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Multicenter study led by pitt finds early results of therapy for preemies not sustained
November 03, 2009Inhaled nitric oxide (iNO), a therapy used in the treatment of premature newborns with respiratory failure that had shown promising results in short-term studies, does not significantly improve long-term outcomes, according to a national study led by critical care researchers at the University of Pittsburgh School of Medicine and Children's Hospital of Pittsburgh of UPMC.
Previous studies of inhaled nitric oxide in premature babies with respiratory failure suggested improvements in early outcomes, but this study of nearly 800 infants found no significant improvement in survival rates at 1 year of age and no change in longer term respiratory or neurological function.
"We were surprised by these findings, because previous studies had suggested short-term benefits of iNO in the treatment of respiratory failure," said first author R. Scott Watson, M.D., M.P.H., assistant professor of critical care medicine and pediatrics, University of Pittsburgh School of Medicine, and an intensivist in the Division of Critical Care Medicine at Children's Hospital and a researcher in the Clinical Research, Investigation & Systems Modeling of Acute Illness (CRISMA) Laboratory in the Department of Critical Care Medicine. "Further study will determine if a different dose, longer duration of therapy and/or use in a different subgroup of premature babies would be effective."
Results of the study are published in the November issue of Pediatrics, the official journal of the American Academy of Pediatrics.
Researchers conducted long-term follow-up of premature newborns from 16 centers in the United States who were born at 34 weeks or earlier and weighed between 500 and 1,250 grams and were enrolled in a study testing whether iNO could prevent chronic lung disease. Babies received five parts per million of iNO or a placebo within the first two days of birth and continuing for 21 days (or until the patient was taken off a ventilator). Of the 590 babies with complete survival data, 77 percent survived to one year of age (79 percent of those receiving iNO and 75 percent of those receiving placebo).
At 1 year of age, less than 6 percent of study participants were still receiving supplemental oxygen, but most had continued neurologic impairment. Less than 38 percent of survivors were unimpaired and nearly 35 percent had severe neurologic impairment. In all, nearly 45 percent of patients from the study had died, were on oxygen, or had neurologic impairment, and there were no significant differences between those who had received iNO and those who had received placebo.
"This was an important study because iNO has been proven an effective therapy for the treatment of respiratory failure in late-term and term infants," Dr. Watson said. "However, it may not be effective for smaller babies born at 34 weeks or younger. In addition, the discrepancy between the short-term and longer-term findings suggests that the conventional way of studying treatment for clinically ill infants and children, by looking at outcomes that develop in the hospital, is not enough to understand whether the treatments really work. We need to routinely study longer-term outcomes that are important to how children grow and develop over time."
University of Pittsburgh Schools of the Health Sciences
Results of the study are published in the November issue of Pediatrics, the official journal of the American Academy of Pediatrics.
Researchers conducted long-term follow-up of premature newborns from 16 centers in the United States who were born at 34 weeks or earlier and weighed between 500 and 1,250 grams and were enrolled in a study testing whether iNO could prevent chronic lung disease. Babies received five parts per million of iNO or a placebo within the first two days of birth and continuing for 21 days (or until the patient was taken off a ventilator). Of the 590 babies with complete survival data, 77 percent survived to one year of age (79 percent of those receiving iNO and 75 percent of those receiving placebo).
At 1 year of age, less than 6 percent of study participants were still receiving supplemental oxygen, but most had continued neurologic impairment. Less than 38 percent of survivors were unimpaired and nearly 35 percent had severe neurologic impairment. In all, nearly 45 percent of patients from the study had died, were on oxygen, or had neurologic impairment, and there were no significant differences between those who had received iNO and those who had received placebo.
"This was an important study because iNO has been proven an effective therapy for the treatment of respiratory failure in late-term and term infants," Dr. Watson said. "However, it may not be effective for smaller babies born at 34 weeks or younger. In addition, the discrepancy between the short-term and longer-term findings suggests that the conventional way of studying treatment for clinically ill infants and children, by looking at outcomes that develop in the hospital, is not enough to understand whether the treatments really work. We need to routinely study longer-term outcomes that are important to how children grow and develop over time."
University of Pittsburgh Schools of the Health Sciences
Respiratory Failure Current Events and Respiratory Failure News RSSMechanical ventilation for patients with lung damage don't always work as planned
As more Canadians are diagnosed with H1N1 influenza infection, some will be admitted to hospital. The most severely affected may be treated in the intensive care unit (ICU) and placed on a mechanical ventilator to help them breathe while they recover from the infection.
Muscle weakness a common side effect of long stays in intensive care units
After decades of focusing on the management of respiratory failure, circulatory shock and severe infections that lead to extended stays in hospital intensive care units, critical care researchers are increasingly turning attention to what they believe is a treatable complication developed by many who spend days or weeks confined to an ICU bed: debilitating muscle weakness that can linger long after hospital discharge.
H1N1 critical illness can occur rapidly; predominantly affects young patients
Critical illness among Canadian patients with 2009 influenza A(H1N1) occurred rapidly after hospital admission, often in young adults, and was associated with severely low levels of oxygen in the blood, multi-system organ failure, a need for prolonged mechanical ventilation, and frequent use of rescue therapies.
Most H1N1 patients with respiratory failure treated with oxygenating system survive illness
Despite the severity of disease and the intensity of treatment, most patients in Australia and New Zealand who experienced respiratory failure as a result of 2009 influenza A(H1N1) and were treated with a system that adds oxygen to the patient's blood survived the disease.
Intensive care procedure saves lives: Swine flu study
A research team has warned medical experts in the Northern Hemisphere not to underestimate the serious impact of the H1N1 (Swine flu) virus with a new report showing that many patients who were critically ill with the virus required prolonged life support treatment with heart-lung machines.
Should noninvasive ventilation be considered a high-risk procedure during an epidemic?
Contrary to current policies recommending that non-invasive ventilation be avoided during an infectious outbreak, the author of a commentary in CMAJ (Canadian Medical Association Journal) argues that it should be used expeditiously in this setting.
Implementation of acute care surgery service provides more timely patient care
A new study published in the October issue of the Journal of the American College of Surgeons shows that the establishment of an acute care surgery service can help surgeons at academic medical centers provide more timely care to the growing number of patients who are transferred from the emergency room or smaller hospitals and who require an immediate operation.
Mutation responsible for cystic fibrosis also involved in muscle atrophy
Patients with cystic fibrosis (CF) usually experience significant muscle loss, a symptom traditionally considered to be a secondary complication of the devastating genetic disease.
Nitrous gases and zinc in the crosshairs
The Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area established by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) has issued the MAK and BAT Values List for 2009. This year's list contains 62 changes and new entries.
Low birth weight linked to long-term respiratory problems
Infants who weigh less than five and a half pounds at birth often enter the world with a host of medical complications, including respiratory problems.
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