The tongue remains with in the boundaries of the mandible during
suckling and so it is difficult to see the anatomical or the physiological
basis for how a frenulectomy works in reducing breast and nipple
discomfort during feeding. This randomised trial does not seem to assess
the potential, positive psychological impact of the mother being told
their child has had a frenulectomy. That is the question that...
The tongue remains with in the boundaries of the mandible during
suckling and so it is difficult to see the anatomical or the physiological
basis for how a frenulectomy works in reducing breast and nipple
discomfort during feeding. This randomised trial does not seem to assess
the potential, positive psychological impact of the mother being told
their child has had a frenulectomy. That is the question that must be
answered before a procedure performed on the most sensitive organ in the
body, with out anaesthesia is undertaken routinely.
Tongue tie is not proven to impact upon speech and if a release is
performed in a child with a small chin, with or without a cleft palate, it
can cause airway obstruction. A significant tongue tie causes social
embarrassment in later life but it has no other proven physical impact on
the child and so more concrete evidence of benefit for the procedure being
performed upon a neonate, with out anaesthesia, must be provided before
the practice is offered routinely. Every surgical procedure has
complications and surely there must be greater proof of benefit than
relieving nipple pain in the mother? When else is a procedure inflicted
on any patient, let alone a child, for the benefit of reducing discomfort
in a third party? With out this additional proof, practitioners may well
be performing unnecessary procedures on a defenceless infant.
With out a "sham" group, the psychological impact on the mother
cannot be excluded.
Lawson's editorial and Emond and colleagues' article exposes
potentially bad medicine: lack of knowledge of normal and variations of
normal; lack of knowledge of the natural history of a condition; a desire
to do something - Ulysses syndrome (1); medicalising the child by giving
the condition a name; and then ascribing any improvement to the
intervention, forgetting that association does not mean causation.
Lawson's editorial and Emond and colleagues' article exposes
potentially bad medicine: lack of knowledge of normal and variations of
normal; lack of knowledge of the natural history of a condition; a desire
to do something - Ulysses syndrome (1); medicalising the child by giving
the condition a name; and then ascribing any improvement to the
intervention, forgetting that association does not mean causation.
This writer did many years of community child health clinics seeing
babies with a variety of problems that never went near a hospital: a W-
shaped tongue [M-shaped from the baby's perspective] is a normal finding.
To describe it as tongue tie and to intervene are medicalising normality
in the majority of cases. As Illingworth says in The Normal Child (2)
[which should be required reading for all health professionals involved
with children] "The tongue is always short at birth but as the infant
grows the tongue becomes longer and thinner. Many mothers [and health
professionals - my insertion] ascribe their children's feeding
difficulties and lateness in speaking to tongue tie".
Unfortunately blaming tongue tie becomes self-perpetuating. The fact
that parents want subsequent children to have a frenotomy after their
first child has had one and doctors acquiesce to this or lactation experts
believe it is the cause of breastfeeding difficulties does not represent
proof nor does it justify performing the operation. Countries with
initial and sustained high breastfeeding rates such as New Zealand, where
this writer worked for several years, do not have high rates of frenotomy
to ensure that breastfeeding is successful. Rather it is good
breastfeeding support.
Recently a tongue-tie service was set up in my local area. I can
predict the outcome. In 12 months' time those who promoted and run the
service will announce how many tongue tie operations they done, how
parents are pleased and feel the baby is feeding better and how
"successful" the service is. The specious conclusion will be that tongue
tie was a significant problem for these babies which frenotomy cured. I
consider this is 21st Century charlatanism.
Signed
Dr Charles Essex
Consultant Neurodevelopmental Paediatrician
Suite 115
41 Oxford Street
Leamington Spa CV32 4RB
References
1. Essex C. Ulysses syndrome. BMJ 2005; 330: 1268.
2. Illingworth RS. The Normal Child. Churchill Livingstone, Edinburgh
1983.
We read Val Finigan's letter with interest, and agree with her
experience that most mothers do report an improvement in the comfort and
efficacy of breastfeeding after their baby has had a frenotomy. The
difficulty is in showing objective improvement in breastfeeding after
division of less severe degrees of tongue tie.
In the Bristol Tongue Tie Trial, the median age of the babies at...
We read Val Finigan's letter with interest, and agree with her
experience that most mothers do report an improvement in the comfort and
efficacy of breastfeeding after their baby has had a frenotomy. The
difficulty is in showing objective improvement in breastfeeding after
division of less severe degrees of tongue tie.
In the Bristol Tongue Tie Trial, the median age of the babies at
recruitment was 5 days, and the median age at follow-up for the primary
outcome was 11 days. We are now planning a larger trial of frenotomy,
involving all degrees of tongue tie, with a primary outcome 2 weeks after
recruitment, using a more detailed tool to assess breastfeeding.
For more information on the proposed trial design, please contact
alan.emond@bristol.ac.uk
Yours sincerely,
Alan Emond
Jenny Ingram
Centre for Child and Adolescent Health, University of Bristol
I am writing to express my concern regarding the discordance between the results and conclusions of this paper. The paper compares a point of
care glucose measurement with a laboratory "gold standard". The results
are presented in a number of forms (and with no consistency regarding
units of measurement). The error-grid analysis is unhelpful as high
levels will be high and low levels will be low for both methods and the
scale...
I am writing to express my concern regarding the discordance between the results and conclusions of this paper. The paper compares a point of
care glucose measurement with a laboratory "gold standard". The results
are presented in a number of forms (and with no consistency regarding
units of measurement). The error-grid analysis is unhelpful as high
levels will be high and low levels will be low for both methods and the
scale of the graph is too large to see what the real differences are. The
"accurate estimate zone" includes potential values 4mmol/l above and below
zero in the lower glucose range.
Whilst the authors are to be applauded for inserting a Bland Altman plot,
this plot demonstrates "limits of agreement" which are around 0.5mmol/l
above and below the line of zero. 6 points lie outside the limits of
agreement with the extremes being 0.7mmol/l above and below zero.
Therefore the plot demonstrates that in an unpredictable manner the
glucometer may be over reading or under reading by a value as great as
0.7mmol/l. This is not of clinical significance in the normoglycaemic or
hyperglycaemic range, but acquires clinical significance when blood
glucose levels are low. For example if a glucometer reading is 2.0mmol/,
the accurate level (at the extreme) could be 1.3-2.7mmol/l which will
result in over diagnosis and treatment or under diagnosis and treatment.
The authors state in the results section that the plot shows "good
correlation", but the plot does not represent correlation, and the
agreement between the values is not good.
The conclusion that there is good "correlation" between the glucometer and
the laboratory measurement draws on the wrong statistical method.
Correlation does not provide accuracy data. Under "what this study adds"
it is stated that the glucometer provides accurate results and is suitable
for measuring glucose levels in premature infants. I suggest that the
results as plotted on Bland Altman plot are directly counter to this
conclusion.
Randomised controlled trial of early frenotomy in breastfed infants
with mild-moderate tongue-tie. Edmond et al (2014)
Dear Editor,
I read this report on frenotomy to support breastfeeding with great
interest as currently there is limited evidence to support this procedure.
The outcomes contrast considerably with my own experience and audit data,
particularly with regard to persistence of breastfeeding for more...
Randomised controlled trial of early frenotomy in breastfed infants
with mild-moderate tongue-tie. Edmond et al (2014)
Dear Editor,
I read this report on frenotomy to support breastfeeding with great
interest as currently there is limited evidence to support this procedure.
The outcomes contrast considerably with my own experience and audit data,
particularly with regard to persistence of breastfeeding for more than 5
days with painful breast and objective improvement in breastfeeding at 5
days. Of course, it is not uncommon for mothers and babies to attend for
frenotomy after 5 days as time is needed to learn the art and skill of
breastfeeding before intervention, but that was not the scope of this
report. That mothers report improved self-efficacy after frenotomy
certainly fits with my experience and data, but I find that most continue
to breastfeed as their babies can latch, and both enjoy breastfeeding post
-frenotomy.
I have run frenulotomy clinics for the north west region of England for
six years, using validated assessment tools for frenulotomy , latch, self-
efficacy and pain. The women's experience of feeding is assessed pre-
operatively and immediately post-frenulotomy, and then by telephone at 24-
48 hours and again at 3 months. Of 2048 babies that were in need of
frenuotomy (November 2008 to January 2014), 62.7% of had 100% tongue-tie
(to the tip of the tongue), 12.2% had 75% tongue-tie, and 15.7% had a
posterior tongue-tie. All were referred for assessment and division by a
person skilled in infant feeding and following support with positioning
and attachment to improve breastfeeding. If the baby was formula milk-fed
by bottle, the referring practitioner had provided support with the
technique. Assessment carried out by two International Board Certified
Lactation Consultants indicated that the babies referred with notable
feeding challenges had limitations when extending, lifting and
lateralising their tongues.
Following frenotomy, 96% of mothers reported an immediate difference with
feeding. For example, breastfeeding mothers reported reduction in pain,
improved latch was noted, and later improved contentment and in some cases
weight gain. Bottle-feeding mothers suggested improvements such as baby
not chomping on the teat, no spurting of milk from the sides of the baby's
mouth, and more controlled and faster feeding.
At 48 hours, 71% of mothers who responded continued to experience improved
feeding, 29% of the sample either did not answer the phone, or were
already managing problems such as fungal infections, sore nipples or low
milk supply that would take time to resolve. At 3 months the sample size
was poor: only 21% of mothers answered the call. Yet 43% of this group
were continuing with exclusive breastfeeding and suggested that without
frenulotomy they would not have achieved this.
A study to provide stronger evidence of these outcomes is being submitted
for funding, and a comparison of results will be interesting. The reasons
for differences in outcomes will be important in enhancing frenulotomy
and breast-feeding support services.
Dr Val Finigan MBE
Consultant Midwife infant feeding
Pennine Acute NHS Hospitals Trust
Rochdale Road
Oldham
OL1 2JH
Sirs, we were surprised to read that11 out of 56 units in the
resource rich UK did not administer Rotavirus vaccine to their babies. (1)
Thirty years ago, one of us described a neonatal rotavirus outbreak that
had a considerable morbidity (2). Although these outbreaks continue(3.),
some low resource units like ours (Birth rate 3000/year) are accredited as
Breast Feeding Friendly and have adopted a very enthusiastic breast...
Sirs, we were surprised to read that11 out of 56 units in the
resource rich UK did not administer Rotavirus vaccine to their babies. (1)
Thirty years ago, one of us described a neonatal rotavirus outbreak that
had a considerable morbidity (2). Although these outbreaks continue(3.),
some low resource units like ours (Birth rate 3000/year) are accredited as
Breast Feeding Friendly and have adopted a very enthusiastic breast
feeding friendly initiative. See Compliance with the Baby-Friendly
Hospital Initiative and impact on breastfeeding rates (4) In comparison to
the high resource US units of Summer Sherburne Hawkins's study, our units
have 100% compliance. Probably because our initiative was spearheaded by
the pediatricians in charge (RT). All the students and staff in the
nursery and maternity unit endorsed it. All babies irrespective of birth
weight (700 g upwards) and gestation (27 weeks) get exclusively breast
fed, or expressed raw breast milk from birth onwards. No artificial milks
or fortifiers are used. There are no bounty boxes, advertising, or free
samples endorsing bottle feeding. And no rotavirus immunization. Since
then, there have been no outbreaks of diarrhoeal disease or necrotising
entercolitis in either unit. So, a UK neonatologist faced with the choice
to immunize or not, may have a cost effective and low resource
alternative..
Dr John Dearlove, paediatrician, Dr Rosemary Taun, Director of paediatric
services, Port Vila Central Hospital, Port Vila, Vanuatu.
References
1. Jaques S, Bhojnagarwala B, et al Slow uptake of rotavirus
vaccination in UK neonatal units.Arch Dis Child Fetal Neonatal Ed 2014
March 4, 2014 as 10.1136/archdischild-2014-306067
2.Dearlove J C,.Latham P. Et al. Clinical range of neonatal rotavirus
gastroenteritis Br Med J (Clin Res
Ed) 1983;286:1473
3. de Villiers FP , Driessen M. Clinical neonatal rotavirus
infection: association with necrotising enterocolitis.S Afr Med J. 2012
Jun 6;102(7):620-4.
4. Summer Sherburne Hawkins, Ariel Dora Stern et al2, Compliance
with the Baby-Friendly Hospital Initiative and impact on
breastfeeding rates. Arch Dis Child Fetal Neonatal Ed 2014;99:F138-F143
doi:10.1136/archdischild-2013-304842
Sir, we thank Professor Bertino and his colleagues for their interest
in our paper. We too were struck by the existence of a peak in relative
weight velocity (g/kg/d) at 30-35 weeks postmenstrual age. It is striking
that the timing of the peak is broadly the same irrespective of gestation
- neonates born at 23 weeks take 10 weeks or so to reach peak velocity,
whereas those born at 31 weeks reach their peak in only 2-3 wee...
Sir, we thank Professor Bertino and his colleagues for their interest
in our paper. We too were struck by the existence of a peak in relative
weight velocity (g/kg/d) at 30-35 weeks postmenstrual age. It is striking
that the timing of the peak is broadly the same irrespective of gestation
- neonates born at 23 weeks take 10 weeks or so to reach peak velocity,
whereas those born at 31 weeks reach their peak in only 2-3 weeks. Of
course these are average figures, and individuals vary considerably in
their age at peak velocity, and this may be a risk factor for later
adverse outcomes over and above their gestational age.
T J Cole and H Pan
Centre for Paediatric Epidemiology and Biostatistics, UCL Institute of
Child Health, London, UK
Y Statnikov, S Santhakumaran and N Modi
Imperial College London, Section of Neonatal Medicine, London, UK
At the end of this helpful review the Guideline is unclear, and
potentially harmful, regarding Vitamin D supplementation.
The phrase: "If no increase in phosphate levels and ALP continues to rise,
consider" suggests that otherwise Vitamin D supplements should not be
considered. The AAP guidance quoted, as well as clear guidance now in the
UK from the Chief Medical Officers, the RCPCH and the British Paediatric
and Adolesc...
At the end of this helpful review the Guideline is unclear, and
potentially harmful, regarding Vitamin D supplementation.
The phrase: "If no increase in phosphate levels and ALP continues to rise,
consider" suggests that otherwise Vitamin D supplements should not be
considered. The AAP guidance quoted, as well as clear guidance now in the
UK from the Chief Medical Officers, the RCPCH and the British Paediatric
and Adolescent Bone Group is that babies with many other risk factors
should have Vitamin D supplements (eg babies born to Vitamin D deficient
mothers).
More importantly the suggestion that "ergocalciferol or alphacalcidol" be
considered is wrong. Ergocalciferol (vitamin D2) or cholecalciferol
(Vitamin D3) are similar and should be considered. Alphacalcidol is a
potent activated form of Vitamin D and should only be used with caution
and by metabolic bone physicians or endocrinologists. Vitamin D dose
recommendations vary between experts and national policies because little
pharmacological data is available yet. In a neonatal unit these doses can
be increased as long as the recommended monitoring suggested in this paper
is followed (weekly blood bone profile). If hypercalcaemia develops
Vitamin D supplements should be stopped until the blood Vitamin D and
Parathyroid hormone levels are known.
Enrico Bertino (1), Silvano Milani (2), Elena Spada (2)
(1). Department of Public and Pediatric Health Sciences - Neonatal
Unit, Universita' degli Studi di Torino
(2). Department of Clinical Sciences and Community Health - Unit of
Medical Statistics & Biometry, Universita' degli Studi di Milano
Sir, we have read with great interest the paper by Cole et al. (1) on
the longitudinal growth in infants bo...
Enrico Bertino (1), Silvano Milani (2), Elena Spada (2)
(1). Department of Public and Pediatric Health Sciences - Neonatal
Unit, Universita' degli Studi di Torino
(2). Department of Clinical Sciences and Community Health - Unit of
Medical Statistics & Biometry, Universita' degli Studi di Milano
Sir, we have read with great interest the paper by Cole et al. (1) on
the longitudinal growth in infants born below 32 weeks of gestation. It
raises a current and essential problem that neonatologists and
paediatricians take on daily: how to evaluate somatic growth in preterm-
born infants and children.
Cole et al. describe postnatal weight growth of preterm neonates,
analysing a very large number infants. They observe that the weight gain
of the mean growth curve peaks at about 16 g/kg/d at 32 weeks and falls to
about 8 g/kg/d at 42 weeks, i.e. about 4 and 14 weeks after birth, mean
gestational age at birth being 28.14 weeks (as can be derived from table 1
in their paper). We reported analogous results in a paper which described
the growth of 262 very low birth weight infants between birth and two
years of age (2). In particular, we also noticed that growth rate
presents an early peak (17.9 g/kg/d) at 3 weeks after birth, and falls to
10 g/kg/d at 14 weeks. These findings were based on a much lower number
of neonates (262, instead of 5009) selected according to a different
criterion of inclusion (birth weight below 1,500 g, instead of gestational
age below 32 weeks), and on a quite different approach to model individual
growth shape and trace median growth curve. This seems to confirm that
the peak in growth rate, observed in both studies a few weeks after birth
in preterm babies, is a fact, not an artifact due to the methods used to
analyze data.
We are grateful to Cole et al. for their important contribution which
clearly shows the pattern of postnatal growth in preterm neonates. We
hope that further studies may shed light on the biological mechanisms that
control postnatal weight gain in preterm and term babies.
1. Cole TJ, Statnikov Y, Santhakumaran S, Pan H, Modi N; on behalf of
the Neonatal Data Analysis Unit and the Preterm Growth Investigator Group.
Birth weight and longitudinal growth in infants born below 32 weeks'
gestation: a UK population study. Arch Dis Child Fetal Neonatal Ed. 2013,
Epub ahead of print.
2. Bertino E, Coscia A, Mombro' M, Boni L, Rossetti G, Fabris C, Spada E,
Milani S. Postnatal weight increase and growth velocity of very low
birthweight infants. Arch Dis Child Fetal Neonatal Ed. 2006, 91:F349-56
I read with great interest the commentary by John D. Lantos on the
SUPPORT study controversy. Dr. Lantos makes a compelling argument that the
OHRP was misguided in its criticism of SUPPORT, primarily because both
arms of the trial were within standard of care.1-2
Eligible infants whose parents refused to participate in SUPPORT
received the same medical care, but instead of randomization via protocol,
they were su...
I read with great interest the commentary by John D. Lantos on the
SUPPORT study controversy. Dr. Lantos makes a compelling argument that the
OHRP was misguided in its criticism of SUPPORT, primarily because both
arms of the trial were within standard of care.1-2
Eligible infants whose parents refused to participate in SUPPORT
received the same medical care, but instead of randomization via protocol,
they were subject to "idiosyncratic clinical judgments in the absence of
good evidence."1 That is a frightening concept. How can it be easier for a
physician to change clinical practice on a whim than it is for her to
study those very same differences in practice using the scientific method?
I agree that the informed consent process needs to change, but I
propose that we change the entire system. If both intervention arms of a
clinical trial are within standard practice, the IRB should not require
written informed consent at all. "In such situations," according to Dr.
Lantos, "there may be no incremental risk to being in a study. There may
even be some benefit." 1 Of course, these studies would continue to
require verbal assent from parents and prior approval from the IRB, but
shifting to an opt-out rather than an opt-in regime would significantly
benefit the progress of medicine. Indeed, some institutions outside of the
United States have already adopted this policy.3
No one wants to get rid of oversight for clinical research entirely,
but too much oversight has had a measurable and significant chilling
effect on scientific advancement.4 In my opinion, there is no doubt that
the obstacles to initiating and conducting clinical research would be more
navigable without the burden of universal written informed consent.
REFERENCES 1. Landtos JD. Learning the right lessons from the SUPPORT
study controversy. Arch Dis Child Fetal Neonatal Ed. 2013;epub ahead of
print. 2. SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal
Research Network. Target ranges of oxygen saturation in extremey preterm
infants. N Engl J Med. 2010;362:1959-1969. 3. Reignier J, Mercier E, Le
Gouge A, et al. Effect of not monitoring residual gastric volume on risk
of ventilator-associated pneumonia in adults receiving mechanical
ventilation and early enteral feeding: a randomized controlled trial.
JAMA. 2013;309:249-56 4. O'Herrin JK, Kudsk K, Frost N. Health insurance
portability Accountability Act (HIPAA) regulations: effect on medical
record research. Ann Surg. 2004;239:772-776.
Sirs
The tongue remains with in the boundaries of the mandible during suckling and so it is difficult to see the anatomical or the physiological basis for how a frenulectomy works in reducing breast and nipple discomfort during feeding. This randomised trial does not seem to assess the potential, positive psychological impact of the mother being told their child has had a frenulectomy. That is the question that...
Lawson's editorial and Emond and colleagues' article exposes potentially bad medicine: lack of knowledge of normal and variations of normal; lack of knowledge of the natural history of a condition; a desire to do something - Ulysses syndrome (1); medicalising the child by giving the condition a name; and then ascribing any improvement to the intervention, forgetting that association does not mean causation.
Th...
Dear Editors:
We read Val Finigan's letter with interest, and agree with her experience that most mothers do report an improvement in the comfort and efficacy of breastfeeding after their baby has had a frenotomy. The difficulty is in showing objective improvement in breastfeeding after division of less severe degrees of tongue tie.
In the Bristol Tongue Tie Trial, the median age of the babies at...
I am writing to express my concern regarding the discordance between the results and conclusions of this paper. The paper compares a point of care glucose measurement with a laboratory "gold standard". The results are presented in a number of forms (and with no consistency regarding units of measurement). The error-grid analysis is unhelpful as high levels will be high and low levels will be low for both methods and the scale...
Randomised controlled trial of early frenotomy in breastfed infants with mild-moderate tongue-tie. Edmond et al (2014)
Dear Editor, I read this report on frenotomy to support breastfeeding with great interest as currently there is limited evidence to support this procedure. The outcomes contrast considerably with my own experience and audit data, particularly with regard to persistence of breastfeeding for more...
Sirs, we were surprised to read that11 out of 56 units in the resource rich UK did not administer Rotavirus vaccine to their babies. (1) Thirty years ago, one of us described a neonatal rotavirus outbreak that had a considerable morbidity (2). Although these outbreaks continue(3.), some low resource units like ours (Birth rate 3000/year) are accredited as Breast Feeding Friendly and have adopted a very enthusiastic breast...
Sir, we thank Professor Bertino and his colleagues for their interest in our paper. We too were struck by the existence of a peak in relative weight velocity (g/kg/d) at 30-35 weeks postmenstrual age. It is striking that the timing of the peak is broadly the same irrespective of gestation - neonates born at 23 weeks take 10 weeks or so to reach peak velocity, whereas those born at 31 weeks reach their peak in only 2-3 wee...
At the end of this helpful review the Guideline is unclear, and potentially harmful, regarding Vitamin D supplementation. The phrase: "If no increase in phosphate levels and ALP continues to rise, consider" suggests that otherwise Vitamin D supplements should not be considered. The AAP guidance quoted, as well as clear guidance now in the UK from the Chief Medical Officers, the RCPCH and the British Paediatric and Adolesc...
Enrico Bertino (1), Silvano Milani (2), Elena Spada (2)
(1). Department of Public and Pediatric Health Sciences - Neonatal Unit, Universita' degli Studi di Torino (2). Department of Clinical Sciences and Community Health - Unit of Medical Statistics & Biometry, Universita' degli Studi di Milano
Sir, we have read with great interest the paper by Cole et al. (1) on the longitudinal growth in infants bo...
I read with great interest the commentary by John D. Lantos on the SUPPORT study controversy. Dr. Lantos makes a compelling argument that the OHRP was misguided in its criticism of SUPPORT, primarily because both arms of the trial were within standard of care.1-2
Eligible infants whose parents refused to participate in SUPPORT received the same medical care, but instead of randomization via protocol, they were su...
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