CEN TR 16824-2015 Early care services for babies born with cleft lip and or palate《唇裂和腭裂婴儿的早期护理》.pdf
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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
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