CEN/TR 16824:2015

SLOVENSKI STANDARD
01-maj-2015
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Early care services for babies born with cleft lip and/or palate
Fürsorgedienstleistungen für Babies mit Lippen-, Kiefer- und Gaumenspalten
Services de prise en charge précoce des bébés nés avec une fente labiale et/ou palatine
Ta slovenski standard je istoveten z: CEN/TR 16824:2015
ICS:
11.020.10 Zdravstvene storitve na Health care services in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL REPORT
CEN/TR 16824
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
March 2015
ICS 11.020
English Version
Early care services for babies born with cleft lip and/or palate
Services de prise en charge précoce des bébés nés avec Fürsorgedienstleistungen für Babies mit Lippen-, Kiefer-
une fente labiale et/ou palatine 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.

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, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 16824:2015 E
worldwide for CEN national Members.

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 diagnosis .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 assessment .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 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 Recommendations 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 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
10.2.2 In-patient care . 17
10.3 Clinical governance . 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 Families/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 general 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 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 babies 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
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

Foreword
This document (CEN/TR 16824:2015) has been prepared by Technical Committee CEN/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 or all such patent rights.
Introduction
In Europe
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