Recombinant human deoxyribonuclease in infants with respiratory syncytial virus bronchiolitis.
BACKGROUND
Treatment of hospitalized infants with respiratory syncytial virus (RSV) bronchiolitis is mainly supportive. Bronchodilators and systemic steroids are often used but do not reduce the length of hospital stay. Because hypoxia and airways obstruction develop secondary to viscous mucus in infants with RSV bronchiolitis, and because free DNA is present in RSV mucus, we tested the efficacy of the mucolytic drug recombinant human deoxyribonuclease (rhDNase).


METHODS
In a multicenter, randomized, double-blind, controlled clinical trial, 225 oxygen-dependent infants admitted to the hospital for RSV bronchiolitis were randomly assigned to receive 2.5 mg bid of nebulized rhDNase or placebo until discharge. The primary end point was length of hospital stay. Secondary end points were duration of supplemental oxygen, improvement in symptom score, and number of intensive care admissions.


RESULTS
There were no significant differences between the groups with regard to the length of hospital stay (p = 0.19) or the duration of supplemental oxygen (p = 0.07). The ratio (rhDNase/placebo) of geometric means of length of stay was 1.12 (95% confidence interval, 0.96 to 1.33); for the duration of supplemental oxygen, the ratio was 1.28 (95% confidence interval, 0.97 to 1.68). There were no significant differences in the rate of improvement of the symptom score or in the number of intensive care admissions.


CONCLUSIONS
Administration of rhDNase did not reduce the length of hospital stay or the duration of supplemental oxygen in oxygen-dependent infants with RSV bronchiolitis.
Boogaard
Ruben
R
Department of Pediatric Pulmonology, Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherland. Electronic address: r.boogaard@erasmusmc.nl.
Hulsmann
Anthon R
AR
Department of Pediatrics, Amphia Hospital, Breda, Netherland.
van Veen
Leoniek
L
Reinier de Graaf Gasthuis, Delft, Netherland.
Vaessen-Verberne
Anja A P H
AAPH
Department of Pediatrics, Amphia Hospital, Breda, Netherland.
Yap
Yen Ni
YN
Albert Schweitzer Hospital, Dordrecht, Netherland.
Sprij
Arwen J
AJ
HagaTeaching Hospital/Juliana Children's Hospital, the Hague, Netherland.
Brinkhorst
Govert
G
Medisch Centrum Alkmaar, Alkmaar, Netherland.
Sibbles
Barbara
B
Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherland.
Hendriks
Tom
T
Catharina Hospital, Eindhoven, Netherland.
Feith
Sander W W
SWW
Sint Franciscus Gasthuis, Rotterdam, Netherland.
Lincke
Carsten R
CR
Medisch Centrum Rijnmond Zuid, Rotterdam, Netherland.
Brandsma
Annelies E
AE
Medisch Centrum Rijnmond Zuid, Rotterdam, Netherland.
Brand
Paul L P
PLP
Isala Klinieken, Zwolle, Netherland.
Hop
Wim C J
WCJ
Department of Epidemiology and Biostatistics, Erasmus MC, Rotterdam, the Netherlands, Netherland.
de Hoog
Matthijs
M
Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherland.
Merkus
Peter J F M
PJFM
Department of Pediatric Pulmonology, Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherland.
D000280:Administration, Inhalation; D001988:Bronchiolitis / Q000188:drug therapy*; D003850:Deoxyribonuclease I / Q000008:administration & dosage*; D004311:Double-Blind Method; D005100:Expectorants / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D015278:Intensive Care Units, Pediatric; D007902:Length of Stay; D008297:Male; D010102:Oxygen Inhalation Therapy; D010343:Patient Admission; D018357:Respiratory Syncytial Virus Infections / Q000188:drug therapy*; D018113:Respiratory Syncytial Virus, Human / Q000187:drug effects
D005100:Expectorants; C085693:DNASE1 protein, human; D003850:Deoxyribonuclease I