Routine use of inhaled nitric oxide discouraged for preterm infants

An independent panel convened by the NIH concluded that the overall scientific data do not support the use of inhaled nitric oxide in the routine clinical care of premature infants born before 34 weeks’ gestation.

Although inhaled nitric oxide is approved for term and near-term infants with pulmonary hypertension, the panel concluded that this treatment should be considered only for certain premature infant subgroups, and only when other clinical options have been exhausted.

“In recent years, continuing advances in obstetrics and neonatal intensive care have increased survival of preterm infants,” F. Sessions Cole, MD, conference panel chairman and director of the division of newborn medicine at Washington University School of Medicine, St. Louis, said in a press release. “However, these babies remain at substantial risk for medical problems that can create lifelong challenges. We need safe and effective treatments, but the current evidence does not point to inhaled nitric oxide as providing a clear benefit to most of these children.”

The consensus development panel examined combined evidence from 14 randomized controlled trials of nitric oxide in premature infants born at or before 34 weeks’ gestation and concluded that as a whole, the studies did not show a favorable result on survival or lung function. The panel recommended that future trials examine the relative contributions of different treatment regimens and use larger sample sizes to assess safety and efficacy among different subgroups of premature infants. The panel concluded that long-term follow-up studies are necessary to determine the balance of treatment risks and benefits, but there are difficulties in conducting this research.

“Inhaled nitric oxide affects multiple organ systems, and developing premature infants are especially vulnerable to adverse treatment effects, long after they leave the neonatal intensive care unit. If further trials are pursued, children must be followed at least through school age,” Cole said in the release. “Unfortunately, this research is not only logistically challenging but, in many cases, very expensive.”

In addition, the panel suggested that clinicians provide families with clear and accurate information about this treatment option to ensure that they make an informed decision on treatment.

Premature infants often suffer from respiratory problems caused by their underdeveloped lungs. During the past decade, many of these infants have been treated with inhaled nitric oxide — a treatment designed to ease breathing by widening blood vessels in the lungs.

Premature infants, in general, face increased risk for adverse outcomes, including death, lung disease, and neurodevelopmental problems such as cerebral palsy, blindness and learning disabilities. In 1999, the FDA approved inhaled nitric oxide therapy to treat one of these risks — pulmonary hypertension — in term and near-term infants. Since that time, some hospitals have extended the use of nitric oxide on an off-label basis for babies born at less than 34 weeks’ gestation in the hope of promising results.

The conference was sponsored by the NIH Office of Medical Applications of Research and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with other NIH and US Department of Health and Human Services components. The conference was conducted under the NIH Consensus Development Program, which convenes conferences to assess the available scientific evidence and develop objective statements on controversial medical issues.

For more information, visit http://consensus.nih.gov.

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