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
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
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