A double blind, randomised,

controlled trial of tongue-tie division

and its effect on breastfeeding

Dr Janet Berry

Mr Mervyn GriffithsMr Mervyn Griffiths

Mrs Carolyn Westcott

Southampton University Hospitals NHS Trust, Hampshire

United Kingdom

Breastfeeding

• WHO recommends exclusive breastfeeding for first 6 months

• UK figures (Office for National Statistics – 2005 Infant Feeding survey)

– 78% breastfed at birth

– 35% exclusive breastfeeding at 1 week

– 7% exclusive breastfeeding at 4 months (29% any breast milk)

Tongue-ties potentially treatable cause of breastfeeding • Tongue-ties potentially treatable cause of breastfeeding difficulties

• National Institute for Health & Clinical Excellence (NICE) permits division of tongue-ties for breastfeeding

– ‘safe enough’

– ‘appears to work well enough to permit use in National Health Service’

– More evidence required

What is tongue-tie?

•Congenital

•Unusually thickened,

tightened or shortened

frenulum

•Limits movement of tongue

•Common condition•Common condition

•Estimated prevalence 3-4 %

Successful breastfeeding

• Wide gape, baby latches to areola

• Nipple, areola and breast tissue drawn deeply into infants mouth

• Nipple extends as far back as junction of hard and soft palates

• Tip of tongue covers lower gum ridge• Tip of tongue covers lower gum ridge

• Base of nipple held between upper gum ridge and tongue

• Jaw and tongue move in forwards motion

• Peristaltic wave along tongue

• Milk expressed towards back of mouth for swallowing

Problematic tongue-tie

• Inability to protrude tongue over lower gum ridge

– Incorrect latch

– Infant compresses nipple between gum ridges

– Baby ‘chomps’ instead of ‘sucks’

– Nipple not protected from gum ridge

• Restriction of peristaltic motion of tongue

– Inefficient stripping of milk

– Prolonged feeds

– Frequent feeds

Previous Southampton research

• Prospective study (n = 215)

– 57% mothers reported immediate improvement in feeding

– 2.8% minor complications, no major complications

– 40% babies slept through procedure or did not cry

– Of 60% who cried, 85% stopped within 20 seconds– Of 60% who cried, 85% stopped within 20 seconds

• Randomised Controlled Trial (n = 57)

– Tongue-tie division vs referral to lactation consultant

– Division group – 96% improved feeding

– Lactation consultant – 3.4% improved feeding

• Both subjective assessment - ? placebo effect

Other research

• Randomised prospective study

• Division vs sham division

• Division group -Significant ↓ in maternal pain

• No comment on change in feeding• No comment on change in feeding

Aim

• To investigate if a maternally reported,

subjective, immediate improvement in

breastfeeding following division of tongue-tie

is due to a placebo effectis due to a placebo effect

– Is effect sustained?

– Attempt to add objective measures of feeding

outcomes

– To add to body of evidence

Methods

• Ethics committee approved

• Southampton General Hospital October 2003 – April

2004

• Participants recruited from referrals to senior author • Participants recruited from referrals to senior author

for division of tongue-tie

• Inclusion criteria:

– Age less than 4 months

– Symptomatic of breastfeeding problem

– Tongue-tie present

MethodsInclusion criteria met

Written information givenWritten consent obtained

RandomisationSample feed

Baby to treatment room

Group A Immediate division

‘Blinded’ Assessment feed

Group B Delayed (sham) division

‘Blinded’ Assessment feed‘Blinded’ Assessment feed

Division

‘Blinded’ Assessment feed

2nd assessment feed

Telephone follow up1 day & 3 months

Telephone follow up1 day & 3 months

Tongue-tie division

• Infant taken to separate room

• Assistant swaddles and holds

baby

• Tongue-tie put on stretch

• Sterile scissor to cut tongue-tie• Sterile scissor to cut tongue-tie

• Sterile gauze swab held

underneath tongue

• Baby returned to mother and

feeding resumed

Tongue-tie division

• All babies taken to separate room

• Only difference between groups was tongue-tie

division or not

• All babies returned with gauze swab held under • All babies returned with gauze swab held under

tongue

• Care taken to ensure no visual clues e.g. blood or

unusual delays which might suggest group

• Blinding failed for 3 mothers - visible blood

• Blinding failed 4 times for observer – visible blood

Outcome measures

Immediate Subjective improvement in breastfeeding

Objective improvement in breastfeeding

Score sheet adapted from LATCH scoring system and

Infant breastfeeding assessment tool

Maternal pain analogue score

1 Day Subjective improvement in breastfeeding1 Day Subjective improvement in breastfeeding

Complications

3 months Subjective improvement in breastfeeding

Breastfeeding rates

Acceptability of procedure

Results

• 92 infants invited

• 75 Consented

– 6 pilot study (not included)

– 9 withdrawn (infant would not feed)– 9 withdrawn (infant would not feed)

– 60 breastfed babies

Results – patient characteristics

Group A n=30

Division

Group B n=30

Non-division

All infants n=60

Age:

Range

Mean

Median

6-115 days

33 days

23 days

5-111 days

28 days

23 days

5-115 days

32 days

23 daysMedian 23 days 23 days 23 days

Male : Female ratio 2.3 : 1

n = 21 : 9

1.7 : 1

N = 19 : 11

2 : 1

n = 40 : 20

Indication for division:

Difficulty with latch

Nipple pain/trauma

Inefficient feeding

All 3 symptoms

77% (n=23)

67% (n=20)

63% (n=19)

33% (n=10)

80% (n=24)

63% (n=19)

60% (n=18)

30% (n=9)

78% (n=47)

65% (n=39)

62% (n=37)

32% (n=19)

Immediate changes – quality of feed

Division Non division Total

Better 21 (78%) 14 (47%) 35

Same 6 (22%) 16 (53%) 22

Total 27 30 57

• The difference in improvement in feeding between the 2 groups is statistically significant– Chi-squared

– P = <0.02

– Confidence interval 6 to 51%

Total 27 30 57

Immediate changes - pain

• 29 mothers had pain during the sample feed

– Blinding unsuccessful in 1

– 14 immediate division

– 14 delayed division– 14 delayed division

• Change in pain score

– Immediate division -2.43 (SD +/- 1.87)

– Delayed division -1.35 (SD +/- 1.50)

– Difference not statistically significant

Immediate changes – can mothers

tell?

• Can mothers tell if you divide their baby’s tongue-tie?

– Group A 77% mothers correct

– Group B 55% mothers correct– Group B 55% mothers correct

– Overall 65% mothers correct

• Mothers accuracy appeared related to parity

– 1 or 2 babies – 61% correct (n = 44)

– 3 or 4 babies – 100% correct (n = 5)

– Small numbers!

Observer results – immediate changes

• Feeding rated as improved

– 50% Group A (divided)

– 40% Group B (not divided)

• Difference not statistically significant• Difference not statistically significant

• Observer correctly judged whether tongue-tie

divided 62% overall

– 65% Group A

– 57% Group B

Results – 1 day

• 90% improved feeding

– None worse

– 10% no improvement

– 40% improved– 40% improved

– 46.7% big improvement

– 3.3% full resolution

• Mean age of ‘full resolution’ babies 8 days

younger than ‘no improvement’ babies

Complications

• No significant complications

– 5% (n=3) small amount of bleeding at home

3 month follow up

• 90% improved feeding

– 55% full resolution of feeding problems

– 8.3% no improvement

– 2% lost to follow up

• 65% breastfed at 3 months of age

• 50% breastfed at 3 month follow up

– mean age 4.5 months

• All mothers contacted would choose to have tongue-

tie divided again if in same situation in future

Discussion

• Similar symptoms (and proportions with each symptom) to previous studies therefore this research comparable

• Mothers can detect an immediate • Mothers can detect an immediate improvement in feeding and this is a real effect, not placebo

• No significant change in pain score

– Our babies were about 4 weeks old

– Previous study babies were 2-3 days old

Discussion

• Slightly higher complication rate

– 5% compared to 3% previously

– None significant

– All infants with recorded complication were – All infants with recorded complication were

feeding better at 1 day

• All parents contacted would choose division

again

• Safe and acceptable procedure

Breastfeeding rates

• Our babies - 50% breastfed at 4.5 months

• Nationally - 29% breastfed at 4 months

– If placebo effect only our rates should be similar – If placebo effect only our rates should be similar to National average

– Motivated group of mothers

– Whether a mother continues to breastfeed remains the best measure of the success of division

Limitations

• Consistent limitation across tongue-tie

research is a lack of objective measurements

– Attempted to develop score sheet to give before

and after scoresand after scores

– Quality of latch most important measure

– In many cases latch noted to improve but

categories on score sheet too broad thus score

remained the same

In an ideal world….

• Blinded randomised controlled trial

• Mother and observer assessing feeding before and after intervention

– Over 2 normal feeds– Over 2 normal feeds

– Several hours apart

– As mother responds to usual cues for feeding

• Time consuming, costly, unlikely blinding could be successful over this period of time

When to divide?

• Correct age to divide remains a dilemma

– Too early – baby may feed well without division

– Too late – worn out mother and baby, may not

breastfeed normally long termbreastfeed normally long term

• Possibly breastfeeding advisers should be

aiming for division of tongue-tie in

symptomatic babies by 2 weeks old

Conclusions

1. Maternally reported, subjective immediate improvement in breastfeeding after division of tongue-tie is a real and not placebo effect

2. Division of tongue-tie enabled our population of mothers to achieve breastfeeding rates nearly twice the national averagetwice the national average

3. Tongue-ties are a reversible cause of breastfeeding difficulties which should be looked for by breastfeeding advisors

4. Timely intervention with tongue-tie division is simple, safe and successful

• No financial/commercial interests

• My daughter (born in 2008) had tongue-tie

divided on day 3

– Research conducted 2003-2004– Research conducted 2003-2004

Questions

• References available on request

• Please email janet.berry@wehct.nhs.uk