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Controlled trial of continuous negative external pressure in the treatment of severe respiratory distress syndrome
Fanaroff AA, Cha CC, Sosa R, Crumrine RS, Klaus MH
The Journal of Pediatrics 1973 Jun;82(6):921-928
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

A sequential controlled trial of continuous negative pressure versus oxygen in treatment of severe respiratory distress syndrome (PaO2 < 60 mmHg in FiO2 70% or greater) was performed. CNP was applied by means of a newly designed, inexpensive plastic chamber. Twenty-nine infants with RDS who weighed > 1,000 Gm. and who had no congenital malformations were studied; there were 14 in the oxygen-treated control group and 15 in the CNP-treated group. Following the study, seven additional infants were treated with CNP. Birth weights, sex, gestational ages, ages, and blood gases at the time of admission to the study were similar. Study failure was defined as PaO2 < 50 mmHg in 100% oxygen, or onset of apnea. Sequential analysis revealed CNP was superior to oxygen (p < 0.05): study successes-CNP group, 10 of 15 (67%) and oxygen-treated control group, 2 of 14 (14%). CNP improves oxygenation in RDS and significantly reduces duration of exposure to high oxygen concentration and the need for respiratory therapy. The over-all survival rate was 72%.

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