Neonatal examination and screening trial (NEST): a randomised, controlled, switchback trial of alternative policies for low risk infantsCommentary: “Switchback” allocationdangerous bends ahead!
BMJ 1999; 318 doi: https://doi.org/10.1136/bmj.318.7184.627 (Published 06 March 1999) Cite this as: BMJ 1999;318:627All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Sir,
The paper by Glazener et al. concludes that one examination for the
newborn baby before discharge from the maternity ward would both be
clinical sufficient and economic1. The same question was raised in 1991 by
Moss et al.2 and thereafter commented by two letters3,4. Glazener et al.,
Moss et al and Hughes et al.1,2,4 did all agree on one examination, while
Manning3 strongly argued for a second examination, primarily not to miss
infants with congenital heart defects.
In Norway, as in many countries, two examinations have been
customary. The babies had their first examination within the first 24
hours and the second the day before discharge, usually the fourth day of
life. In 1987 we did a retrospective survey on newborn babies born at
Ullevaal University Hospital. Our question was; what did we pick up at the
second examination which was not diagnosed at the first?
During three months, we reviewed the medical records of 561 babies not
being admitted to the neonatal care unit. There was 102 remarks (18%) at
the first examination and additional 40 (7%) at the second. Of these,
31were of minor remarks, such as superficial infections, a mild jaundice,
cephal haematoma, among others. In nine babies (1,6%), additional remarks
were made at the second examination which should have been detected by the
first. Four (0,7%) had foot deformities which, however, only needed manual
distention by the mother. Two (0,35%) had a testis proximal in the
inguinal channel. The finding in these six babies (1,06%) were, however,
unimportant and needed no further control. Two babies (0,35%) had foot
deformities in such a character that they needed consultation by a
paediatric orthopaedic surgeon and they had their foot fixated. Our
impression is that the most of these findings would be noticed by
experienced midwives (or the mother) at least before discharge. The
neonatologist would then have been notified. The last baby had a positive
hip dislocation test (Ortolani), and was placed in a splint.
Since 1988 we have performed only one routine examination of the
newborn infants at the maternity ward. The examination is carried out the
second day of life. We found that to be a convenient day for several
reasons. At that time things have settled down after the birth, both for
the child and the mother. This makes it easier for the mother to take part
in the encounter constructively with questions and anxieties that have
cropped up.
The detection of congenital heart defects has been of major concern
when the need for two examinations has been discussed3. Congenital defects
produce heart murmurs when pressure differences cause blood flow velocity
of a certain magnitude. In all essence this means pressure differences
between the left and right side of the heart. The pulmonary vascular
pressure starts to fall after birth and in most babies will be lower on
the second day of life than on the first, making it more likely that
murmurs caused by congenital defects will be audible. In our study a
murmur was heard in two babies at the second examination that was not
heard at the first.
For the sake of diagnosing heart defects, an even later day than the
second would probably be preferable. This is, however, impractical both
because of early discharge as well as the other objectives behind the
examination.
Only one examination at discharge has also been suggested5. Nowadays,
many delivery departments tend to have an early discharge. Some infants
will then be examined the first day while others the fourth day or even
later after a caesarean section. Some of the findings will need a follow-
up, an ultrasound examination or a reference to another consultant,
leading to an additional day in the hospital. A disappointment for the
mother and the family.
Having an early discharge, these infants need follow-up for jaundice and
have to be screened for metabolic diseases. The experienced midwife will
register whether the infant has any abnormalities, has not gained in
weight, has an abnormal respiratory pattern or register if there are any
concerns from the parents. The neonatologist would then be notified and
perform a second examination on the infant.
Our experience for more than 10 years and approximately 30.000 deliveries
is that only one routine examination of the newborn baby performed the
second day of life will pick up nearly 100% of the abnormalities. This
routine is safe and efficient.
R Lindemann
P Hågå
Department of Paediatrics,
Ullevål University Hospital,
Oslo, Norway
1. Glazener CMA, Ramsay CR, Campell MK, Booth P, Duffty P, Lloyd DJ
et al. Neonatal
examination and screening trial (NEST): a randomised, controlled,
switchback trial of
alternative policies for low risk infants. BMJ 1999;318:627-32.
2. Moss GD, Cartlidge PHT, Speidel BD, Chambers TL. Routine examination in
the neonatal
period. BMJ 1991;302:878-9.
3. Manning DJ. One or two routine neonatal examinations? BMJ
1991;302:1209.
4. Hughes AP, Stoker AJ, Milligan DWA. One or two routine neonatal
examinations? BMJ
1991;302:1209.
5. Cartlidge PHT. Routine discharge examination of babies: is it
necessary? Arch Dis Child
1992;67:1421-2.
Competing interests: No competing interests
We agree that the term ‘undetected’, rather than 'missed' is correct
in the context of neonatal screening for developmental dysplasia of the
hip. Our data showed the vital importance of subsequent screening in the
community because of the lack of sensitivity of earlier examination.
Competing interests: No competing interests
Technically this study could be described as a cluster randomised
trial. However, for clustering to be of impact, management and hence
outcomes in relation to screening would have to be more similar within a
particular ward than across wards. Due to the practical administration of
screening within this study, we have no reason to believe this is the
case. Screening staff were not dedicated to specific wards, and visited
all the wards in turn. Wards did not specialise in particular categories
of babies (such as low- or high-risk), and further analysis did not reveal
any ward effects.
As Deeks stated, there was no reason to suspect non-random clustering
of cases within wards. Allocation bias could have arisen only if mothers
of high risk babies were systematically assigned to postnatal care on a
ward practising one of the policies. As this changed every month, and
assignation to a particular ward was done by consultant at the booking
clinic in early pregnancy, it is difficult to see how bias could occur.
Furthermore, if we had randomised by individual baby, mothers in
adjacent beds would have had different policies, which would have caused
confusion in maintaining treatment allocation.
Competing interests: No competing interests
Dear Sir
Analysis by individual or by cluster?
The trial reported by Glazener and colleagues (1) is of interest not
only for its substantive content but also on methodological grounds. The
Commentary by Deeks (2) alludes to a particular issue, that of the unit of
randomisation. Neonates were not randomised individually but in clusters
(wards). Yet the analysis ignores any potential clustering effect. Why
did the authors choose this approach? Adjusting for clustering is often
complicated and may lead to a loss of power. It would therefore be
helpful if the authors would explain whether there is a simple way of
being able to identify situations in which cluster randomised trials can
be analysed as if they were individually randomised trials without
jeopardising their validity. This would have implications for others
undertaking such trials in the future.
Yours sincerely
Diana Elbourne
(1) Glazener C, Ramsay C, Campbell MK, Booth P, Duffty P, Lloyd D,
McDonald A, Reid A. Neonatal Examination and Screening Trial (NEST): a
randomised controlled switchback trial of alternative polices of low risk
infants. BMJ 1999; 318: 627-631
(2) Deeks J. Commentary: "Switchback" allocation - dangerous bends ahead!
BMJ 1999; 318: 631-2
Competing interests: No competing interests
EDITOR - Glazener et al1 state that in congenital displacement of the
hip evaluated by neonatal screening that the 70% which required surgery
were 'missed' by routine screening. Jones et al 2 has shown that the
Ortolani test is very specific (>90%) but not sensitive (<60%). The
test therefore fails the criteria for a successful screening test 3. It
is accepted that 'congenital displacement of the hip' maybe early or late.
This has resulted in a change of the term CDH (congenital dislocation of
the hip) to DDH (developmental dysplasia of the hip). Late presentation
with dislocation of the hip (presenting at greater than 6 months) canbe
stable at birth. The use of 'missed' should be discouraged as it suggests
negligence in the neonatal assessment. In fact the hip may have been
irreducible at birth or stable but dysplastic; both conditions which would
result in a negative Ortolani test.
Roger Wade
Specialist registrar in Orthopaedics
Sanjeev Jari
Specialist registrar in Orthopaedics
Robin Paton
Consultant Orthopaedic Surgeon
Department of Orthopaedics
Blackburn Royal Infirmary
Blackburn
Lancashire BB2 3LR
1 Glazener CM, Ramsey CR, Campbell MK, Duffty P, Lloyd DJ, McDonald
A, Reid JA. Neonatal examination and screening trial (NEST): a
randomised, controlled, switchback trial of alternative policies for low
risk infants. BMJ 1999;318: 627-31 (6 March)
2 Jones DA. Neonatal detection of developmental dysplasia of the hip
(DDH). J Bone Joint Surg. [Br], 1998;80-B:943-5.
3 Lancet: Editorial, Screening for congenital hip dysplasia. Lancet
1991;337:947-8
Competing interests: No competing interests
Editor- The article by Glazener (1), defines neonatal screening in
very narrow medical terms. The second neonatal examination is usually
performed in a primary care setting by a general practitioner. The main
purpose of this examination is not just to screen for medical conditions
such as hip and heart disease. the examination also provides an excellent
oppurtunity to screen for postnatal depression, the incidence of which can
be 11% using the Edinburgh depression rating score (2). The examination
also provides an insight into the interaction between a mother and her
baby, as well as providing an opportunity to advise about vaccinations,
cot death prevention and accident prevention.
Chris Harnden
General practitioner
Prescott Surgery
Baschurch
Shropshire SY4 2DR
1 Glazener CMA, Ramsay C R, Campbell M K, Booth P, Duffy P, Lloyd D,
McDonald A, Reid J A. Neonatal examination and screening trial: a
randomised, controlled and switchback trial of alternative policies for
low risk infants.
2 Lane A, Kelville R, Morris M, Kinsella A, Turner M, Barry S.
Postnatal depression and elation amongst mothers and their partners:
prevalence and predictors.
Competing interests: No competing interests
al (6.3.99) with interest. They described a study of two or one neonatal
examinations done by medical staff. In our hospital all newborn babies are
examined soon after birth by the midwife for gross anomalies which include
cleft palate, spinal deformities, skull and facial deformity, limbs
anormalities such as syndactyly, number of vessels in umbilical cord. The
abnormalities are recorded on the back page of the mother's partogram and
the doctor notified. Indeed I was just now requested to see a baby born
last night; the attending midwife noted a tooth in the
baby lower gum when she examined the baby after birth. I remember this was
the practice during my 10 years of service in NHS hospitals in England and
would think that it is still so today. If that is so the babies in the
study would have been examined three times instead of twice and twice
instead of once. It would be useful to know
how many of the gross superficial abnormailities in the Aberdeen study
were detected soon after birth by the midwives.
yours sincerely,
Koh T.H.H.G.
Senior Specialist in Neonatology,
Kirwan Hospital for Women,
Townsville, Great Barrier Reef, QLD 4817, Australia
competing interest: nil
Competing interests: No competing interests
Should the newborn baby have one or two routine examinations?
Sir
The paper by Glazener et al. concludes that one examination for the
newborn baby before discharge from the maternity ward would both be
clinical sufficient and economic.[1] The same question was raised in 1991
by Moss et al.[2] and thereafter commented on in two letters.[3] [4]
Glazener et al. Moss et al and Hughes et al.[1] [2] [4] did all agree on
one examination, while Manning[3] strongly argued for a second
examination, primarily not to miss infants with congenital heart defects.
In Norway, as in many countries, two examinations have been
customary. The babies had their first examination within the first 24
hours and the second on the day before discharge, usually the fourth day
of life. In 1987 we did a retrospective survey on newborn babies born at
Ullevål University Hospital. Our question was; what did we pick up at the
second examination that was not diagnosed at the first?
During three months, we reviewed the medical records of 561 babies
not being admitted to the neonatal care unit. There were 102 remarks made
(18 %) at the first examination and additional 40 (7 %) at the second. Of
these, 31 were minor, such as superficial infections, mild jaundice,
cephalhaematoma, among others. In nine babies (1.6 %), additional remarks
were made at the second examination which should have been detected at the
first. Four (0.7 %) had foot deformities which, however, only needed
manual distention by the mother. Two (0.4 %) had a testis proximal in the
inguinal channel. The finding in these six babies (1.1 %) were, thus,
unimportant and needed no further control. Two babies (0.4 %) had foot
deformities of such a character that they needed evaluation by a
paediatric orthopaedic surgeon and each had their foot fixated. Our
impression is that the most of these findings would have been noticed by
experienced midwives (or the mother) at least before discharge. The
neonatologist would then have been notified. The last baby had a positive
hip dislocation test (Ortolani), and was placed in a splint.
Since 1988 we have performed only one routine examination of the
newborn infants at the maternity ward. The examination is carried out the
second day of life. We found that to be a convenient day for several
reasons. At that time things have settled down after the birth, both for
the child and the mother. This makes it easier for the mother to take part
in the encounter constructively with questions and voice anxieties that
have cropped up.
The detection of congenital heart defects has been of major concern
when the need for two examinations has been discussed.[3] Congenital
defects produce heart murmurs when pressure differences cause blood flow
velocity of a certain magnitude. Apart from stenoses, in the majority of
cases this means pressure differences between the left and right side of
the heart. The pulmonary vascular pressure starts to fall after birth and
in most babies will be lower on the second day of life than on the first,
making it more likely that murmurs caused by congenital defects will be
audible on the second day. In our study a murmur was heard in two babies
at the second examination that was not heard at the first.
For the sake of diagnosing heart defects, an even later day than the
second would probably be preferable. This is, however, impractical both
because of early discharge as well as the other objectives behind the
examination.
Only one examination at discharge has also been suggested.[5]
Nowadays, many delivery departments tend to have an early discharge. Some
infants will then be examined the first day while others the fourth day or
even later after a caesarean section. Some findings will necessitate a
follow-up, an ultrasound examination or a referal to another consultant.
This may lead to an additional day in hospital. A disappointment for the
mother and the family.
Early discharge necessitates follow-up for jaundice and screening for
metabolic diseases. The experienced midwife will register whether the
infant has any abnormalities, has not gained in weight, has an abnormal
respiratory pattern and register if the parents have any concerns. The
neonatologist will then be notified and perform a second examination of
the infant.
Our experience for more than 10 years and approximately 30.000
deliveries is that only one routine examination of the newborn baby
performed the second day of life will pick up nearly 100% of the
abnormalities. This routine is safe and efficient.
R Lindemann
P Hågå
Department of Paediatrics,
Ullevål University Hospital,
Oslo, Norway
1 Glazener CMA, Ramsay CR, Campell MK, Booth P, Duffty P, Lloyd DJ
et al. Neonatal examination and screening trial (NEST): a randomised,
controlled, switchback trial of alternative policies for low risk infants.
BMJ 1999;318:627-32.
2 Moss GD, Cartlidge PHT, Speidel BD, Chambers TL. Routine examination in
the neonatal period. BMJ 1991;302:878-9.
3 Manning DJ. One or two routine neonatal examinations? BMJ
1991;302:1209.
4 Hughes AP, Stoker AJ, Milligan DWA. One or two routine neonatal
examinations? BMJ 1991;302:1209.
5 Cartlidge PHT. Routine discharge examination of babies: is it
necessary? Arch Dis Child 1992;67:1421-2.
Competing interests: No competing interests