Randomized, multicenter trial of inhaled nitric oxide and high-frequency oscillatory ventilation in severe, persistent pulmonary hypertension of the newborn☆,☆☆,★
Section snippets
Organization and Eligibility Criteria
Eight clinical centers with experience in the use of HFOV participated in this trial. The study was approved by the institutional review board at each center and by the U.S. Food and Drug Administration under an investigator-initiated Investigational New Drug exemption. Criteria for enrollment included the following: gestational age 34 weeks or more; severe hypoxemia despite mechanical ventilation with high fraction of inspired oxygen (partial pressure of arterial oxygen < 80 mm Hg in F io 2 =
Study Subjects
Data were analyzed from a total of 205 newborn infants in this trial. Ninety-eight patients were randomly assigned to treatment with HFOV, and 107 patients to iNO (Fig. 1). Enrollments by disease category were as follows: RDS, n = 70; MAS, n = 58; “other,” n = 43; and CDH, n = 34. Cyanotic congenital heart disease (total anomalous pulmonary
Discussion
We found that treatment with HFOV plus iNO is more successful than HFOV or iNO alone in severe PPHN and that differences in responses are related to the specific disease associated with the complex disorders of PPHN. For patients with PPHN complicated by severe lung disease, response rates for HFOV plus iNO were better than HFOV alone or iNO with conventional ventilation. In contrast, for patients without significant parenchymal lung disease, both iNO therapy and HFOV-plus-iNO therapy were more
Acknowledgements
We gratefully acknowledge the support and contributions of Reese H. Clark, MD, Bradley A. Yoder, MD, Donald M. Null Jr., MD, J. Schmidt, RRT, J. Griebel, RRT, and L. Fashaw, RN.
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Cited by (0)
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Supported in part by National Institutes of Health grants HL41012 and 46481 (Dr. Abman); the General Clinical Research Centers Program (M01 RR00069), National Center for Research Resources; the March of Dimes Birth Defects Foundation (Dr. Kinsella); the American Heart Association Established Investigator Award (Dr. Abman); the Bugher Physician-Scientist Training Program (Dr. Kinsella); the Children’s Hospital Research Institute (Dr. Kinsella); the Hastings Foundation (Dr. deLemos), and the Children’s Mercy Hospital Physician Scientist Award (Dr. Truog).
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Reprint requests: John P. Kinsella, MD, Division of Neonatology, Box B-070, Children’s Hospital, 1056 E. 19th Ave., Denver, CO 80218-1088.
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0022-3476/97/$5.00 + 0 9/21/81929