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Legislation American trials which were being Arch Dis Child: first published as 10.1136/adc.2004.064378 on 20 May 2005. Downloaded from ...... submitted to the Food and Drug Administration (FDA)). An additional development in Europe Should paediatricians support the is that all new clinical trials involving medicines need to be registered with the European Paediatric Clinical Trials EMEA. This legislation affects both the pharmaceutical industry and academic Register? investigators who carry out independent research. What is not known at this H M Sammons, C Naylor, I Choonara, C Pandolfini, M Bonati stage is how much of the information available on the European Clinical Trials ...... Register will be accessible to academia, health professionals, and the public. A Ensuring its success will help improve the use of medicines register that is only accessible to the in children regulatory authorities will not benefit children. he importance of clinical trials in receive the safest and most effective children in providing a scientific treatment, health professionals need the DO PAEDIATRIC CLINICAL TRIALS Tevidence base for drug therapy is complete information. The existence of NEED A SEPARATE REGISTER? accepted by health professionals, regu- the European Paediatric Clinical Trials Health professionals who work with latory authorities, the pharmaceutical Register does not ensure publication.6 It children are well aware that many industry, and the parents of children. does, however, alert health professionals medicines used in paediatric patients Legislation in the USA alongside gov- to the fact that a clinical trial has been are either unlicensed or used off label.11 ernment investment in research has completed. This then allows researchers It is well recognised that drug toxicity in resulted in a significant increase in who are carrying out systematic reviews children is different to that in adults.12 paediatric clinical trials in North to contact the investigators directly and Additionally, the design of paediatric America.1 European legislation is cur- obtain unpublished data. The existence clinical trials is different to that in rently being proposed that will provide a of a register also prevents duplication by adults, where healthy volunteers can financial incentive to the pharmaceuti- investigators and encourages collabora- be used.13 Recruitment to paediatric cal industry to study medicines in tion. Additionally, it allows sponsors clinical trials involves patients and there- Europe. The proposal has been prepared (medical charities, Department of fore is usually slower, requiring more by the European Commission following Health) to ensure that duplicate studies emphasis on safety than corresponding extensive consultation. Within the UK are not funded. studies in adults.14 For these reasons, the establishment of a Medicines for there is a clear need for a separate register Children Research Network will hope- Pharmaceutical industry of paediatric clinical trials. fully also ensure that more clinical trials Concern has been raised that clinical are performed in paediatric patients of trials which produce negative results are EUROPEAN PAEDIATRIC CLINICAL all ages. deliberately suppressed by the pharma- TRIALS REGISTER http://adc.bmj.com/ ceutical industry.78 In the UK, the There is currently only one clinical trials REGISTRATION OF CLINICAL Association of the British Pharma- register that exclusively deals with TRIALS ceutical Industry (ABPI) has established paediatric clinical trials. This register There is increasing recognition that as a Clinical Trial Register. This register, was established with funding from the well as performing clinical trials, regis- however, is only voluntary and not all European Community.6 The project tration is essential.23 Many completed companies are supporting it. It is only commenced in January 2003 and cur- clinical trials are never published. A public pressure or legislation that will rently involves four countries: Italy, on September 27, 2021 by guest. Protected copyright. group of researchers in North America ensure that the pharmaceutical industry France, Spain, and the UK. The lead have studied the publication of clinical fully supports the concept of registration centre is in Milan and the register went trials that had been presented as of clinical trials. live on 1 July 2004.15 It can be accessed abstracts at the Society for Pediatric through the website www.dec-net.org. Research. They found that 28% of Compulsory registration The register is freely available to both abstracts were subsequently not pub- Several leading adult medical journals health professionals and the public. lished.4 This however may have been an have declared that clinical trials sub- Trial information is available in two underestimate as they relied on the mitted for publication will need to have different formats, a simple one aimed at return of questionnaires from authors been registered in order for their find- parents and the public and a more who had presented the abstracts. A ings to be published.910 This is a advanced one aimed at health profes- British study of the publication rate welcome step and will ensure that sionals. Users are, however, free to following presentation at two national clinical trials registers are used. The choose whether they obtain the simple meetings found that 22% and 49% of the International Committee of Medical or advanced information. Information presentations were subsequently not Journal Editors (ICMJE) has not advo- listed in the register is as follows: published as full papers.5 In the majority cated a particular register but has of cases the authors did not submit their suggested that the register sponsored N Title of protocol findings for publication. by the United States National Library of N Status of the clinical trial The lack of publication of completed Medicine (www.clinicaltrials.gov) meets N Disease 9 clinical trials adversely affects the evi- all their necessary requirements. N Age and sex of patients being studied dence base on which decisions regard- Concerns have, however, been expressed ing choice of drugs and dosage in in that this register is quite restrictive as N Aim of the study relation to efficacy and toxicity are to which trials can be registered10 (the N Contact details for lead investigator made. In order to ensure that children register was primarily designed for N Participating centres/countries.

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The advanced view contains more Within the UK there has been con- opportunity. Paed Perinat Drug Ther Arch Dis Child: first published as 10.1136/adc.2004.064378 on 20 May 2005. Downloaded from 2000;4:71–4. details and includes administrative siderable support for the register from 2 Dickersin K, Rennie D. Registering clinical trials. information about the trial (local pro- the Royal College of Paediatrics and JAMA 2003;290:516–22. tocol number, EUDRACT number, Child Health, the Neonatal and 3 Steinbrook R. Public registration of clinical trials. N Engl J Med 2004;351:315–17. ISRCTN number). Also included are Paediatric Pharmacists Group, and the 4 Hartling L, Craig WR, Russell K, et al. Factors the following: ABPI. Over 40 of the clinical trials on the influencing the publication of randomized register are studies from the UK. More controlled trials in child health research. Arch Pediatr Adolesc Med 2004;158:983–7. N Name of the drug than 20 different academic units and 5 Riordan FAI. Do presenters to paediatric meetings N Type of trial (therapeutic efficacy, NHS hospitals have already provided get their work published? Arch Dis Child information on clinical trials that they 2000;83:524–6. pharmacokinetic, safety/toxicity) 6 Pandolfini C, Bonati M, Sammons H, et al. A are involved in. Ensuring the success of N Inclusion criteria European clinical trials registry for children. Paed the only Paediatric Clinical Trials Perinat Drug Ther 2003;5:98–100. N Exclusion criteria. Register worldwide will help improve 7 Herxheimer A, Mintzes B. Antidepressants and adverse effects in young patients: uncovering the the use of medicines in children. evidence. CMAJ 2004;170:487–9. Since the official launch of the register, Arch Dis Child 2005;90:559–560. 8 Whittington CJ, Kendall T, Fonagy P, et al. the website has seen an average of 400– Selective serotonin reuptake inhibitors in doi: 10.1136/adc.2004.062836 500 hits each month. As of January childhood depression: systematic review of published versus unpublished data. Lancet 2005 the website had had over 3700 ...... 2004;363:1341–5. visits. This illustrates the importance of Authors’ affiliations 9 De Angelis C, Drazen JM, Frizelle FA, et al. ensuring that the website is user Clinical trial registration: a statement from the H M Sammons, C Naylor, I Choonara, International Committee of Medical Journal friendly. Academic Division of Child Health, The Editors. N Engl J Med 2004;351:1250–1. The register currently contains details Medical School, University of Nottingham, 10 Abbasi K. Compulsory registration of clinical of over 60 clinical trials. These range Derbyshire Children’s Hospital, Derby, UK trials. BMJ 2004;329:637–8. 11 Turner S, Longworth A, Nunn AJ, et al. from double blind randomised con- C Pandolfini, M Bonati, Mario Negri Institute, Unlicensed drug use on paediatric wards. BMJ trolled trials to pilot studies and open Milan, Italy 1998;316:343–5. observational studies. A wide range of 12 Choonara I, Rieder MJ. Drug toxicity and adverse drug reactions in children—a brief clinical conditions are covered, several Correspondence to: Prof. I Choonara, historical review. Paed Perinat Drug Ther of which involve analgesia following Academic Division of Child Health, The Medical 2002;5:12–18. School, University of Nottingham, Derbyshire surgery, the treatment of asthma, gastro- 13 Keinonen T, Miettinen P, Saano V, et al. Clinical Children’s Hospital, Uttoxeter Road, Derby trials in children and healthy volunteers. Quality oesophageal reflux, attention deficit DE22 3DT, UK; imti.choonara@nottingham. and characteristics of notifications reviewed by hyperactivity disorder, HIV, and dia- ac.uk the regulatory agency in Finland. Paed Perinat betes mellitus. The status of the vast Drug Ther 2003;5:175–82. Competing interests: none declared 14 Peden V, Choonara I, Gennery B, et al. Recruiting majority of these trials is that they are children to a clinical trial. Paed Perinat Drug Ther currently recruiting patients and in REFERENCES 2000;4:75–8. 15 Bonati M, Pandolfini C, Rossi V, et al. Launch of a only a few cases have the clinical trials 1 Spielberg SP. Paediatric therapeutics in the European paediatric clinical trials register. Paed been completed. USA and internationally: an unparalleled Perinat Drug Ther 2004;6:38–9. http://adc.bmj.com/

Obstetrics . Gobind , the last ...... guru, decreed that after his death in the form of the religious book called the , Sikh birth customs should be followed and command the same respect and authority as a human on September 27, 2021 by guest. Protected copyright. R Gatrad, J Jhutti-Johal, P S Gill, A Sheikh guru. is a monotheistic religion ...... and the ultimate goal of is to An overview of Sikh and its impact on perinatal practice achieve liberation (Mukti or Moksha) from the cycle of birth, death, and re- birth and eventually be one with the his is the third in a series of Sikhism is the fourth commonest reli- Divine, depending on the outcome of occasional articles on birth customs gion, there are over 336 000 Sikhs. The their (deeds). Tamong the major non-Christian largest Sikh conurbations are in Sikhs can essentially be divided into in the UK. Reviews on birth Southall in west London and the West two main groups: the baptised and the 3 customs among Muslims and Hindus Midlands. non-baptised. The Pahul or 12 have already been published. Here we ceremony () is undertaken provide an overview of the basic tenets KEY BELIEFS when an individual fully comprehends of Sikh theology and its impact on The word ‘‘Sikh’’ is derived from the implications of such an act. Hence, it perinatal practice. a Sanskrit word ‘‘shisya’’ meaning a is rare for a pre-pubescent child to be ‘‘learner’’ or a ‘‘disciple’’. Sikhism was baptised. There is no upper age limit to DEMOGRAPHY founded by in the 15th baptism, which is encouraged for both Although the largest Sikh communities century against a backdrop of Hindu/ men and women. The ceremony takes are to be found in the in Muslim conflict.4 There then followed place in the presence of the Guru Granth Northern India, Sikhs are now scattered nine further who promoted inclu- Sahib. Here the principles of Sikh around the globe, including Europe and siveness and union with for all, and other key instructions on how a North America. In the UK, where irrespective of gender, caste, race, or baptised Sikh must live are imparted to

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identity—the so-called ‘‘five Ks’’ (see still considered taboo by most Sikhs. Arch Dis Child: first published as 10.1136/adc.2004.064378 on 20 May 2005. Downloaded from box 1). Expectant mothers are encouraged dur- Baptised Sikhs (Amrit-dhari or ) ing pregnancy to keep to a healthy diet constitute an ‘‘’’ within to nourish the unborn child Sikhism. Non-baptised Sikhs (who form A child is seen as a gift from God and the majority in the UK) are either Kes- therefore should be nurtured from con- dhari Sikhs (keep their hair unshorn and ception. A baptised Sikh woman will wear the outward symbols of the Sikh refrain from eating meat and eggs, faith), or Mona Sikhs (retain an affilia- which may result in iron deficiency, tion to the Khalsa but remove the out- requiring regular monitoring, with ward symbols of the faith). This advice on alternative sources of iron. information can be useful for health professionals at various points of con- Abortion tact during antenatal and postnatal care There is no specific dictate in religious (see below). texts about therapeutic abortions. Many Sikhs will therefore interpret certain PREGNANCY AND CHILDBIRTH parts of texts and make a personal Guru Nanak advocated a monogamous decision when confronted with a clearly relationship that was not consangui- abnormal fetus. Generally, as Sikhs neous. Every Sikh child is believed to believe that the soul is ‘‘born’’ immedi- contain a ‘‘divine spark’’ of the creator. ately on conception, abortion is not Figure 1 , the Sikh symbol, is made up For a Sikh, the point at which a baby is accepted. However, if the mother’s life of two swords, a symbol of fighting for what is conceived represents the soul’s entry is threatened by the continuation of right. Between them is a circle, depicting that into the world. Conception is therefore God is one—without beginning or end. pregnancy then termination is often a sacred act, carried out within the acceptable. confines of a marriage that has been the initiate. These include devotion to blessed in front of the Guru Granth Childbirth God; service to mankind; fighting Sahib. Sikhism does not prescribe any special against injustice; and defence of the during labour. All family mem- weak. These religious virtues are repre- ‘‘In the mothers womb, life was bers will be encouraged to meditate and sented by the religious Sikh symbol enshrined and cherished. You were say for the newborn and the known as the Khanda (fig 1). blessed with body and soul.’’ (Guru mother. The mother herself will try and On acceptance of these instructions, Arjan, Guru Granth Sahib, p. 1004) meditate during labour and also recall five handfuls of Amrit (nectar of immor- verses from the Guru Granth Sahib. As tality—prepared by pouring and is the case with women in general, out sugar pellets into a steel bowl and Family planning of a sense of modesty, many Sikh stirring the mixture with a double edged This is left very much to the couple. mothers-to-be would prefer to be seen dagger while selected verses from the There are no injunctions in Sikhism by female health professionals during Guru Granth Sahib are read out aloud) against the use of contraceptives within pregnancy and labour. In the case of http://adc.bmj.com/ are drunk by the initiate and five a married relationship and no insistence baptised Sikh women, are handfuls are sprinkled over their hair on abstinence. worn at all times and the mother should and eyes. If a person does not have a be consulted before removing any of Sikh name, they now take one. The Sex determination these items. A request for keeping the person is thus formally admitted to the Some Sikhs are now participating in the Kachha (underwear) on one leg may be Khalsa (baptised) community.5 It now growing practice of gender selection, made. Shaving of the perineum may not becomes obligatory for such a person to be acceptable to the patient and if it is

particularly in the hope of having a on September 27, 2021 by guest. Protected copyright. wear the outward symbols of Sikh male child. Most South Asian cultures clinically necessary a very sensitive have traditionally valued a male child approach is advised. more than female because of the eco- nomic benefit and continuation of the Postnatal considerations Box 1: External symbols worn family line.6 The gurus tried to reverse After labour, the mother is encouraged by Sikhs—the ‘‘five Ks’’ and halt this trend by giving women a to rest and recuperate. This is a cultural special status as described in the Guru practice and not religious. Mothers N Kes—uncut hair to preserve Granth Sahib.5 However, a strong desire should therefore be advised on early God-given human form to have a male child still continues ambulation to prevent venous thrombo- N —comb to keep hair today. From the religious viewpoint, sis. There is no concept of ‘‘pollution’’ (a tidy and symbolises discipline the sex of a child is pre-ordained and state of being ‘‘unclean’’ as a result of any interference should therefore be vaginal discharge, precluding women and clarity of mind discouraged. from household chores) surrounding N —a sword which symbo- the mother either before, during, or lises freedom and justice Diet, smoking, and alcohol after childbirth (in contrast to some N —iron/steel bracelet worn All Sikhs, whether baptised or not are other South Asian , such as on right hand, reminding the instructed to refrain from taking any ).7 wearer of God’s strength and form of intoxicant (smoking, drugs, A few days after birth the immediate alcohol, etc). However, in practice, family will go to the to infinity although drinking alcohol is quite com- present the baby to the Guru Granth N Kachha—short breeches empha- mon among the non-baptised, particu- Sahib and recite hymns that are expres- sising commitment to purity larly men, this is rare among women. sive of joy and thankfulness. Karhah Smoking is much less common and is Prashad (sacred pudding) is also eaten.

www.archdischild.com 562 LEADING ARTICLE Arch Dis Child: first published as 10.1136/adc.2004.064378 on 20 May 2005. Downloaded from Growth of Sikh babies Table 1 Examples of mother, as a blessing and for its A study by one of the authors, com- with their meanings ‘‘cleansing’’ properties, also drinks paring preschool heights and weight some. Many Sikh babies are given a of Europeans with five South Asian Name Meaning Kara (bangle), often on the thir- subgroups (Sikhs, Hindus, Muslim teenth day, but there is no time Amarjit Forever victorious Pakistanis, Muslim Bangladeshis, and Balraj Mighty king constraint on when it is given, and Muslim Gujaratis) in the West Baljit Mighty victorious the paternal or maternal immediate Midlands, showed that Sikh boys and Mandeep Light of sages family may give it. girls were significantly heavier than the Manjit The one who controls the mind N Glass of water or something metallic other South Asian subgroups at birth; Ranjit Conqueror of the battle under a baby’s cot. Both of these this pattern continued until at least the Suchdev God of peace customs are rooted in Indian tradi- 8 age of 5 years. In addition, both Sikh Sukhraj King of peace tion. Because of their upbringing in males and females at birth were the India, older Sikhs may follow these tallest of all the Asian subgroups and customs which may then be passed were also taller than European babies; onto subsequent generations. this pattern again continued up to at Without such rituals, some families least the age of 5 years. the UK. Thus Baljit Singh Khera would feelthebabyisvulnerablefrom Growth is determined by genetic, be a male. ‘‘evil’’ spirits. nutritional, and other environmental factors. These variations could, it was N Home visits after birth. Some families in Breast feeding and weaning speculated, be explained by the fact that the UK are still superstitious and will Breast feeding is positively encouraged Sikhs are the most affluent South Asian not allow visitors to enter the house within the Sikh faith as it is considered group in Walsall (West Midlands), and directly visit the new baby and a completely natural process and the resulting possibly in a more wholesome mother. They are often initially led to best nourishment for the infant. The diet for the mother and baby. another room to ‘‘shake off’’ evil duration of breast feeding and the Future research in this area could be spirits. timing of weaning the child is entirely directed, not only to repeating this N Fasting. This does not have any a personal choice and not dictated by relatively old study, but also to ascertain religious significance or merit within religious teaching. growth patterns beyond the age of Sikh theology. Some women may fast There are however certain customs 5 years. during pregnancy for the wellbeing that may be carried out by some Sikh of their husbands as they are the women which may have clinical ramifi- providers of the family. This custom Naming customs cations. For example, a mother may is ‘‘borrowed’’ from Hinduism. The Many Sikhs will name their baby on the return to her maternal home for 40 days possible risks of fasting to the unborn fortieth day after birth in a simple child after the birth of the baby, which may child should be highlighted to the naming ceremony (Nam Karan). A result in missing of postnatal appoint- expectant mother. (Ardas) is recited. The Guru ments. However, these practices are Granth Sahib is then opened at random rooted in culture and social tradition, and the first letter from the top of the often borrowed from other religions left page is used as the first letter of the such as Hinduism, rather than Sikh Postmortem examinations and http://adc.bmj.com/ name of the child. Either the parents theology, and can vary markedly from organ transplantation announce the name of the child imme- family to family. As with people from any cultural or diately, or later after consulting other We have encountered some other religious background, this issue should members of the family. Sikh parents practices of individuals/families which be broached sensitively. There is no may choose a name without this cere- have no sound theological basis in the prohibition with respect to either post- mony, and yet others will get the Sikh religion, including: mortem examinations or organ trans- paternal aunt or another close relative plants, as Sikhs fundamentally believe on September 27, 2021 by guest. Protected copyright. to choose, a process which may result in N in ‘‘hot’’ and ‘‘cold’’ foods. Certain that the body is simply just a shell to delay in registering the infant’s name. foods are believed to have a ‘‘cooling’’ transport the soul while it resides on its Further, to emphasise the equality of or ‘‘heating’’ effect on the function of earthly sojourn. Death marks the release human beings and in explicit rejection various organs of the body. This of the ‘‘knot’’ between body and soul. of the Hindu caste system,5 all men and concept is divorced from the actual When a child is miscarried, depending women who joined the Khalsa add the temperature of food or even how on the developmental stage of the name Singh (meaning ‘‘lion’’) to the spicy the food is. ‘‘Hot’’ foods such embryo, no ceremony is usually con- forename of a son, and Kaur (meaning as lentils, aubergines, and eggs are ducted. The parents will be encouraged ‘‘princess’’) for girls. All Sikh names thoughttoincreasephysicaland to pray and meditate for the soul. If a have a special religious meaning; for emotional activity, and ‘‘cold’’ foods formed fetus dies in the womb and is example, Baljit means ‘‘mighty victor- such as milk, white sugar, fruits, and delivered, then a ceremony may be ious’’. It is of practical interest to note cereals have a calming effect. This conducted. that these names are not gender speci- concept has particular relevance dur- For a stillborn child or one who dies fic; for example, as shown in table 1, ing pregnancy. For example, bleeding shortly after birth, most parents will Baljit Singh is a boy and Baljit Kaur is a of pregnancy may be attributed to want their baby to be cremated. This girl. Some families use caste/surnames; ‘‘hot’’ foods and therefore these are ceremony is usually for the immediate for example, in the above case Baljit avoided; conversely the same foods family only and culminates in the Khera instead of Baljit Singh. This could are encouraged during the postpar- scattering of ashes into a river or sea. therefore lead to gender confusion and tum period and breast feeding. Sometimes this involves a trip to India could possibly be avoided by the use of N Role of Amrit—. Some families where ashes of previous family mem- Singh or Kaur as the middle name, as insert a few drops of this especially bers were disposed. This custom of many non-baptised Sikhs continue to prepared sweetened water into the scattering ashes in flowing rivers is use their caste/surname, particularly in mouth of the baby, while the practised as it precludes erection of

www.archdischild.com LEADING ARTICLE 563 Arch Dis Child: first published as 10.1136/adc.2004.064378 on 20 May 2005. Downloaded from gravestones—a practice forbidden by ...... REFERENCES the Sikh religion. Authors’ affiliations 1 Gatrad AR, Sheikh A. Muslim birth customs. Arch R Gatrad, Manor Hospital, Walsall, UK Dis Child Fetal Neonatal Ed 2001;84:F6–8. J Jhutti-Johal, Department of Theology, 2 Gatrad AR, Ray M, Sheikh A. Hindu birth CONCLUSIONS University of Birmingham, UK customs. Arch Dis Child 2004;89:1094–7. P S Gill, Department of Primary Care and 3 www.statistics.gov.uk/CCI/nugget.asp? Since beliefs may vary among Sikhs, it is ID = 293&Pos = 6&ColRank = 1&Rank = 3 General Practice, University of Birmingham, important to ask rather than assume (accessed 27 June 2004). UK 4 Keay J. A history of India. London: HarperCollins, what is important to the individual/ A Sheikh, Division of Community Health 2000. family. This is particularly so as there Sciences: GP Section, University of Edinburgh, 5 www.allaboutsikhs.com (accessed 27 June 2004). are generally no elaborate rituals or Edinburgh, UK 6 Jhutti J. Dowry among Sikhs in Britain. In: Menski W, ed. South Asian and the dowry ceremonies, compared to other South problem. Stoke on Trent: Trentham Books, 1998. Asian religions, surrounding childbirth Correspondence to: Dr P S Gill, Department of 7 Singh NGK. The feminine principle in the Sikh within the Sikh faith. Primary Care and General Practice, University vision of the transcendent. Cambridge: of Birmingham, Birmingham B15 2TT, UK; Cambridge University Press, 1993. [email protected] 8 Gatrad A, Birch N, Hughes M. Pre-school weights Arch Dis Child 2005;90:560–563. and heights of European and five sub-groups of Asians in Britain. Arch Dis Child doi: 10.1136/adc.2004.064378 Competing interests: none declared 1994;71:207–10.

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