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Improving Pulmonary Outcomes in Premature Infants Resilient Researcher Pushes Project Forward
In the children’s classic The Little Engine That Could, the Little Blue Engine is confronted with a towering, seemingly impassable mountain and through the power of positive thinking, he ascends the big mountain to eventually make it over the peak.
Neonatologist Richard Parad, MD, MPH and his fellow researchers are applying this childhood lesson to important research that will someday benefit BWH’s tiniest patients. Working on an exciting clinical trial that seeks to improve pulmonary outcomes in premature infants, Parad and his colleagues are experiencing their own “impassable mountain,” as it relates to funding for a second trial. And like the Little Blue Engine, Parad and his colleagues are determined to overcome their challenges as well.
Seeking to explore methods to combat bronchopulmonary dysplasia (BPD), a form of chronic lung disease, and improve pulmonary function in premature infants, Parad and fellow researchers Jonathan M. Davis, MD; Theresa Michele, MD; Elizabeth Allred, PhD; Anita Price, MD; and Warren Rosenfeld, MD; embarked on an innovative clinical trial, published as a lead article in the March 2003 issue of Pediatrics, involving an enzyme called recombinant human CuZn superoxide dismutase (SOD).
“Preliminary studies showed that acute and chronic lung injury may be diminished by this enzyme,” said Parad.
With the increasing survival of babies born at extremely low birth weights and with very underdeveloped lungs, BPD has become a persistent and significant problem for premature infants, as lung injury develops due to the oxygen and mechanical ventilator support these babies need to survive. BPD is often later associated with asthma, respiratory tract infections and in some cases, neurodevelopmental abnormalities.
More than 300 premature infants, with birth weights between 600 and 1200 grams were enrolled in this national, multi-center trial, with 30 infants being from BWH. Half of the babies had SOD administered through a breathing tube into their lungs every 48 hours for up to one month of age, while the other half received a placebo.
“The short-term results were inconclusive, showing no differences between the two groups,” said Parad, who explained that as a result, study enrollment was halted. However, Parad and his team carried out further follow-up with the already enrolled infants at one year of age.
When Parad and his fellow researchers checked in with the babies at this later point, they noted a dramatic difference between the control group and the group who received treatment. “At one year of age, the smallest infants who received the enzyme therapy experienced a 55 percent reduction in their use of asthma medications, a 55 percent decrease in emergency department visits and a 44 percent decline in subsequent hospitalizations,” said Parad. Parad and his team are thrilled with the promising data, as the enzyme appears to be a safe, effective therapy that improves pulmonary outcome in high-risk premature infants. These find-ings have created momentum for further research. “Our next step is to get a second clinical trial underway that will focus on these later-outcome parameters to confirm our findings,” said Parad.
Unfortunately, the pharmaceutical company that produces SOD does not have the resources to fund this next trial. Therefore, Parad and his colleagues are currently applying for funding from several local and federal sources to do just that. “It could take two years before we get this second study off the ground,” he added. “But I am not giving up. Judging from our findings, treatment with this particular drug can highly benefit this growing infant population.”
Like many innovative researchers at BWH, Parad will lead his team to pursue this investigative cause, as it has the potential to impact the health of many premature infants, including the more than 100 babies who receive care on the sixth floor of the Connor’s Center for Women’s Health each year.