Abstract | BACKGROUND: This is the first report about a prospective clinical investigation to study the efficacy and safety of nitric oxide (NO) inhalation in infants with persistent pulmonary hypertension of the newborn (PPHN) in Japan. METHODS: Patients in the present study had to meet the following entry criteria: (i) they had to be younger than 7 days of age; (ii) they had to have evidence of PPHN as defined by echocardiograph; (iii) they had to have severe systemic hypoxemia under mechanical ventilation at 100% oxygen supplementation; and (iv) they had to have a failure to respond to conventional therapies. Patients were excluded from this trial if they had any of the following: hypoplastic lung, structural cardiac lesions or severe multiple anomalies. RESULTS: CONCLUSIONS: These results may be valuable for further randomized controlled and double-blind trials in Japan to evaluate whether NO inhalation therapy is more effective than conventional therapy in infants with severe PPHN.
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Authors | N Yamaguchi, H Togari, M Takase, S Hattori, S Yamanami, H Hasegawa, R Hoshino, M Tamura, S Mimura, S Suzuki, M Futamura, H Aotani, K Sumi, S Kusuda, H Ichiba, L Yong-Kye, Y Uetani, H Nakao, R Higuchi |
Journal | Pediatrics international : official journal of the Japan Pediatric Society
(Pediatr Int)
Vol. 43
Issue 1
Pg. 20-5
(Feb 2001)
ISSN: 1328-8067 [Print] Australia |
PMID | 11207994
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
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Topics |
- Administration, Inhalation
- Humans
- Infant, Newborn
- Japan
- Nitric Oxide
(administration & dosage, adverse effects)
- Oxygen
(blood)
- Persistent Fetal Circulation Syndrome
(drug therapy)
- Prospective Studies
- Treatment Outcome
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