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T H H G Koh, Senior Specialist in Neonatology Kirwan Hospital for Women, Townsville, Great Barrier Reef, QLD 4817, AUSTRALIA.
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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 |
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Chris Harnden
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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. |
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Roger Wade
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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 |
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Diana R Elbourne, Senior Lecturer Medical Statistics Unit, London School of Hygiene and Tropical Medicine
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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 |
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Ramsay Glazener, Clinical Research Fellow Health Services Research Unit, University of Aberdeen, Campbell et al
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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. |
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Ramsay Glazener, Clinical Research Fellow Helath Services Research Unit, University of Aberdeen, Campbell et al
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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. |
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Rolf Lindemann, Consultant Neonatologist Dept. of Pediatrics, Ulleval Univ. Hospital, Oslo, Norway, Per Haga
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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. |
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R Lindemann
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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
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. |
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