CHOP neonatologists Haresh Kirpalani, BM, MRCP, FRCP, MSc, and Barbara Schmidt, MD, FRCP(C), MSc, have spent more than 30 years pioneering evidence-based medicine in neonatology and mentoring the next generation of leaders in the field. They have spent the past 10 years in the Division of Neonatology at Children’s Hospital of Philadelphia (CHOP), where they created a culture of rigor and excellence in clinical research. Now poised on the brink of retirement, they took time to reflect on how the field has evolved and their visions for its future.

Much has changed since they began their careers. It was the 1970s, and neonatology was a relatively new field. Clinicians were just beginning to get their heads around how a preterm or sick baby’s body functions. Relatively few people saw the need for evidence-based medicine in neonatology. New therapies were often initiated with limited understanding of their long-term impact on a child. The field was wide open for study.

Where it all began

Dr. Kirpalani, born in India and educated in the United Kingdom, and Dr. Schmidt, born and educated in Germany, met at the Hospital for Sick Children in Toronto, at the beginning of their fellowships in neonatology. Both developed an interest in studying not only short-term but also long-term neonatal outcomes such as growth and development in an effort to improve survival, decrease morbidities, and promote future health. They married in 1986 and spent the next 20 years in Canada, mostly at McMaster University, where they were formally introduced to the principles of evidence-based medicine.

Looking back on their careers, they are most proud of raising the profile of evidence-based medicine in neonatology. They have led several high-profile randomized clinical trials that have proven the need for a rigorous approach to measuring how a baby does over the long term in order to understand the risks and benefits of interventions. In addition, Dr. Kirpalani co-founded the International Society for Evidence-based Neonatology (EBNEO), a nonprofit organization that promotes his vision that all neonatal care should be firmly built on the best available evidence.

One study led by Dr. Schmidt examined the effect of caffeine in more than 2,000 very low birth weight infants in North America, Europe, Israel, and Australia. Study participants were followed into middle-school age. Caffeine therapy had been used for years with little understanding of its long-term benefits and risks. Dr. Schmidt’s study showed conclusively that caffeine therapy for apnea of prematurity improves the rate of survival without neurodevelopmental disability up to 2 years after very preterm birth and reduces the risk of motor impairment even as late as age 11. The Caffeine for Apnea of Prematurity (CAP) trial was named the Inaugural Clinical Trial of the Year in 2008 by the Society of Clinical Trials and Project Impact.

Mentoring the next generation of neonatologists

At the bedside, Drs. Kirpalani and Schmidt taught residents and fellows the practice of evidence-based medicine. Their work cultivating the next generation of leaders has earned numerous excellence in teaching honors, both in Canada and at CHOP, where Dr. Kirpalani served as Program Director of the Newborn/Infant Chronic Lung Disease Program, and Dr. Schmidt as Director of Clinical Research for the Division of Neonatology.

Dr. Kirpalani was named CHOP Mentor of the Year in 2015. Some of the key tenets he has stressed to mentees over the years are the importance of teamwork and selflessness, and embracing parents as part of the team.

“I learned some of the most important things that helped me become a critical care physician from nurses in the ICU,” he says. “They offered so much experience, so easily, and put no emphasis on it. They just gave. At the end of the day, with the high-quality care that we are giving, it is absolutely critical to have a very open teamwork basis.”

Drs. Kirpalani and Schmidt are discouraged by a trend toward increasing bureaucracy, over-regulation, and hurdles in performing long-term studies like theirs. As a result, they say it has become harder to entice young physicians into a career in clinical research.

“The whole research enterprise has become so cumbersome and time consuming that it doesn’t leave a lot of energy to do actual research,” says Schmidt, who recently received the Order of Canada, an honor similar to receiving the Presidential Medal of Freedom, for her contributions to advancing the standard of care for critically ill newborns in Canada and abroad. “The excitement of discovery has been replaced by dread of the relentless bureaucracy.”

“You have to be bright and be willing to give up a lot and put in a lot to make it in the research field,” adds Schmidt. “We both hope going forward that the hurdles around research come down rather than go up further, so that very talented and spirited individuals don’t get discouraged.”

A Clinical Research Symposium was held in their honor in May and highlighted evidence-based medicine and innovative, randomized clinical trials in neonatology. Read more about the event in this Cornerstone blog post.