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2006 Annual Report:
The Pediatric Heart Lung Center
Pediatric Faculty Lead Groundbreaking
Study
Using Inhaled Nitric Oxide
John Kinsella, MD, and Steve Abman, MD, from the Pediatric
Heart Lung Center (PHLC), were the first doctors ever to
use inhaled nitric oxide (iNO) to treat a premature infant
with respiratory failure. They are also the authors of a major
multicenter clinical trial for iNO therapy to prevent chronic
respiratory complications. Their study, published in the July
27, 2006 issue of the New England Journal of Medicine, found
that use of iNO could significantly lower the risk of lung and
brain damage in very low birth weight premature infants.
The Pediatric Heart Lung Center
John Kinsella, MD (left) and Steve Abman, MD (right), Professors
of Pediatrics, with a patient in the Newborn Intensive Care Unit at
The Children’s Hospital, 2006
Drs. Kinsella and Abman first used iNO in severely ill
low birth weight premature infants about 15 years ago. “The
therapy had been approved by the FDA to treat pulmonary
hypertension in term newborns,” Dr. Abman said, “but
whether premature infants would benefit from iNO therapy
had been uncertain.” Drs. Abman and Kinsella began studying
this possible therapy–based on promising findings in the
PHLC laboratory–in a pilot trial in the 1990s.
“We were the first to use inhaled nitric oxide to treat
a premature baby with respiratory failure,”
Dr. Abman said, “but without a large randomized
trial, the efficacy of iNO therapy in
premature newborns was unknown.”
The results of the initial pilot study in 1999
were promising–enough so that Dr. Kinsella
designed a trial to determine its safety and
efficacy with funding from the National Heart,
Lung and Blood Institute. “With 793 infants
enrolled, this was the largest study of iNO in premature
newborns,” Dr. Kinsella said.
“Our latest findings are the result of seven years of work,
if you include its conception, design and implementation,”
Dr. Abman said. “This trial is a major landmark study in
this area.”
The trial, which the PHLC conducted with 16 other centers
during five years, looked at preterm babies on mechanical
ventilators the first two days after delivery. Half were treated
with iNO and half received a placebo, but treatment remained
blinded to care providers and families. Patients were divided
into three categories based on weight.
“The babies who received nitric oxide at a low dose in the
first 48 hours after delivery had a significant reduction in
key signs of brain injury,” Dr. Abman said. In addition, preterm infants with a birth weight of about 2 pounds had a
50 percent reduction in bronchopulmonary dysplasia.
“Although the improvement in bronchopulmonary dysplasia
demonstrated in this trial is important, the
most exciting finding is the decreased risk
of severe brain injury in infants treated with
iNO,” Dr. Kinsella said. “This is one of the
few interventions in premature babies that
could improve long-term neurodevelopmental
outcomes.”
The trial was the result of much group effort
throughout The Children’s Hospital and the
University of Colorado Denver.
“So many people came together for this clinical trial,
including laboratory and clinician scientists, to meet in a
collaborative way to solve critical problems. It’s very exciting
to be able to learn about something in the lab and then apply
it to the bedside.”
“The most important outcome of the study,” Dr. Abman
said, “is the benefits for patients and families. We are especially grateful for the support of so many
families for participating in this study and are excited to
offer something that can enhance long-term outcomes for
premature newborns.”
The impact of this iNO clinical research has had far-reaching
effects in the field and may change the way neonatal medicine
is practiced.
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