A breakthrough drug, tagged by specialists as a significant advancement in perinatal care, is being used in Utah to save the lives and reduce the long-term complications of Mountain West newborns with lung problems.
Neonatologists at the Primary Children's Medical Center, University of Utah Health Sciences Center and LDS Hospital have initiated a second study with the drug surfactant.The Utah trial is one of 12 in the United States using it to "rescue" children suffering from hyaline membrane disease.
"It appears we may be able to diminish a number of acute and chronic lung problems . . . as well as length of hospital stay and long-term morbidity," said Dr. Richard A. Molteni, director of Primary Children's Newborn Intensive Care Unit and one of three principal Utah investigators in the new drug study.
Dr. August L. Jung, director of the U. Division of Neonatology, and Dr. David M. Coulter, director of LDS Hospital's newborn ICU, are the other investigators conducting the study. Their hope is to gain the federal Food and Drug Administration's approval of the drug for general use.
An ongoing study at the U. Hospital has shown the surfactant derivatives, when administered at birth, have been successful in preventing respiratory problems in newborns of less than 33 weeks gestation.
In fact, said Jung, the treatment has been extremely effective in inducing near-normal lung function in premature lambs and in the human studies.
More than 400 babies have been studied at the U. to identify any adverse side effects when the drug is given at birth to prevent respiratory distress syndrome.
Within the last year alone, the drug was administered to two sets of Utah quadruplets to keep the small air sacs in the babies' lungs open. It has also been used for 70 babies for "compassionate" care, treating severe, established disease and risk of death from respiratory problems.
The new study, launched two weeks ago, involves babies who already suffer from respiratory distress. Three recipients - newborns from Wyoming, St. George and Salt Lake City - are currently in Primary's newborn ICU. One is already off the respirator - good news to researchers.
"Surfactant treatment is less fraught with complications than respiratory therapy and could lessen the need for invasive treatment such as high-frequency jet ventilator," Coulter said.
In the new study, researchers are addressing the efficacy of the drug in diminishing mortality, ventilator and oxygen complications such as air leaks, lung injury and chronic lung disease. Their hope is that it will ultimately help reduce hospitalization time and expense.
Here's how the drug works:
Infasurf, extracted from ground calf lungs, acts as a detergent in the baby's lungs, coating air sacs and lowering surface tension, which prevents air sacs from collapsing. The medicine is introduced into the child's airway through an endotracheal tube in small amounts over a short time span.
The earlier the drug is administered, the better. With 35 percent of the babies coming to the three neo-natology units suffering from hyaline membrane disease, researchers say the study is desperately needed.
In the control study, specialists randomly select half the babies to receive surfactant; half initially are not given the drug. However, should any baby's condition become severe, he will be given the drug.
Other types of preparations in use in Japan, Europe and the United States include extracts of cow and pig lungs and human surfactant isolated from fluid obtained during the birth of babies. These studies are not being done in Utah, however.