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Comment on “A new device for administration of continuous positive airway pressure in preterm infants” by Trevisanuto et al

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Intensive Care Med (2005) 31:1732–1733 DOI 10.1007/s00134-005-2840-9 P E D I A T R I C C O R R E S P O N D E N C E Pierantonio Santuz Massimo Soffiati Monica Benedetti Paolo Biban

Comment on “A new device for administration

of continuous positive airway pressure

in preterm infants” by Trevisanuto et al.

Accepted: 23 September 2005 Published online: 9 November 2005  Springer-Verlag 2005

This reply refers to the article http:// dx.doi.org/10.1007/s00134-005-2839-2

P. Santuz (

)

) · M. Soffiati · M. Benedetti · P. Biban

Neonatal and Pediatric Intensive Care Unit, Department of Pediatrics,

Major City Hospital,

Azienda Ospedaliera di Verona, Piazzale Stefani 1, 37126 Verona, Italy e-mail: pierantonio.santuz@azosp.vr.it Tel.: +39-045-8072377

Fax: +39-045-8073481

Sir: we read with interest the contri-bution by Trevisanuto et al. [1] on the effectiveness of a new device for administering continuous positive airway pressure (CPAP) as an alter-native to conventional nasal CPAP in ameliorating comfort in preterm in-fants needing continuous distending pressure. The data which they present are intriguing, but a few points need to be further discussed. First, the use of a “comfort scale” appears to be a surrogate end-point. To properly as-sess safety and efficacy of this new technique, even in a pilot study, the authors should have focused on more relevant clinical aspects or potential complications, such as level of res-piratory distress, oxygen-dependen-cy, rate of apnea, local damage, air leak, or need for mechanical ventila-tion.

Second, the authors reported a marked reduction in the Neonatal Infant Pain Scale (NIPS) values, i.e., a better comfort status of patients, during treatment with helmet CPAP. Given the lower level of stress im-posed by this technique, one might have expected some modifications in the main physiological parameters, such as heart rate, respiratory rate, and arterial blood pressure [2]. On the other hand, none of the investigated parameters differed between the two CPAP treatments, raising doubts about potential bias due to the non-blinded scoring method used in this study. Indeed, NIPS does require a

close observation of the infant, mak-ing any blindmak-ing process quite com-plex. Such important limitation might be partially circumvented by simul-taneous NIPS measurements per-formed by two independent observers or by video recording.

Third, the small number of en-rolled patients (powered only for the chosen end-point), the very brief du-ration of both CPAP treatments, and the relatively healthy status of the population studied preclude any de-finitive conclusion about this study. Indeed, how would this technique work in sicker infants who may re-quire CPAP continuously for days or weeks? What are the possible effects of long-term application on abdomi-nal distension, or in the prevention of apnea episodes?

As regards the latter point, we have had the contrary findings in a single preliminary experience. A premature infant (31weeks of post-conceptional age) treated with con-ventional nasal CPAP (Infant-Flow-Driver, EME) for apnea of prematu-rity, was shifted to helmet CPAP due to poor tolerance of nasal prongs. However, after 2 h of treatment he had to be returned to nasal CPAP for repeated episodes of apnea and arte-rial O2desaturation. Interestingly, as

soon as conventional nasal CPAP was applied, the apneic episodes virtually disappeared. Of note, we report some difficulties in maintaining CPAP levels above 3 cmH2O, despite flow

(2)

1733

rates set as high as 15 lpm and ab-sence of major leaks in the system. We speculate that conventional nasal CPAP, successfully used for apnea of prematurity [3], would be more ef-fective than the new technique in these circumstances.

In summary, we congratulate the authors for their original study. Nonetheless, their conclusion that the helmet CPAP “seems to guarantee a better tolerability and at least similar improvement in oxygenation” may be

misleading for the reader. We believe that larger randomized controlled studies are needed to better define the role of this new device and to verify its potential superiority over conven-tional CPAP by means of more ap-propriate end-points.

References

1. Trevisanuto D, Grazzina N, Doglioni N, Ferrarese P, Marzari F, Zanardo V (2005) A new device for administration of continuous positive airway pressure in preterm infants: comparison with a standard nasal CPAP continuous posi-tive airway pressure system. Intensive Care Med 31:859–864

2. Di Maggio TJ, Gibbons MA (2005) Neonatal pain management in the 21st century. In Taeusch HW, Ballard RA, Gleason GA (ed) Avery’s diseases of the newborn. Elsevier Saunders, Philadelphia, pp 438–446

3. De Paoli AG, Davis PG, Faber B (2002) Devices and pressure sources for ad-ministration of nasal continuous posi-tive airway pressure (NCPAP) in preterm neonates. Cochrane Library, issue 4, Oxford

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