PEDIATRICS Vol. 96 No. 6 December 1995, pp. 1147-1151
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Inhaled Nitric Oxide for Persistent Pulmonary Hypertension of the Newborn: Implications and Strategy for Future "High-Tech" Neonatal Clinical Trials

Ann R. Stark MD1 and Dennis Davidson MD2

1 Joint Program in Neonatology, Department of Pediatrics, Harvard Medical School, Children's Hospital, Boston, MA
2 Division of Neonatal-Perinatal Medicine, Albert Einstein College of Medicine, Schneider Children's Hospital, New Hyde Park, NY

Five large clinical trials are in progress in the United States and Canada examining the efficacy and safety of inhaled nitric oxide (iNO) for persistent pulmonary hypertension of the newborn (PPHN) and severe respiratory failure in near-term and term infants. A large trial in France that includes premature infants is also under way. Neonatologists have shown great interest in the use of iNO as a selective pulmonary vasodilator, but in the United States and perhaps elsewhere, widespread application of this treatment outside of study sites will have to await completion of clinical trials. At the current pace, we expect it will take several years to enroll an adequate number of patients to address relevant outcome end-points.

Submitted on April 20, 1995
Accepted on August 3, 1995




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