Neonatal Resuscitation Program™ and Helping Babies Breathe® The past, present, and future of neonatal resuscitation efforts worldwide (and lessons learned along the way) Good afternoon! On behalf of the American Academy of Pediatrics, I thank you for inviting us to be here with you this week to conduct training sessions in our Helping Babies Breathe program. We are extremely pleased with how well the program has been received…and the extent of its reach…over these short 18 months since it was launched in June 2010. Neonatal resuscitation has been a professional…and personal…passion of mine for many years. I am honored to have this opportunity today to talk with you about the past, present and future of neonatal resuscitation efforts worldwide…as well as some of the lessons I personally have learned along the way. Errol R. Alden, MD, FAAP AAP Executive Director/CEO November 2011

Objectives Provide an overview of the AAP’s “Neonatal Resuscitation Program” and “Helping Babies Breathe” Highlight the importance of working with local authorities Demonstrate the translation of science into practice Share lessons learned

Neonatal Resuscitation Of the 130 million babies born each year, about 4 million die in the first 4 weeks of life. A quarter of these deaths are due to asphyxia. It is estimated that an additional million develop problems such as cerebral palsy and other disabilities. World Health Report 2005

Neonatal Resuscitation The vast majority of newborn infants do not require intervention from intrauterine to extrauterine life. Approximately 10% of newborns require some assistance to begin breathing at birth. About 1% of newborns require extensive resuscitation

Inverted Pyramid of Neonatal Resuscitation 136 million babies born Assessment at Birth and Simple Newborn Care All infants Initial Steps: Drying, Warmth, Clearing the Airway, Stimulation Approx 10 million babies Approx 6 million babies Some infants Positive-Pressure Ventilation However, the benefits to be realized are enormous. Recent estimates published in the October supplement to the International Journal of Obstetrics and Gynecology suggest that 16 million babies could be helped – saved from death or possible disability – through universal application of neonatal resuscitation. Chest Compressions < 1.4 million babies Few infants Medications Wall, Lee, Niermeyer et al. IJGO 2009

Pathophysiologic Cardio-Pulmonary Consequences of Asphyxia Dad knew what to do… The science is there. Dawes Foetal and Neonatal Physiology. Year Book Medical Publishers Inc; 1968.

Some Recommendations for Resuscitation (1850-1950) Rectal stimulation (stretching of the rectum with a corn cob) Tobacco smoke blown into the rectum Immersion into cold water(+ alternating with warm water) Before NRP there were some novel approaches to Neonatal Resuscitation.

Some Recommendations for Resuscitation (1850-1950) Intragastric oxygen Rhythmic traction of the tongue Rubbing, slapping, and pinching Raising and lowering of the arms, while an assistant compresses the chest O2

Consequences of Poor Neonatal Resuscitation Increased Death Increased Disability Emotional & Financial Burden Direct Community Costs Loss of Productivity

Neonatal Resuscitation Program mid-1970s: Dr Bloom and Cathy Cropley receive NICHD award to develop an initial simple way to focus neonatal resuscitation teaching 1981: Dr George Peckham, an AHA volunteer and AAP Perinatal Section Chair, advocated for development of a standardized core curriculum 1985: Dr Peckham and Dr Leon Chameides discussed models and outlined the “train the trainer” approach for dissemination Ron Bloom The AAP takes up the mantle… Cathy Cropley

Neonatal Resuscitation Program 1986: Dr Peckham and Dr Bill Keenan, AAP Perinatal Section Leaders, began seeking buy-in from neonatology community for such an endeavor First NRP textbook (1987): based on consensus opinions of leaders in neonatology regarding what was “accepted” practice First 2-day NRP course occurred in November 1987

The Neonatal Resuscitation Program American Academy of Pediatrics American Heart Association The NRP is designed to guide resuscitation of the newborn infant in the critical few minutes during and immediately following birth.

NRP: Program Goal To have at least one person trained in neonatal resuscitation present at every delivery in the United States.

Mead Johnson Nutritionals: Neonatal Resuscitation Early NRP Click again to play the video! Mead Johnson Nutritionals: Neonatal Resuscitation

NRP: US Program History In 24 years: 2.9 million providers have been trained/retrained. Currently in the United States: There are more than 27,000 active instructors. Approximately 130 courses are held each day. May want to note: that we are only approximately 30,000 providers away from having trained/retrained 3 million providers!

Lesson #2: Convince others the mission is their own After establishing the NRP as an effective tool for teaching neonatal resuscitation in the US, we took on the task of disseminating the message around the world. Through thousands of hours of volunteer time, the NRP has been established in Laos…Thailand…Turkey…Romania…Brazil…Egypt…and China. Major key to our success was recognizing that the most effective strategy is to convince others that the mission is their own – rather than a simple implementation of what others have advocated. These photos were taken during our trip to teach the program in Romania in December 1991. That marked the first time the AAP took the program international. Romania 1991

NRP 6th Edition Update Pulse oximetry added Meconium suctioning recommendations changed Use of supplemental oxygen during resuscitation Use of Pulse Oximetry • Having pulse oximeters available in delivery areas is encouraged and is highly recommended for use whenever supplemental oxygen, positive pressure ventilation or continuous positive airway pressure are considered necessary. • If chances are high that you’re going to deliver a pre-term infant, the guidelines recommend having an oximeter immediately available for application. Elimination of Evaluation of Amniotic Fluid in Initial Rapid Assessment • Results from a randomized controlled study concluded if a baby is crying and breathing well, there is no reason to treat a meconium-stained baby any differently than a baby born through clear fluid, except for continuing to evaluate the baby carefully for evidence of compromise. That evaluation should be able to take place while the baby remains with the mother. • Meconium has been removed from the rapid assessment algorithm regarding the four questions to ask when deciding whether or not to begin resuscitation; thus, an active meconium-stained newborn can be kept with his mother. • If a baby is floppy and bradycardic he should be brought to the resuscitation table to be intubated and meconium-stained baby’s trachea suctioned; however, if the baby has good tone and is breathing well despite the presence of meconium, the baby should remain with his mother. Use of Supplemental Oxygen During Neonatal Resuscitation • In most infants, beginning resuscitation with 100% supplemental oxygen offers no apparent advantage over beginning resuscitation with 21% oxygen. • Using room air may be associated with slightly lower mortality rates. • Using 100% oxygen may result in some degree of measurable tissue injury • The latest available scientific evidence has shown that the concept of increasing a newborn’s oxygen level as fast as possible with 100% supplemental oxygen is probably not the best approach. Rather, starting resuscitation of term babies with room air (ie: no supplemental oxygen) and carefully assessing the amount of oxygen needed for both term and preterm babies will be the recommendation. • Additional epidemiologic studies suggest that exposure to supplemental oxygen in the delivery room can cause short- and long-term issues; however, further prospective studies are needed to confirm this observation.

NRP 6th Edition Update, Continued Increase time between initiating chest compressions and interrupting compressions to assess heart rate Induced therapeutic hypothermia Simulation-based educational methodology Chest Compressions • Chest compression to ventilation ratio will remain the same with three chest compressions to one ventilation (3:1). • If chest compressions are started, whenever possible, performing endotracheal intubation is strongly recommended. • Use of the two-thumb versus the two-finger technique is preferred. (Studies performed by Dr Myra Wyckoff have shown that using two-thumb technique to deliver compressions results in a greater amount of time that compressions will be performed to correct depth and rate) • Increase time between initiating chest compressions and interrupting compressions to assess heart rate from 30 seconds to 45-60 seconds or longer. Induced Therapeutic Hypothermia • Use induced therapeutic hypothermia in a tertiary care center when it can be implemented using well-defined protocols and where appropriate follow-up is available. Teaching Methodologies for Encouraging Simulation and Debriefing • A majority of studies demonstrate that the use of simulation-based learning methodologies enhances learner performance in simulated resuscitations in laboratory and classroom settings and may improve resuscitation quality in real-life clinical situations. • In the classroom setting, the primary focus of the new NRP will be a realistic active learning environment with hands-on skills practice, case-based resuscitation scenarios and team briefing and debriefing sessions following hands-on training exercises.

Textbook of Neonatal Resuscitation, 6th Edition, 2011 NRP Now Click slide again when you’re ready to play video! This video is showing a pulse oximeter probe being attached to a baby's right hand.  Pulse Oximetry is new to the NRP 6th Edition An oximeter should be used to confirm the perception of cyanosis (this replaces the "color" assessment on the old algorithm. Rationale for switch is bulleted below). Studies have shown that clinical assessment of skin color is not very reliable, and varies as a function of skin pigmentation. Other studies have documented that babies undergoing normal transition may take several minutes after birth to increase their blood oxygen saturation from approximately 60%, which is the normal intrauterine state, to more than 90%, which is the eventual state of air-breathing healthy newborns. It is not unusual for a newborn to appear slightly cyanotic for the first few minutes after birth.  If the cyanosis persists, you should attach a pulse oximetry probe to determine if the baby's oxygenation is abnormal.  If the levels are low and not increasing, you may need to provide supplemental oxygen.  Other changes to the 6th edition include meconium suctioning and de-emphasis on using 100% oxygen (this is what the NRP THEN video shows - so may be helpful to tie in here that there are several changes with the 6th Ed).  Textbook of Neonatal Resuscitation, 6th Edition, 2011

NRP Outcomes Asphyxia decreased in 10 provinces in China after training with NRP. (Huishan et al 2008) In the first decade, deaths due to birth asphyxia in the US decreased 42%. (Wegman 1991) Introduction of NRP in 10 hospitals in India reduced overall neonatal mortality by 7 per 1000. (Deorari 2000)

NRP Outcomes, Continued Intrauterine hypoxia and birth asphyxia was: the 10th leading cause of infant death in 1996 – a 72.4% change since 1979. the 14th leading cause of infant death in 2008 – a 79.5% change since 1979. Side note: since the annual summary of vital stats only covers the top 10 leading causes, intrauterine hypoxia and birth asphyxia is not listed on the most recent table published in Pediatrics. Thus, the graphic on this slide is for 1996. Guyer B et al. Annual Summary of Vital Statistics - 1996 Pediatrics 1997; 100:90

the NRP is the most widely used NRP: Reach of Program Although reporting of international NRP courses is voluntary, training has been reported in more than 125 countries and translated into 26 languages. Of all the educational material produced by the American Academy of Pediatrics, the NRP is the most widely used around the world.

Lesson #3: Expertise doesn’t necessarily equal ability to teach Our trip to Laos and Thailand was quite the experience. Stories: Switching boxes of program materials Laos participant offered a true compliment: “This is the first time anyone has ever taught me how to teach neonatal resuscitation.” Laos & Thailand

Lesson #4: Being an expert in your own country doesn’t mean you’re an expert in other countries. We also found that…in order to effectively export the NRP…we needed to make sure the program was accepted and endorsed by the local experts…and then delivered in their language.

Transferability….to more than 125 countries NRP Reach Sites of NRP Implementation Over and over in the ILCOR guidelines process and the international dissemination of NRP it became clear that there was a huge unmet need – a need to train birth attendants in simple livesaving skills in areas of the world where neonatal mortality is the highest. Transferability….to more than 125 countries

Lesson #5: Humor may not translate, but laughter is universal Some of my favorite memories involve traveling around the world…teaching neonatal resuscitation to our colleagues in other countries. Our adventures have been both educational and enjoyable...and I learned the importance of being able to see the humor in even the most trying situations. Take for example our trip to Romania… Far Side cartoon Nursing chair Data: “What numbers would you like to see?”

NRP in Developing Countries While NRP has been embraced internationally, the content and format is routinely altered to meet the needs of the learners in developing countries.

NRP in Developing Countries The challenge has been to develop a curriculum, based on the same rigorous science of NRP, that is culturally effective and meets the needs of those who live in resource limited settings.

NRP in Developing Countries Developing an effective curriculum for limited resource settings would impact Millennium Development Goal #4, which is to reduce by two thirds, the under-five mortality rate.

Helping Babies Breathe® An educational program for birth attendants in first-level health facilities and the community Strong educational methodology to promote mastery and utilization of bag-mask ventilation Pictorial materials Pair learning/teaching with purpose-built simulator Support for continued practice and learning Reinforcement of lifesaving fundamentals of care for all babies and development of additional lifesaving skills of bag and mask ventilation: Cleanliness Warmth Early breastfeeding Catalyst for further development of the perinatal health care system

Global Causes of Neonatal Death The causes of neonatal death globally also remind us that infection and prematurity, play major roles in addition to asphyxia. Any intervention must address not only asphyxia, but also cleanliness and hygiene as well as warmth and early nutrition for small babies. A forthcoming meta-analysis of in-facility resuscitation training concluded that death from asphyxia, or intrapartum-related events, could be reduced by 30% in term infants and preterm mortality reduced by 5-10% through neonatal resuscitation. [International Journal of Obstetrics and Gynecology 107 (2008) S47-S64] UNICEF 2007 Lee, Wall, Cousens et al. Int J Epidemiol (in press) 31

Big Target of Helping Babies Breathe How many babies are dying? Globally, nearly 4 million newborns die each year in the first month of life. As seen before, about one quarter of these die because they fail to breathe at birth – a simple definition of asphyxia. In addition to these, there are over 3 million babies who are termed stillbirths . Among these are some babies who just are not breathing, and who can be helped with simple measures. Together, each year hundreds of thousands of babies can be helped to breathe at birth. 1 million “stillbirths” due to asphyxia 830,000 neonatal deaths due to asphyxia Lawn JE et al. IJGO 2009; 107:S5 32

Helping Babies Breathe Concept International Liaison Committee on Resuscitation (ILCOR) Science Harmonious With NRP & WHO Recommendation, if feasible Non-Profit, Inclusive Directed To Resource Limited Conditions - Single Provider ILCOR (International Liaison Committee on Resuscitation) Going forward, all of ILCOR will meet once per year. ILCOR’s neonatal delegation, however, will still meet twice per year.

Helping Babies Breathe Curricular Concept Pictorial Limited Text Hands On Performance Frequent Skills Practice Simplest Steps “Possible” The Golden Minute

Hands on Practice 35

Educational Design Adult Learning - TOT, Visual Tool kit Hands on Performance - OSCE Evidence-Based Learner to Facilitator - 6:1 Learning in Pairs TOT = Training of Trainers OSCE = Objective Structured Clinical Examination

Paired Teaching/Learning

Neonatal Physiology Hypoxia-apnea, slow heart rate Breathing for the Baby-rapid reversal Delays-increase mortality, morbidity

Field Testing Educational Approaches Tanzania, Kenya, India, Pakistan Modified MCQ, Problem-Solving, OSCE Simulator India Implementation Studies Kenya, India, Bangladesh

Educational Field Testing Birth Attendants Increase Level of Skills Attained Testing OSCE Revision of MCQs Revision of Bag/Mask Instruction Revision of OSCEs

Implementation Field Testing Knowledge Acquisition improved Skills Testing – 98% Passed Resuscitation Required ↑ Stimulation ↓ BMV, Suction 6-12 Hours of Training Summary from two field studies in Tanzania and Kenya. These are results that are reported to us and I generally do not put them forward as conclusive, only encouraging. Knowledge Acquisition--significant and consistent improvement in the multiple choice answers Skills Testing--at the end of the training 98% of all participants passed the Bag and Mask Skills testing and both OSCEs. This is the major step in the educational evaluation. Resuscitation Required--showed the changes in directly observed resuscitation practice in Tanzania. Somewhat redundant but % of babies requiring resuscitation went down, more early steps were used and less Bag and Mask Ventilation or airway suctioning was used. Hours of Training--what time these successful courses used to achieve the results.

Clinical Outcomes ↓ death at 24 hours among babies not breathing at birth (RR = 0.46) with no change in stillbirths - Tanzania N=6928/7277 pre/post training ↓ stillbirths (RR = 0.73) with no change in neonatal deaths – India N=4173/5427 pre/post training Initial data from field testing; not yet published Note: different groups with different needs make analysis of the data difficult

Helping Babies Breathe Tool Kit Action Plan Learner Workbook Facilitator Flip Chart Multiple Choice Questions OSCE Simulator-Purpose Built Bag/Mask/Suction/Stethoscope Objective Structured Clinical Examination (OSCE)

Flipchart Simulator Workbook 44

Routine Care Clearing the airway if meconium present Drying infant Recognize crying Keeping warm Cutting the umbilical cord Encouraging breastfeeding 45

The Golden Minute® Recognizing infant not crying Positioning head Clearing the airway Stimulating Recognizing breathing Initiating ventilation by 1 minute 46

Global Development Alliance for Country-Wide Implementation American Academy of Pediatrics US Agency for International Development Saving Newborn Lives/Save the Children Eunice Kennedy Shriver National Institute of Child Health and Human Development Laerdal Global Health I’d like to welcome a few partners who are at the course today: From the AAP HBB Task Force – George Little, Rob Clark, Jonathan Spector From USAID – Troy Jacobs From NICHD – Linda Wright These individuals bring a great deal of experience teaching both NRP and HBB around the world.

Global Development Alliance Overall Objective Reduce newborn mortality due to asphyxia Guiding Principles Inclusiveness and collaboration Country-owned and country-led Integration with maternal and essential newborn care Shared goal, results, and recognition Brand non-exclusivity To support the implementation of Helping Babies Breathe on a large scale, key organizations involved in the development of HBB have joined together in a Global Development Alliance, with the overall objective to reduce newborn mortality due to asphyxia. USAID through it implementing partners is supporting training programs at national scale. NICHD, the National Institute of Child Health and Human Development, is working to improve methods for monitoring and evaluation, and recently received fnding for a large impact evaluation of HBB. Save the Children serves as a catalyst to build partnerships among stakeholders and strengthen health policy. Laerdal Medical is working to improve the functionality and availability of both training materials and clinical equipment. The American Academy of Pediatrics supports advocacy and training with technical expertise and a commitment to ongoing revision and improvement of materials to reflect new science and evaluation by users in the field. 48

Global Development Alliance The GDA continues to grow each day with new partners: Johnson and Johnson Latter Day Saints Charities Soon to be added: Columbia University Earth Institute Millennium Villages/Cities Project International Pediatric Association You’ve already met Rob Clark who represents Latter Day Saints Charities and brings a unique family practice perspective to the partnership. I’d also like to welcome to Jason Sperinck from Johnson and Johnson and Elana Jacobs from Millennium Villages, who are also attending the HBB course.

Ongoing Steps Global Development Alliance NICHD Studies Country-wide Implementation Facilitator Video Translations ENC (Essential Newborn Care) and EMONC (Emergency Obstetric and Neonatal Care) ENC = Essential Newborn Care EMONC = Emergency Obstetric and Neonatal Care

Fit with Essential Newborn Care Thermal Protection Clean Delivery Cord Management Early Breast Feeding Resuscitation As Required

Hypothesis From Experience Improving Skill in Neonatal Resuscitation Spurs Improvements in Other Components of Early Neonatal Care.

Helping Babies Breathe Sustainability Simple and evidence- based Low-cost and effective Easy to integrate with other essential parts of NB care The program is designed be sustainable and integrated into the health system. Although HBB can be used alone as a complete resuscitation course, it is easily integrated into Essential Newborn Care as the resuscitation component. Training can become part of preservice education as well as inservice education. Learners are encouraged to continue their learning outside the classroom with supervised practice in the clinical setting, self-reflective learning, and case reviews. Helping Babies Breathe can serve as the keystone for further development of maternal and neonatal care into an integrated system of perinatal care and quality improvement. This in-charge nurse in a rural health post in Kenya is beaming because at last she sees a way that she can train her staff to help babies breathe and make a difference in her community. She took the baby in her arms and renamed her Gladys. 53

Big Hairy Audacious Goal BHAG Big Hairy Audacious Goal To have at least one person trained in neonatal resuscitation present at every delivery in the WORLD

Helping Babies Breathe This video shows the work of Helping Babies Breathe-trained birth attendants in Eldoret, Kenya.

Lesson #6: A healthy first cry represents a baby with unlimited potential Share story re: how quiet things are in the delivery room are until the baby lets out its first cry and the tension quickly lowers.

Thank you for taking the time from your busy schedules to attend this Grand Rounds session. It’s been an honor and a privilege to be here with you today and to have this opportunity to share some of the American Academy of Pediatrics’ efforts to ensure that every baby gets the same start at life…regardless of where he or she is born. At this time, let’s open the floor to questions and/or comments.