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Management of Neonatal Respiratory Distress Syndrome European Consensus Guidelines 2010 Update

Management of Neonatal Respiratory Distress Syndrome European Consensus Guidelines 2010 Update. Ola Didrik Saugstad, MD Department of Pediatric Research Oslo University Hospital, University of Oslo, Norway Kiev, Nov 30th 2011. European Guidelines on RDS: 2010.

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Management of Neonatal Respiratory Distress Syndrome European Consensus Guidelines 2010 Update

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  1. Management of Neonatal Respiratory Distress Syndrome European Consensus Guidelines 2010 Update Ola Didrik Saugstad, MD Department of Pediatric Research Oslo University Hospital, University of Oslo, Norway Kiev, Nov 30th 2011

  2. European Guidelines on RDS: 2010 • European panel of experts convened under auspices of EAPM to develop evidence-based guidelines on management of RDS. Supported by an unrestricted educational grant from Chiesi Farmaceutici but none of the panel members received honoraria for their contributions. • HLH and CPS are consultants to Chiesi • ODS and VPC members of the Chiesi Advisory Board

  3. European Consensus Guideline Panel • Virgilio Carnielli Ancona, Italy • Gorm Griesen Copenhagen, Denmark • Henry Halliday Belfast, UK • Mikko Hallman Oulu, Finland • Eren Ozek Istanbul, Turkey • Richard Plavka Prague, Czech Republic • Ola Saugstad Oslo, Norway • Umberto Simeoni Marseille, France • Christian Speer Wurzburg, Germany • David Sweet Belfast, UK (Secretary)

  4. Updated Guidelines: 2010What is New? Guidelines contain new evidence from recent Cochrane reviews and the literature since 2007. Many of the previous recommendations on surfactant and CPAP are now more firmly evidence-based. The section on delivery room stabilisation has been considerably expanded. New recommendations on delaying cord clamping and a new section on avoiding or reducing duration of mechanical ventilation, including recommendations on caffeine therapy, nasal ventilation, permissive hypercarbia and the role of newer ventilator modalities. A new miscellaneous section has also been added covering aspects of RDS management that arise infrequently

  5. Aims • Discuss controversies in RDS management • Examine the evidence for best practice • Develop consensus guidelines from evidence available up to end of 2009 • Publish the consensus recommendations on management of RDS in 2010, updating those of 2007

  6. RDS - Definition • Pulmonary insufficiency starting at birth • Mainly confirmed to preterm babies • Caused by lack of alveolar surfactant • Presents with respiratory distress • Development of respiratory failure • Natural course is death or recovery after 3-4 days • Classical X-Ray appearances • Ground glass appearance • Air bronchograms

  7. Chest radiograph before and after surfactant

  8. RDS - Treatment • Oxygen • CPAP • Mechanical ventilation • Surfactant replacement • Supportive Care

  9. RDS – Aims of Management • Maximise numbers of survivors • Minimise potential adverse effects of disease or therapy • Many interventions have been studied in randomised controlled clinical trials and systematic reviews

  10. Grades of Evidence and Levels of Recommendation • A = Meta-analysis or high quality RCT • B = Smaller RCT or systematic review of case-control studies • C = Good quality case-control or cohort study • D = Case series or expert opinion • Modified from SIGN guidelines handbook www.sign.ac.uk/guidelines/fulltext/50 /

  11. European Guidelines on RDS: 2010 • Prenatal Care • Delivery Room Stabilisation • Surfactant Therapy • Oxygen Supplementation Beyond Stabilisation • Role of CPAP • Mechanical Ventilation (MV) Strategies • Avoiding or Reducing Duration of MV • Prophylactic Treatment for Sepsis • Supportive Care: thermal, fluid and nutrition, tissue perfusion, ductus arteriosus • Miscellaneous Considerations

  12. Management of RDS can be influenced before birth • Consider place of delivery • Role of infection in initiation of preterm labour • Role of antibiotics? • Role of antenatal steroids • Which steroid? • How many courses? • Who should get them? • Role of tocolytic agents • Allow steroids to take effect or time to transfer

  13. Prenatal Care Recommendations: 2010 • Mothers at high risk should be transferred to a perinatal centre (C) • Single course of prenatal steroids should be given if threatened preterm labour from 23 to 35 wk gestation (A) • Antibiotics should be given to mothers with PPROM (A) • Consider short-term tocolytics to allow transfer in utero or time to complete course of steroids (A) • Consider a second course of steroids if risk of RDS outweighs uncertainty about long-term adverse effects (D). Multiple pregnancy might be an example (C).

  14. Delivery Room Stabilisation • Babies with RDS have difficulty maintaining FRC and alveolar aeration. • Traditionally, many are resuscitated with bag & mask using 100% oxygen and there is emerging evidence that 100% oxygen may be harmful • Many are intubated for prophylactic surfactant • Uncontrolled tidal volumes are also detrimental to the immature lung and early CPAP is being advocated • Delayed clamping of the cord may confer benefits • Hypothermia should be avoided

  15. Delivery Room Stabilisation – Recommendations - 1 • If possible, delay cord clamping for at least 30-45 sec (A). • Oxygen should be controlled with a blender and the lowest possible concentration should be used (~30%), provided there is an adequate heart rate response (B). • 30% oxygen to start and titrate using pulse oximetry but note normal sats may be 40-60%, reaching 50-80% by 5 min but should be >85% by 10 min. Avoid hyperoxia (B). • If spontaneous breathing, stabilise with CPAP of 5-6 cm water via mask or prongs (B). If breathing is insufficient consider a sustained inflation rather than IPPV (B). • Ventilation with a T-piece device is preferable to a self-inflating or flow-inflating bag to generate PEEP (C).

  16. Delivery Room Stabilisation – Recommendations - 2 • If PPV is needed avoid excessive tidal volumes and maintain PEEP (D). • Reserve intubation for babies not responding to PPV or those requiring surfactant (D). • Verify correct position of the endotracheal tube using colorimetric CO2 detection (D). • Plastic bags or occlusive wrapping under radiant warmers should be used for babies < 28 weeks’ gestation (A).

  17. Surfactant Therapy • Surfactants have revolutionised respiratory care over past 2 decades, and when given prophylactically or as rescue therapy reduce death and pulmonary airleaks in RDS • Many RCTs have been performed to determine the best surfactant, and the optimal timing of dosing and redosing • However, most trials were in the era of low prenatal steroid and CPAP use

  18. Surfactant Therapy – dosing and redosing • At least 100 mg/kg phospholipid is required and 200 mg/kg may be better for established RDS • Administration by bolus results in better distribution • Prophylaxis reduces mortality and air leaks, but more babies end up being treated • Surfactant can be given whilst avoiding mechanical ventilation using INSURE technique • A second (and occasionally a third) dose is sometimes required

  19. Surfactant Therapy - Recommendations • Babies with or at high risk of RDS should be given a natural surfactant preparation (A). • Prophylaxis for most babies < 26 weeks’ gestation. Prophylaxis also if intubation required (A). • Early rescue for untreated babies if evidence of RDS such as increasing oxygen requirement (A). • Poractant alfa200 mg/kg is better than 100 mg/kg (of poractant or beractant) for moderate to severe RDS (B). • Consider early extubation to CPAP if stable (B). • A 2nd/ 3rd dose should be given if ongoing evidence of RDS such as persistent oxygen or MV need (A).

  20. Comparison of Animal Derived Surfactants *High Plasmalogen content is associated with lower BPD rate. Rudiger et al. AJP 2005

  21. Tracheal Aspirates with High Levels of Plasmalogens Associated with Lower BPD Rates Aspirates were collected prospectively from preterm infants ≤32 wks GA intubated within 1hr of birth P<0.001 X X 5 X X 4 X X 3 X % DMAs on all Fatty Acids X X 2 X 1 BPD non BPD Rüdiger M, et al. Critical Care Med. 2000;28:1572-1577

  22. Comparison of Animal Derived SurfactantsCurosurf vs. Survanta (5 studies)

  23. Curosurf vs. Survanta – Rescue Trial (6) No Difference in Death or BPD Speer C et al. Arch Dis Child 1995; 72: F8-F13

  24. Curosurf vs. Survanta – Rescue Trial (6) Changes in FiO2 , PIP & MAP PIP & MAP FiO2 Faster Weaning Speer C et al. Arch Dis Child 1995; 72: F8-F13

  25. FiO2 vs. Time curves after the first dose of Surfactant (n=293) Trial #8 Faster Weaning FiO2 * * 0 15’ 30’ 2 h 6 h Ramanathan R et al. AJP 21:109-119; 2004 Data : Mean  SEM *,* = p < 0.05

  26. % of Infants Requiring Additional Doses of Surfactant #8 Fewer Doses * % Infants * p < 0.05 36 % (C200) vs. 68 % (S100) received 2 or more doses

  27. Curosurf vs. Survanta (n=50): (Rescue Trial # 10)Less Air Leaks & PDA with Curosurf P = 0.002 % P = 0.047 Fujii AM et al. J Perinatol, 1-6; March 2010

  28. Meta-analysis – Curosurf vs Survanta Trials (6&8)* (* Speer et al. & *Ramanathan et al.)Halliday HL. Biol Neonate 2005; 87:317-22

  29. Mortality of 3 different surfactants Ramanthan et al Journal of Perinatology (2011), 1–7

  30. Mortality of 3 different surfactants Ramanthan et al Journal of Perinatology (2011), 1–7

  31. Cost per patient: Curosurf vs. Survanta  53% ($ 950)  46% ($ 618)  20% ($ 220)  20% ($ 200) Cost / Patient ($) Cost Effective Model 1: Speer et al (mean wt, single-use vial) Model 2: Ramanathan et al. (mean wt, single-use vial) Model 3: Ramanathan et al. (Actual wt, single-use vial) p=<0.01 Model 4: Ramanathan et al. (Actual wt, Survanta as multi-use vial)p=0.018 Marsh W, Smeeding J, York JM, Ramanathan R, Sekar K. JPPT 9:113-121; 2004

  32. Surfactant for RDS: Evidence Based Approach • Animal Derived Surfactants: Faster weaning of O2, and MAP, Fewer air leaks, and Decreased Mortality when compared to synthetic Surfactants. • Among Animal Derived Surfactants, Porcine surfactant, Curosurf provides Faster Weaning, Rapid Extubation, Less PDA, Survival Advantage & Cost-effectiveness when compared to Bovine surfactants, Survanta or Infasurf • Best Timing: < 60 minutes of Age

  33. Why Poractant Alfa (Curosurf)?

  34. Guidelines for Surfactant Treatment of RDS

  35. Oxygen supplementation beyond stabilisation • Currently no firm evidence to guide optimal oxygen saturations in NICU • Suggestions to target between 85% and 93% and not exceed 95% to reduce ROP and BPD • Long-term neuro-developmental outcomes are unknown • Hyperoxia can occur following surfactant therapy • Fluctuations in oxygen saturations may also increase the risk of ROP • Optimal saturation targets currently being studied in BOOST-II, COT and SUPPORT

  36. Oxygen supplementation beyond stabilisation • In oxygen, saturations should be maintained at all times between 85 and 93% (D). • After surfactant, avoid a hyperoxic peak, which is associated with IVH, by rapid reduction in oxygen (C). • Avoid fluctuations in oxygen saturations in the postnatal period (D).

  37. What is new and why this topic? Stabilisation/Resuscitation: How to titrate FiO2 if oxygen is needed? Optimal FiO2 for preterm infants is not known Oxygen saturation beyond the DR in ELBWI: New data on mortality has created uncertainty of safety A too low SpO2 reduces ROP and BPD but increases mortality Consequences for clinical practice Previous reccommendations of SpO2 targets should perhap be changed

  38. Should we resuscitate extremely low birth weight infants with a low FiO2?

  39. High (90% Vs low (30%) FiO2 Resuscitating ELBWIs Raquel E et al Pediatrics May 2008

  40. SpO2 in extremely low gestational age neonates 120 100 80 SpO2 (%) 60 40 20 0 0 5 10 15 20 25 30 35 Time after birth (min) Hox group (n=41) Lox group (n=37) Vento et al, Pediatrics 2009

  41. Isofurans ** **

  42. How could SpO2 centiles be used to inform decision making in the DR? Dawson, Vento, Finer, Rich, Saugstad, Morley, Davis J Pediatrics 2011

  43. TRANSITIONAL OXYGEN TRACKING SYSTEM Allowing to individualize FiO2 avoiding hyper/hypoxia 50% 10% Rich W et al non published data 2010

  44. High or Low Saturation for ELBWIs?Effect on BPD and ROP At least 9 studies have been published investigating the effect on BPD and ROP of low or high oxygen saturation in VLBWI or ELBWIS. Of these 3 only are randomized

  45. Studies regarding high or low SpO2 targets in VLBWI or ELBWIs – Characterisation of Studies Saugstad and Aune, Neonatology 2010;100:1-8.

  46. BPD and SpO2 Saugstad and Aune, Neonatology 2010;100:1-8.

  47. ROP and SpO2 Saugstad and Aune, Neonatology 2010;100:1-8.

  48. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial Wolfgang Göpel, MD, Angela Kribs, MD, Andreas Ziegler, PhD, Reinhard Laux, MD, Thomas Hoehn, MD, Christian Wieg, MD, Jens Siegel, MD, Stefan Avenarius, MD, Axel von der Wense, MD, Matthias Vochem, MD, Peter Groneck, MD, Ursula Weller, MD, Jens Möller, MD, Christoph Härtel, MD, Sebastian Haller, MD, Bernhard Roth, MD, Egbert Herting, PhD and on behalf of the German Neonatal Network The Lancet September 30, 2011 Terms and Conditions

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