, Other

External sources

  • NMHRC Program Grant, Australia

    Part of Dr O'Shea's salary

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, USA

    Editorial support for the Cochrane Neonatal Review Group has been funded with Federal funds from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, USA, under Contract No. HHSN275201600005C

  • National Institute for Health Research, UK

    Editorial support for the Cochrane Neonatal Review Group has been funded with funds from a UK National Institute of Health Research Grant (NIHR) Cochrane Programme Grant (13/89/12). The views expressed in this publication are those of the review authors and are not necessarily those of the NHS, the NIHR or the UK Department of Health

Declarations of interest

None declared.

Acknowledgements

Thank you to the newborn research team at the Royal Women's Hopsital for support throughout this project.

Version history

Published

Title

Stage

Authors

Version

2017 Mar 11

Frenotomy for tongue‐tie in newborn infants

Review

Joyce E O'Shea, Jann P Foster, Colm PF O'Donnell, Deirdre Breathnach, Susan E Jacobs, David A Todd, Peter G Davis

https://doi.org/10.1002/14651858.CD011065.pub2

2014 Apr 14

Frenotomy for tongue‐tie in newborn infants

Protocol

Joyce E O'Shea, Jann P Foster, Colm PF O'Donnell, Deirdre Breathnach, Susan E Jacobs, David A Todd, Peter G Davis

https://doi.org/10.1002/14651858.CD011065

Differences between protocol and review

We added to this review the methods and plan for 'Summary of findings' tables and GRADE recommendations, which were not included in the original protocol.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Female; Humans; Infant, Newborn;

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram.

Figures and Tables -
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.

Figures and Tables -
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.

Figures and Tables -
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.

Figures and Tables -
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.

Figures and Tables -
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

Figures and Tables -
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

Figures and Tables -
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

Figures and Tables -
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

Figures and Tables -
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)

Figures and Tables -
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

Figures and Tables -
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)

Figures and Tables -
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)

Figures and Tables -
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
Figures and Tables -
Comparison 1. Frenotomy versus no frenotomy or sham procedure
Navigate to table in Review