THE USE OF DONOR BREAST MILK (DBM). NEONATAL CLINICAL GUIDELINE
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1 THE USE OF DONOR BREAST MILK (DBM). NEONATAL CLINICAL GUIDELINE Insufficient mothers own breast milk. AND Infant meets criteria for DBM Refer mother to Breast Feeding Support Nurse for lactation support AND Obtain informed consent for DBM Make up total feed volume with DBM and any available Expressed Breast Milk (EBM) Increase feed volume to optimal level for baby e.g. 150ml/kg Feed tolerated for 48 hours If infant is considered very high risk continue DBM / EBM. Monitor growth. Seek diatetic review. Very High Risk = <27 weeks or <1000g or Recovering from NEC Page 1 of 16 Introduce Formula Day 1 ¼ formula Day 2 ½ formula Day 3 ¾ formula Day 4 Full strength formula Babies <2.0 kg and <35 weeks use preterm formula. Babies >2.0 kg and >35 weeks use post discharge formula Increase proportion of formula as tolerated
2 1. Aim/Purpose of this Guideline 1.1. This guideline aims to Outline the indications for the use of DBM to provide equity of use across the South West Neonatal Network. To outline the transition from DBM to formula. To outline the use, safe storage and traceability of DBM. It applies to all staff caring for babies receiving DBM. 2. The Guidance 2.1 Background. A mother s own breast milk is the best form of nourishment for a preterm infant, in preference to infant formula or donor breast milk. Every support should be given to help mothers produce milk for their baby. Early expression to stimulate hormonal response is crucial to good on-going supply However, in some rare situations maternal expressed breast milk is not available or able to be used. Potential Benefits. Formula fed very low birth weight babies are at significantly increased risk of Necrotising Enterocolitis (NEC) when compared with infants exclusively fed breast milk. Data suggests that DBM reduces the risk of NEC by as much as 79%. Potential Risks. DBM is a human body fluid and, as such, carries risks of transmission of infective agents. Donors are screened and the milk is pasteurised to minimise risk. Written consent must be obtained for the use of DBM. Handling, testing and documentation of the milk in the Donor Milk Bank and specialist feed unit is carried out according to NICE Guidelines DBM use should be a consultant led decision. There is however, currently a lack of evidence to guide its use. Ideally DBM should only be used to test the gut of preterm infants when there is insufficient mother s own milk. Once the infant is tolerating 150ml/kg of milk, if DBM is required to make up the required volume, preterm formula should be gradually substituted (see algorithm) 2.2. Indications. The decision to use DBM must be documented in the notes. If a mother s own milk is not available or contra-indicated, use of DBM should be considered the gold standard for the following babies; All babies less than or equal to 30 weeks gestation or less than 1500g (including multiples). Page 2 of 16
3 Babies less than or equal to 32 weeks gestation with consistently absent/reversed end diastolic flow. Post NEC (medically and surgically treated) Babies transferred on DBM from another unit. Neonatal units may choose to use DBM in the following additional circumstances; Babies less than or equal to 35 weeks gestation with growth restriction below 2 nd centile. Following circulatory collapse requiring complex resuscitation. Haemodynamically unstable babies e.g. requiring or recently requiring inotropic support. Preterm babies receiving medical treatment or awaiting surgical treatment for Patent Ductus Arteriosus. Hypoxic Ischaemic Encephalopathy (moderate/severe). NB. Due to the limited supply of DBM, babies who do not fulfil the above criteria should not be offered DBM even if it might be for a restricted period of time e.g. parents who themselves have allergies but who do not wish to use maternal breast milk (MBM) or standard formula; those babies requiring top up feeds. Breast feeding and lactation support should continue to be provided. If the donor milk bank has insufficient supplies of milk, DBM should be prioritised on a case by case basis within each individual unit. 2.3 Obtaining Consent. THIS MUST BE DOCUMENTED IN THE INFANTS MEDICAL / NURSING NOTES. The nurse or doctor caring for the infant should explain the rationale for using DBM. Written information about DBM is available in the UKAMB leaflet Donor Breast Milk your questions answered. UKABM leaflets Written consent must be obtained from the mother to give DBM to the baby. This consent must be documented in the baby s notes along with the mother s feeding intention. (Appendix 7) A parent information sheet is available to support this discussion. (Appendix 8) If DBM has been consented to, a printable checklist (Appendix 9) is available to ensure correct procedures adhered to and documentation completed. 2.4 How to obtain Donor Breast Milk. Receiving hospitals should comply with relevant clinical governance standards pertaining to the traceability and storage of breast milk before using DBM. This is outlined in the NICE donor milk bank guidelines ( Page 3 of 16
4 North Bristol Trust. (NBT). Human Milk Bank (Precious Drops) Marion Copeland Heidi Evans Southampton Human Milk Bank Oxford Human Milk Bank Jess MacFarlane Sally Inch Milk courier service. 'Bloodbikes'. All DBM administered in the NHS should be from Milk Banks that can demonstrate adherence to the NICE guideline on the operating of DBM Banks. 2.5 Storage and Usage. All DBM received from outside of the Neonatal Unit needs to be logged onto a DBM Log-In Sheet. (Appendix 4). DBM should be stored as directed by the DBM bank and according to each unit s policy for all frozen milk. Milk can be kept in the freezer for 3 months, but not beyond the expiry date. Milk should always arrive in a frozen state. This must be checked by the member of staff that receives the delivery. Milk must be used within 24 hours of removal from the freezer for defrosting 2.6 Traceability Each bottle of milk must be clearly labelled with a batch number and expiry date. Once taken from the freezer the DBM should be labelled with the name and Hospital number of the baby who is to receive the milk, and the date and time it is removed from the freezer. A DBM Log out sheet (Appendix 5) should be completed for every bottle of DBM taken from the freezer documenting the recipient s name and hospital number together with the batch number of the DBM. Each baby receiving DBM should have their own individual Donor Milk Record Sheet (Appendix 6) completed to include date, time, batch number and volume of milk given. This must be signed and countersigned by the nursing staff and the form kept in the baby s hospital records. 2.7 Duration of the use of DBM. DBM can be used for 1-3 weeks after introduction. Once the baby has tolerated 150mls/kg DBM for 48 hours, introduction of formula should be considered (see algorithm Appendix 3) Page 4 of 16
5 Formula milk should be blended with DBM ¼ then ½ then ¾ strength until full strength is tolerated (see algorithm Appendix 3) Babies <35 weeks and <2.0 kg should have preterm formula. Preterm babies >2.0 kg and >35 weeks should have post discharge formula. 2.8 Fortification of DBM. DBM can be fortified but it is preferable to move onto preterm formula once 150ml/kg is tolerated for >48 hours. 2.9 Babies transferred to other units A clear feeding plan should be agreed between the referral and receiving units before transfer. If the receiving hospital is not able to accept the baby on DBM, the baby should be re-graded onto formula as soon as possible before the transfer. If the hospital does accept babies on DBM then a small supply of DBM should be transferred with the infant. It is the responsibility of the receiving hospital to liaise with the established Donor Milk Bank for further supplies of DBM. 3. Monitoring compliance and effectiveness Element to be monitored Lead Tool Frequency Reporting arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be shared Key changes to practice Dr. Paul Munyard Audit As dictated by audit findings Child health Directorate Audit and Neonatal Clinical Guidelines Group Dr. Paul Munyard. Consultant Paediatrician and Neonatologist Required changes to practice will be identified and actioned within 3 months. A lead member of the team will be identified to take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders Page 5 of 16
6 4. Equality and Diversity 4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Diversity & Human Rights Policy' or the Equality and Diversity website Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2. Appendix 1. Governance Information Document Title Date Issued/Approved: March 2016 Donor Breast Milk (DBM) Neonatal Clinical Guideline Date Valid From: JUNE 2016 Date Valid To: JUNE 2019 Directorate / Department responsible (author/owner): Dr. Paul Munyard. Child Health. Neonatal Contact details: Brief summary of contents Suggested Keywords: Target Audience Executive Director responsible for Policy: This guideline aims to outline the indications for the use of Donor Breast Milk to provide equity of use across the South West Neonatal Network. To outline the transition from DBM to formula. To outline the use, safe storage and traceability of DBM. Neonatal. Donor Expressed Breast Milk. DEBM. DBM RCHT PCH CFT KCCG Medical Director Date revised: 25:05:2016 This document replaces (exact title of previous version): Approval route (names of committees)/consultation: New Document Consultant Approval Child health Directorate Audit Neonatal Clinical Guidelines Group Page 6 of 16
7 Divisional Manager confirming approval processes Name and Post Title of additional signatories Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Document Library Folder/Sub Folder Links to key external standards Related Documents: Training Need Identified? David Smith Not Required {Original Copy Signed} Internet & Intranet Intranet Only Neonatal. Clinical. Child Health Governance Team can advise Donor Breast Milk Banks: the operation of donor milk bank services (2010) NICE guidance. CG93. Western Neonatal Network Guidelines Group SW Neonatal Networks Guideline for the use of Donor Breast Milk No Version Control Table Date Versio n No Summary of Changes Changes Made by (Name and Job Title) 20:12:15 V1.0 Initial Issue 21:01:16 V2.0 Addition of appendices Neonatal Guidelines Group Neonatal Guidelines Group All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Page 7 of 16
8 Appendix 2. Initial Equality Impact Assessment Form Name of the strategy / policy /proposal / service function to be assessed (hereafter referred to as policy) (Provide brief description): Directorate and service area: Is this a new or existing Policy? Child and Women s Health. Neonatal New Name of individual completing assessment: Paul Munyard 1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at? 2. Policy Objectives* As above Telephone: This guideline is aimed at clinical staff responsible for the nutritional care of hospitalised infants. 3. Policy intended Outcomes* 4. *How will you measure the outcome? 5. Who is intended to benefit from the policy? 6a) Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? Audit Audit Neonatal Patients Neonatal nursing and medical staff No. Neonatal Guidelines Group Consultant approved guideline. b) If yes, have these *groups been consulted? C). Please list any groups who have been consulted about this procedure. 7. The Impact Please complete the following table. Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Rationale for Assessment / Existing Evidence Age x Page 8 of 16
9 Sex (male, female, transgender / gender reassignment) Race / Ethnic communities /groups Disability - learning disability, physical disability, sensory impairment and mental health problems Religion / other beliefs Marriage and civil partnership Pregnancy and maternity x x x x x x Sexual Orientation, x Bisexual, Gay, heterosexual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked Yes in any column above and No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or Major service redesign or development 8. Please indicate if a full equality analysis is recommended. No 9. If you are not recommending a Full Impact assessment please explain why. No area indicated Signature of policy developer / lead manager / director Paul Munyard Date of completion and submission 01:06:2016 Names and signatures of members carrying out the Screening Assessment Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust s web site. Signed kim smith Date 01:06:2016 Page 9 of 16
10 Appendix 3. Donor Breast Milk (DBM) Algorithm Insufficient mothers own breast milk. AND Infant meets criteria for DBM Refer mother to Breast Feeding Support Nurse for lactation support AND Obtain informed consent for DBM Make up total feed volume with DBM and any available Expressed Breast Milk (EBM) Increase feed volume to optimal level for baby e.g. 150ml/kg Feed tolerated for 48 hours If infant is considered very high risk continue DBM / EBM. Monitor growth. Seek diatetic review. Very High Risk = <27 weeks or <1000g or Recovering from NEC Introduce Formula Day 1 ¼ formula Day 2 ½ formula Day 3 ¾ formula Day 4 Full strength formula Babies <2.0 kg and <35 weeks use preterm formula. Babies >2.0 kg and >35 weeks use post discharge formula Increase proportion of formula as tolerated Page 10 of 16
11 Appendix 4. Donor Breast Milk, Log-In Sheet. For DBM accepted onto Neonatal Unit from DBM Bank or referring hospital. Completed form to be kept in DBM Folder in Nurses Office. Donor Breast Milk Log-In Sheet Date/Time DBM received onto the NNU DBM Bank/ Hospital generating delivery Batch number of bottles Number of bottles received Integrity of DBM. Each bottle should be checked to ensure frozen Signature and name of receiving nurse Page 11 of 16
12 Appendix 5. Donor Breast Milk Log-Out Sheet. Completed form to be kept in DBM Folder, in Nurses Office. Please attach baby s label here Donor Breast Milk Log-Out Sheet Date/Time DBM removed from freezer Batch number Number of bottles taken Recipients name and hospital number Signature and Name. Page 12 of 16
13 Appendix 6. DBM Check Sheet PRECIOUS DROPS MILK BANK DONOR BREAST MILK RECORD SHEET Check milk with second member of staff or parent. Use infants name band as positive patient identifier Do not leave unlabelled milk in a cot or incubator To be kept in infant s notes Please attach baby s label here Date/ Time Batch Number Removed From Freezer Date/Time Volume Given Signature. Print Name. Counter Signature. Print Name. Page 13 of 16
14 Appendix 7. Donor Breast Milk Consent Form PRECIOUS DROPS MILK BANK DONOR BREAST MILK CONSENT FORM (RECIPIENT) This form to be completed when Health Professional is giving donor milk to a baby This Please attach baby s label here Sheet MUST be filed in recipient s case notes for tracking The decision to start using donor breast milk has been documented by a doctor in the baby s medical notes YES/NO I (name)...have read the leaflet Donor Breast Milk and give consent for my baby... to receive donor breast milk. Signed.. Date.. Relationship to baby I (name)..confirm that I have discussed the use of Donor Milk and have answered all questions and concerns. Signed.. Date Job Title.. Page 14 of 16
15 Appendix 8. Donor Breast Milk Parental information Sheet Page 15 of 16
16 Appendix 9 Baby needing donor milk? If you are looking after a baby who needs donor milk please ensure that the following have been undertaken: Please initial, print name and date as proof of completion Parents have had the opportunity to read the leaflet donor breast milk your questions answered. Parents have had the opportunity to ask questions. Medical staff have clearly stated in the notes that baby should start on DBM. Mum, (or Dad, if they are married), has signed the consent form, which is in this file. The decision to start DBM shouldn t be an urgent issue so obtaining written consent should usually be possible; however, verbal consent can be taken in extreme circumstances, as long as parents sign the form as soon as they are able. Once all of the above has been done the DBM should be treated in the same way as frozen MBM. In other words, each baby has their own bottle of milk, with their own name label placed onto the bottle. It should be used within 12 hours from coming out of the freezer. Every time a new batch number is given to the baby please document the details in the NICU donor milk log in this file. Each individual feed should be documented on the baby s feed chart, as per usual; having been checked with 2 members of staff. Any questions about what to do please ask the Nurse in charge, breastfeeding staff or the dietician. Page 16 of 16
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