A randomised control study comparing the Infant Flow Driver with nasal continuous positive airway pressure in preterm infants
M Mazzellaa, C Bellinia, M G Calevob, F Camponea, D Massoccoa, P Mezzanoa, E Zullinoa, F Scopesia, C Arionia, W Bonaccia, G Serraa
a Department of
Pediatrics, Neonatal Intensive Care Unit, G Gaslini Institute,
University of Genova, Genova, Italy, b Service of Biostatistics and
Epidemiology, G Gaslini Institute
Correspondence to: Dr Mazzella, Department of Pediatrics, Neonatal Intensive Care Unit, G Gaslini Institute, University of Genova, Largo Gerolamo Gaslini 5, 16148 Genova, Italy massimomazzella{at}ospedale-gaslini.ge.it
Accepted 3 April 2001
OBJECTIVE
To compare
the effectiveness of the Infant Flow Driver (IFD) with single prong
nasal continuous positive airway pressure (nCPAP) in preterm neonates
affected by respiratory distress syndrome.
DESIGNRandomised
controlled study.
PATIENTSBetween
September 1997 and March 1999, 36 preterm infants who were eligible for
CPAP treatment were randomly selected for either nCPAP or IFD and
studied prospectively for changes in oxygen requirement and/or
respiratory rate. The requirement for mechanical ventilation,
complications of treatment, and effects on mid-term outcome were also evaluated.
RESULTSUse of the IFD
had a significantly beneficial effect on both oxygen requirement and
respiratory rate (p < 0.0001) when compared with nCPAP. Moreover,
O2 requirement and respiratory rate were significantly
decreased by four hours (p < 0.001 and p < 0.03 respectively).
The probability of remaining supplementary oxygen free over the first
48 hours of treatment was significantly higher in patients treated with
the IFD than with nCPAP (p < 0.02). IFD treated patients had a
higher success (weaning) rate (94% v 72 %)
and shorter duration of treatment (49.3 (31)
v 56 (29.7) hours respectively; mean (SD)),
although the difference was not significant.
CONCLUSIONSIFD
appears to be a feasible device for managing respiratory distress
syndrome in preterm infants, and benefits may be had with regard to
oxygen requirement and respiratory rate when compared with nCPAP. The
trend towards reduced requirement for mechanical ventilation, shorter
clinical recovery time, and shorter duration of treatment requires
further evaluation in a multicentre randomised clinical trial.
Keywords: Infant Flow Driver; continuous positive airway pressure; preterm; respiratory distress syndrome
© 2001 by Archives of Disease in Childhood
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