Effectiveness of ribavirin in otherwise well infants with respiratory syncytial virus-associated respiratory failure☆,☆☆,★,★★

Presented in part at the Society of Critical Care 24th Annual Educational and Scientific Symposium, San Francisco, Calif., Jan. 31 to Feb. 4, 1995, and published in abstract form (Crit Care Med 1995;23:A225).
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Abstract

OBJECTIVE: To examine ribavirin's effectiveness in otherwise well infants with respiratory syncytial virus (RSV)–associated respiratory failure. DESIGN: Prospective multicenter cohort study. SETTING: Pediatric critical care units affiliated with the Pediatric Critical Care Study Group; 38 centers from the United States and Canada participated. PATIENTS: Infants with RSV-associated respiratory failure undergoing mechanical ventilation. INTERVENTIONS: NONE. MEASUREMENTS AND MAIN RESULTS: Data collected included demographic information; dates of hospitalization, intensive care, and mechanical ventilation; all patient diagnoses; reason for tracheal intubation; dates of ribavirin use before and during mechanical ventilation; time in hours after intubation until ribavirin administration; Pediatric Risk of Mortality (PRISM) score; and outcome. A total of 439 patients received mechanical ventilation for RSV-associated respiratory failure; 223 were classified as previously well and met entry criteria. Ninety-one infants (41%) received ribavirin during mechanical ventilation. The PRISM scores during the initial 24 hours of intensive care and blood gas measurements before intubation were similar for patients who received ribavirin versus those who did not. Use of ribavirin during mechanical ventilation was associated with prolonged duration of mechanical ventilation (p <0.01) in a multivariate model that controlled for patient age, gender, prematurity status, and use of ribavirin before intubation. Subgroup analysis of mechanical ventilation days for previously well patients was 5.0 ± 4.2 in the no-ribavirin group versus 6.4 ± 5.0 in the ribavirin group (p <0.05) and for well premature infants was 6.3 ± 4.9 in the no-ribavirin group versus 9.0 ± 6.3 in the ribavirin group (p <0.01). The mortality rates for the term and the premature groups were similar for treated and untreated patients. CONCLUSIONS: Ribavirin administration during mechanical ventilation to previously well infants with RSV infection was not associated with reductions in either mortality rates or duration of mechanical ventilation. Additional clinical effectiveness studies are required to define specific groups in which the use of aerosolized ribavirin is indicated. (J PEDIATR 1996;128:422-8)

Section snippets

Pediatric Critical Care Study Group

The Pediatric Critical Care Study Group is a consortium of pediatric intensive care units, developed through the pediatric section of the Society of Critical Care Medicine, committed to the facilitation of clinical research to improve the care of critically ill children. Each participating institution is represented by a single principal investigator who is responsible for study data collection. All sponsored projects have been formally reviewed and approved by the protocol review committee and

RESULTS

A total of 439 data records of patients with RSV-associated respiratory failure were completed for this study. Two hundred twenty-three patients were categorized as previously well and met entry criteria; 219 patients survived and 4 patients died (Table I). Ninety-one patients (41%) received ribavirin during mechanical ventilation. The mean time from initiation of mechanical ventilation until ribavirin administration was 14.9 ± 13.6 hours (median 12 hours; range, 0 to 60). Of the 91 patients

DISCUSSION

Despite recommendations from the American Academy of Pediatrics Committee on Infectious Disease,1 ribavirin is often not administered to patients in whom its use has been recommended.26, 27 Ribavirin was initially approved for use in non-intubation-supported infants after reports of a high mortality rate for RSV disease in patients with congenital heart disease28 and randomized, masked clinical trials that demonstrated improvement in some clinical scores or oxyhemoglobin saturation when

Acknowledgements

Participating investigators and centers are as follows: Robert J. Adderley, MD, British Columbia's Children's Hospital, Vancouver, British Columbia, Canada; Sana Al-Jundi, MD, Children's Hospital of Orange County, Orange, Calif.; Harold Amer, MD, Cedars-Sinai Medical Center, Los Angeles, Calif.; Jeffrey L. Blummer, MD, PhD, Rainbow Babies and Childrens Hospital, Cleveland, Ohio; Susan Bratton, MD, Children's Hospital and Medical Center, Seattle, Wash.; Cynthia Broner, MD, Children's Hospital,

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    ☆

    From the Department of Pediatrics and Communicable Diseases and the School of Public Health, University of Michigan, Ann Arbor; the Department of Pediatrics, Medical Collage of Georgia, Augusta; and the Department of Pediatrics, University of Tennessee, Memphis

    ☆☆

    aParticipating investigators and centers are listed above the references.

    ★

    Reprint requests: Frank W. Moler, MD, MS, Pediatric Critical Care, F-6884 Mott/0243, 1500 E. Medical Center Dr., University of Michigan Hospitals, Ann Arbor, MI 48109-0243.

    ★★

    0022-3476/96/$5.00 + 0 9/25/70274

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