METABOLIC BONE DISEASE OF PREMATURITY NEONATAL CLINICAL GUIDELINE V3.0 Page 1 of 10
1. Aim/Purpose of this Guideline To provide guidance on the prevention of metabolic bone disease in the neonate. All involved will benefit from the improvements in service and timing 2. The Guidance 2.1. Background Preterm infants are at significant risk of poor bone mineralization. There is a nutritional deficit in calcium and phosphate supply in breast milk compared to the inutero environment. After 24 weeks gestation the fetus actively acquires the majority of these minerals via the placenta and bone mineralisation occurs. Metabolic bone disease is thought to be predominantly related to phosphate deficiency. The onset is usually between 3-12 weeks of life. The problem is usually silent until severe demineralisation occurs with osteopaenia, rickets and fractures. Prevention is better than treatment of established disease. Incidence is up to 55% in those born under 1000g and is much higher in unfortified breast milk fed preterms. There is little consensus on diagnostic criteria, monitoring or treatment so the following based mainly on Grade IV evidence. 2.2. Risk Factors <32 weeks BW <1500g Breast milk fed preterms Loop diuretic use Corticosteroid use Prolonged parenteral nutrition Cholestasis (conjugated bilirubin >20 mmol/l) 2.3. Features Decreased bone mineralisation on x-ray and in some cases, rickets and fractures (late sign) Raised alkaline phosphatase (>500 IU/L) Low serum phosphate (<1.8mmol/l) Poor growth 2.4. Prevention Phosphate supplements (1mmol/kg/day) should be added to expressed breast milk (EBM) for all babies born at less than 32 weeks gestation (unless on breast milk fortifier) once established on full feeds 2. Sodium Phosphate 17.9% has 1mmol Na and 0.5mmol PO4 per ml and is probably better split into two doses due to concerns regarding high osmolality fluids in the gut contributing to necrotizing enterocolitis. Each 0.5mmol phosphate needs a minimum of 10ml EBM 5. Infants fed with preterm Page 2 of 10
formulas are likely to have adequate mineral intake and do not need routine supplementation with calcium or phosphate. Vitamin supplementation of 0.6ml DALIVIT daily in all breast or formula fed infants < 32 weeks gestation Daily passive exercises may help to improve bone mineralisation 7. 2.5. Subsequent monitoring Weekly bloods including bone profile for all preterms. If persistently rising alkaline phosphatase (>500IU/L) despite prophylaxis, consider calculating the urinary tubular reabsorption of phosphate (TRP). If TRP >95%, this suggests that phosphate supplementation is still insufficient and increasing or adding phosphate supplementation is appropriate 3. TRP % = (1 - ( Urine phosphate / Urinary Creatinine ) x ( Plasma Creatinine / Plasma phosphate )) x 100 Note for above equation all units must be the same (mmol/l) therefore divide serum Creatinine(μmol/L) by 1000. Smart phone apps will calculate this for you. Be careful with units. Calculator here: http://baspath.co.uk/calculations/renal_tubular_reabsorption_of_ph.htm Phosphate supplementation can sometime unmask a calcium deficiency and infants may need calcium supplementation. This should be done at alternate times to phosphate to eliminate risks of co-precipitation in milk. Continue supplements until the bone profile has normalised and ideally stop phosphate supplements prior to discharge. If there are on-going concerns, monthly outpatient bone profiles can be arranged. Page 3 of 10
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 in practice recommended by guidance Dr Chris Warren, Dr Paul Munyard. Consultant Paediatricians and Neonatologists Audit To be included in Neonatal Clinical Audit Programme Findings reported to the Child Health Audit Meeting / Clinical Governance meeting As dictated by Audit findings Child Health Directorate Audit and Clinical Governance meetings Dr Paul Munyard. Consultant Paediatrician and Neonatologist Required changes to practice will be identified and actioned within 3 months of audit. 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 4. Equality and Diversity 4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement. 4.2. Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2. Page 4 of 10
Appendix 1. Governance Information Document Title Metabolic bone disease of Prematurity Neonatal Clinical guideline V3.0 Date Issued/Approved: 21 st February 2018 Date Valid From: 21 st February 2018 Date Valid To: 21 st February 2021 Directorate / Department responsible (author/owner): Paul Munyard. Consultant Paediatrician and Neonatologist Contact details: (01872) 253293 Brief summary of contents Suggested Keywords: Target Audience Executive Director responsible for Policy: This guideline is designed to ensure the implementation of a standardised approach to the management of infants at risk of metabolic bone disease Neonate. Metabolic bone disease. Newborn RCHT CFT KCCG Medical Director Date revised: February 2018 This document replaces (exact title of previous version): Approval route (names of committees)/consultation: Divisional Manager confirming approval processes Metabolic bone disease of Prematurity Neonatal Clinical guideline V2.0 Neonatal Consultants. Child Health Guidelines and Audit meetings David Smith Name and Post Title of additional signatories Name and Signature of Divisional/Directorate Governance Lead confirming approval by specialty and divisional management meetings Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Not required {Original Copy Signed} Name: Caroline Amukusana {Original Copy Signed} Internet & Intranet Intranet Only Page 5 of 10
Document Library Folder/Sub Folder Links to key external standards Related Documents: Training Need Identified? Clinical / Neonatal None 1. Abrahms SA. Calcium and phosphorus requirements in newborn infants. Uptodate. 2011. 2. Bishop N. Metabolic bone disease. Rennie and Roberton, 4 th ed, 2005. 3. Harrison CM et al. Osteopenia of prematurity: a national survey and review of practice. Acta Pædiatrica 2008 97, pp. 407 413 4. Abrahms SA et al. High frequencies of elevated alkaline phosphatase activity and rickets exist in extremely low birth weight infants despite current nutritional support. BMC Pediatrics 2009, 9:47. 5. Jones E et al. Feeding and Nutrition in the Preterm infant. Elsevier Churchill Livingstone 2005. 6. Agostoni C et al. Enteral Nutrient Supply for Preterm Infants: Commentary from the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition Committee on Nutrition. Journal of Pediatric Gastroenterology and Nutrition 2010, 50:1 9. 7. Moyer-Mileur LJ et al. Daily physical activity program increases bone mineralization and growth in preterm very low birth weight infants. Pediatrics 2000; 106: 1088 92. No Version Control Table Date Version No June 2012 V1.0 March 2014 Initial Issue Summary of Changes V2.0 Review and Reformatting Changes Made by (Name and Job Title) Paul Munyard. Consultant Paediatrician and Neonatologist Reviewer: Paul Munyard. Formatter: Kim Smith February 2018 V3.0 Review and reformatting No other changes Page 6 of 10
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 10
Appendix 2. Initial Equality Impact Assessment Form This assessment will need to be completed in stages to allow for adequate consultation with the relevant groups. Name of Name of the strategy / policy /proposal / service function to be assessed Clinical Guideline for The Prevention of Metabolic Bone Disease in the Neonate. V3.0 Directorate and service area: Child Health Name of individual completing assessment: Paul Munyard Is this a new or existing Policy? Existing Telephone: (01872) 25 3293 1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at? 2. Policy Objectives* As above. To provide guidance on the prevention of metabolic bone disease in the neonate. The guideline is aimed at hospital based medical and nursing staff. 3. Policy intended Outcomes* Evidence based and standardised practice. 4. *How will you measure the outcome? 5. Who is intended to benefit from the policy? 6a Who did you consult with b). Please identify the groups who have been consulted about this procedure. What was the outcome of the consultation? Audit Neonatal medical and nursing staff Neonatal patients Workforce Patients Local groups Please record specific names of groups Neonatal Guidelines Group Divisional Board Meeting Guideline agreed External organisations Other Page 8 of 10
7. The Impact Please complete the following table. If you are unsure/don t know if there is a negative impact you need to repeat the consultation step. Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Unsure Rationale for Assessment / Existing Evidence Age Sex (male, female, trans-gender / gender reassignment) Race / Ethnic communities /groups Disability - Learning disability, physical impairment, sensory impairment, mental health conditions and some long term health conditions. Religion / other beliefs Marriage and Civil partnership Pregnancy and maternity Sexual Orientation, 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 this relates to service redesign or development 8. Please indicate if a full equality analysis is recommended. Yes No 9. If you are not recommending a Full Impact assessment please explain why. No areas indicated Page 9 of 10
Signature of policy developer / lead manager / director Paul Munyard Date of completion and submission 21 st February 2018 Names and signatures of members carrying out the Screening Assessment 1. Paul Munyard 2. Human Rights, Equality & Inclusion Lead 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 This EIA will not be uploaded to the Trust website without the signature of the Human Rights, Equality & Inclusion Lead. A summary of the results will be published on the Trust s web site. Signed Paul Munyard Date 21/02/2018 Page 10 of 10