1、BSI Standards PublicationEarly care services for babies born with cleft lip and/or palatePD CEN/TR 16824:2015National forewordThis Published Document is the UK implementation of CEN/TR 16824:2015.The UK participation in its preparation was entrusted by TechnicalCommittee CH/100, Healthcare and medic
2、al equipment (European andInternational), to Panel CH/100/-/3, Care Services for Cleft Lip and/or Palate.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are
3、responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 86875 7ICS 11.020Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStand
4、ards Policy and Strategy Committee on 31 March 2015.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN/TR 16824:2015TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN/TR 16824 March 2015 ICS 11.020 English Version Early care services for babies born with
5、 cleft lip and/or palate Services de prise en charge prcoce des bbs ns avec une fente labiale et/ou palatine Frsorgedienstleistungen fr Babies mit Lippen-, Kiefer-und Gaumenspalten This Technical Report was approved by CEN on 7 March 2015. It has been drawn up by the Technical Committee CEN/TC 424.
6、CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland
7、, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in
8、 any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN/TR 16824:2015 ECEN/TR 16824:2015 (E) 2 Contents Page Foreword 4 Introduction .5 1 Scope 6 2 Terms and definitions .6 3 Diagnosis and referrals .7 3.1 Antenatal diagnosis .7 3.1.1 Recommendations on making the diagno
9、sis .7 3.1.2 Limitation of ultrasound 7 3.1.3 Suspected cleft lip and/or palate 7 3.1.4 Recommendations on referral to the cleft team .8 3.2 Postnatal diagnosis .8 3.2.1 Recommendations on making the diagnosis .8 3.2.2 Recommendations on referrals 9 4 Immediate Postnatal Care .9 4.1 Clinical assessm
10、ent 9 4.1.1 General 9 4.1.2 Pierre Robin Sequence managing airway obstruction 10 4.2 Early parental involvement 10 5 Feeding 10 5.1 Knowledge and skills of person providing feeding advice 10 5.2 Clinical assessment . 10 5.3 Feeding plan 11 5.4 Growth Measures 11 6 Monitoring the baby and preparation
11、 for surgery . 12 6.1 Monitoring . 12 6.2 Preparation for Surgery . 12 7 Recommendations for involving and supporting parents . 12 7.1 Involving parents 12 7.2 Parent to parent support 13 8 The longer term care pathway . 13 8.1 Scope of a care pathway 13 8.2 Long term care pathway 14 9 Recommendatio
12、ns for the cleft unit team members and facility requirements . 16 9.1 Team members 16 9.2 Education and training . 16 9.3 Team management and responsibilities 16 9.3.1 Communication and coordination 16 9.3.2 Referral and communication with other professionals 16 9.3.3 Research 16 10 Recommendations
13、for organization of the cleft service, including clinical governance and audit . 16 10.1 Service requirement . 16 10.2 Facilities for parents and children 17 10.2.1 Out-patient medical and dental care . 17 PD CEN/TR 16824:2015CEN/TR 16824:2015 (E) 3 10.2.2 In-patient care 17 10.3 Clinical governance
14、 . 17 10.4 High quality standards 17 10.5 Audit, outcome measures and comparative studies . 17 10.5.1 Monitoring short-term and long-term treatment outcomes 17 10.5.2 National data sets National Registers and Databases 18 10.5.3 Future developments 18 11 Information and education needs 18 11.1 Famil
15、ies/Caregivers . 18 11.1.1 General . 18 11.1.2 At time of diagnosis (pre and post natal) 18 11.1.3 Preparation for surgery . 19 11.1.4 Longer term care pathway 19 11.2 Health professionals . 19 11.3 Social services and education providers 20 11.4 Governments, healthcare service providers and the gen
16、eral public . 20 12 Information production . 20 Annex A (informative) Types of cleft lip and/or palate 21 A.1 General . 21 A.2 Incomplete cleft lip 21 A.3 Cleft of the soft palate . 21 A.4 Complete cleft lip . 22 A.5 Cleft of the soft and hard palate 22 A.6 Unilateral cleft lip and palate (alveolus
17、involved) 22 A.7 Bilateral cleft lip and palate (alveolus involved) 22 Annex B (informative) Pierre Robin Sequence and treatment options (Subclause 4.1.2) . 23 B.1 Pierre Robin Sequence . 23 B.2 Suggested treatment options . 23 Annex C (informative) Bottles and teats used for assisted feeding of bab
18、ies with cleft. 25 C.1 Example of a squeezable bottle . 25 C.2 Example of squeezable teat 26 C.3 Example of a sipper spout 27 Annex D (informative) Description of the role of a nurse specializing in cleft care . 28 Annex E (informative) Sample form used for feeding assessment of babies with cleft 29
19、 Annex F (informative) Recommendations on treatment records . 33 F.1 General . 33 F.2 Minimum treatment records . 33 F.3 Timing of minimum records . 34 Bibliography 36 PD CEN/TR 16824:2015CEN/TR 16824:2015 (E) 4 Foreword This document (CEN/TR 16824:2015) has been prepared by Technical Committee CEN/
20、TC 424 “Project Committee - Care services for cleft lip and/or palate”, the secretariat of which is held by ASI. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any
21、or all such patent rights. PD CEN/TR 16824:2015CEN/TR 16824:2015 (E) 5 Introduction In Europe around 1 in 700 babies is born with cleft lip and/or palate, the most common congenital anomaly of the head and neck region. The incidence is approximately 1,6 per 1 000 live births, but there is some varia
22、nce across Europe 1. Estimates indicate there are over 900 000 individuals (babies, children and adults) with clefts in Europe 2 - a significant figure, especially when one considers that not only the patients but also their families are affected in terms of psychosocial adjustment and having to end
23、ure the burden of a long treatment pathway. In round figures the incidence by type of cleft may be summarized as follows 3: Table 1 Incidence of Type of Cleft 1)Type of Cleft Percent of Total Cleft palate only 50 % Cleft lip (alveolus) only 20 % Cleft lip and palate 20 % Bilateral cleft lip and pala
24、te 10 % In some cases the cleft may be associated with other problems which need specialist management and these need to be identified early 4. Accurate diagnosis (antenatal or post natal), the provision of appropriate information and support for the family, and the establishment of a structured car
25、e pathway, especially in the early months, will ensure that these infants thrive and develop like all other children. Access to good treatment varies widely throughout Europe, meaning that many children born with clefts are never given the opportunity to realize their full potential. The concept of
26、a comprehensive specialist-team approach to care is not universal. Furthermore babies with clefts are still institutionalized in some countries in Europe 5. The aim of this report is to provide an informative document which can be used by those countries where national protocols need to be establish
27、ed. 1) For further information on different types of cleft see Annex A. PD CEN/TR 16824:2015CEN/TR 16824:2015 (E) 6 1 Scope This Technical Report specifies recommendations for the care of babies born with cleft lip and/or cleft palate at time of diagnosis (ante- and/or postnatal) and the year follow
28、ing birth or diagnosis (whichever is later), including referral processes, establishment of feeding, parental support and care pathways. Recommendations on all aspects of surgery, including timing and the use of pre surgical orthopaedics is excluded. 2 Terms and definitions For the purpose of this d
29、ocument, the following terms and definitions apply. 2.1 assisted feeding use of a soft, squeezable, bottle and/or adjusted teat and/or sipper spout to allow delivery of milk to the infant who is unable to generate suction to extract fluid independently Note 1 to entry: It enables the infant to feed,
30、 effectively and safely, the required volume within an acceptable time frame. Note 2 to entry: For further information on types of bottles and teats used for assisted feeding of babies born with clefts see Annex C. 2.2 cleft centre hospital with a designated cleft team and paediatric facilities 2.3
31、cleft surgeon surgeon trained in cleft surgery with a major commitment to cleft care and who practices cleft surgery on a regular and frequent basis 2.4 cleft team multidisciplinary team which comprises the following members with proven competence in their field of expertise, paediatric experience a
32、nd a major commitment to cleft care: a care coordinator/manager of the service; a surgeon trained in primary cleft surgery; a surgeon specializing in secondary cleft surgery such as bone grafting and orthognathic surgery; an orthodontist; a speech and language therapist; a nurse specializing in clef
33、t care; a psychologist with recognized clinical training; an audiologist; an ENT surgeon; a geneticist; a restorative dentist; a paediatric dentist; a dental technician Note 1 to entry: While not all specialities will be required for every patient, access to all these practitioners is available when
34、 needed. Note 2 to entry: If patients receive some aspects of care nearer home (e.g. orthodontics, speech and language therapy) they receive care by trained specialists working in collaboration with the cleft team. 2.5 Eurocleft Eurocleft Project 1996 2000 funded by the European Commission having th
35、e aim to improve management and understanding of cleft lip and palate and create a network of European researchers and clinicians to facilitate information exchange PD CEN/TR 16824:2015CEN/TR 16824:2015 (E) 7 2.6 cleft support organization non-medical group with paid staff and/or volunteers offering
36、 advice and support to families affected by cleft 2.7 nurse specializing in cleft care specialist responsible for planning and coordination of early cleft care, including feeding assessment, development of a feeding plan, providing support to the family and liaising with other health care profession
37、als Note 1 to entry: In the absence of a nurse, these services are provided by another trained professional with similar skills. Note 2 to entry: An illustrative role of a nurse specializing in cleft care is provided in Annex C. 2.8 palatal plate presurgical orthopaedics intraoral appliance which ca
38、n be used in the treatment of infants with cleft palate Note 1 to entry: It can help with feeding and can be used to improve physiological tongue position and to influence maxillary growth in preparation for surgery. Note 2 to entry: In newborns with Pierre-Robin-Sequence a plate with velar extensio
39、n can be helpful to treat upper airway obstruction and avoid invasive surgical procedures, e.g. tracheostomy. 2.9 Pierre Robin Sequence sequence of symptoms present in a newborn; micrognathia (small lower jaw), cleft palate, and glossoptosis (posteriorly placed tongue) that combine to cause airway o
40、bstruction Note 1 to entry: The back of the tongue falls back, particularly when the baby is supine, and occludes the airway. 3 Diagnosis and referrals 3.1 Antenatal diagnosis 3.1.1 Recommendations on making the diagnosis The foetal face can be studied with ultrasound very early in gestation. Examin
41、ation of the foetal face should be a component of guidelines for second trimester ultrasound examination 6. 3.1.2 Limitation of ultrasound Although the correct ultrasound examination technique should enable clefting of the upper lip to be identified, it is difficult to detect an isolated cleft palat
42、e antenatally 7. What is often described as a cleft palate on ultrasound may be just a cleft alveolus. Training of the professional undertaking the ultrasound diagnosis should include information on basic embryology of clefting and how treatment of clefts is managed. 3.1.3 Suspected cleft lip and/or
43、 palate If a cleft has been suspected, there should be a referral to a specialist in ultrasound diagnostics to confirm the diagnosis. As a cleft lip and/or palate may be associated with other anomalies, early assessment and diagnosis is necessary. PD CEN/TR 16824:2015CEN/TR 16824:2015 (E) 8 Clear in
44、formation about cleft lip and palate should be given to families if a cleft is suspected. Genetic counselling for patients and families should be available on request. The main topic for discussion is the association with other anomalies and the recurrence risk for following pregnancy. If the cleft
45、is part of a complex syndrome, specific information about it and about the foetus viability should be given to parents during the meeting. In the absence of other anomalies, a foetus with a cleft does not require a change in standard obstetric care. 3.1.4 Recommendations on referral to the cleft tea
46、m The following recommendations should be followed: a referral from the antenatal diagnostics unit to a multidisciplinary cleft team and to a cleft support organization (where it exists) should be made as early as possible after diagnosis; the referring unit should ensure it maintains up to date con
47、tact information on the local or regional cleft team(s); parents should be contacted by a member of the cleft team as soon as possible after receiving the referral; and parents should be offered a face to face meeting with a member of the cleft team within one month of the confirmed diagnosis. The a
48、im of the referral to the cleft team is to provide parents with support and counselling, giving clear information about treatment and successful management of cleft lip and palate. Families do not generally expect the diagnosis or know anything about cleft lip and palate and they have a lot of quest
49、ions and concerns about bringing up a child with a cleft. Some families may be thinking about terminating the pregnancy. Psychosocial support for parents who are expecting a child with a cleft should be available. Parents may need help in normalizing the pregnancy and understanding that the cleft does not define the baby. The following topics may need addressing: grief adjustment process; possible feeling of guilt; impact on the family; how to handle reactions from others; and whether or not it will be possible to breast feed. P
