[2005] [712] Delayed Prophylaxis in Children at High Risk for RSV Disease
M. E. Speer, M. Boron, K. McLaurin, A. Cohen, M. Rankin, Palivizumab Outcomes Registry Group. Pediatrics, Baylor College of Medicine, Houston, TX; Medical Affairs, MedImmune, Inc., Gaithersburg, MD; The EMMES Corporation, Rockville, MD.
BACKGROUND: 2003 American Academy of Pediatrics (AAP) guidelines recommend RSV prophylaxis with palivizumab be given 48-72 hours before discharge during the RSV season for hospitalized infants considered to be at risk for severe disease and continue with monthly doses for the remainder of the season.
OBJECTIVE: The Outcomes Registry is a multicenter study designed to prospectively collect data on children receiving RSV prophylaxis over four seasons (2000-04). We describe doses received by infants discharged from neonatal intensive care units (NICU).
DESIGN/METHODS: Infants to be discharged from the NICU after October 1st during each season were identified as potential candidates for RSV prophylaxis before discharge. Dates of initial palivizumab injections were recorded, either as hospital or outpatient (Otpt) doses.
RESULTS: Potential candidates for initial hospital doses ranged from 38% to 14% of enrollees over the three seasons (Table). Over the study period the percentage of infants receiving first dose before hospital discharge decreased from 67% to 43%. On average, infants received their first dose 29 days after discharge. Of infants not receiving first dose before discharge, 29% were < 32 wks GA.
CONCLUSIONS: Although revised guidelines recommend RSV prophylaxis prior to NICU discharge, fewer infants appear to be receiving doses before discharge to home. Additionally, a significant delay occurs before infants receive first palivizumab doses in the outpatient setting. Speculation: Delay in the administration of palivizumab may result in unnecessary hospitalization from RSV.
Receipt of NICU and Outpatient Doses| Registry Season | 2000-01 | 2001-02 | 2002-03* | 2003-04 | | Enrollees | 2,116 | 5,091 | 6291 | 6,050 | | Potential Candidates for NICU Dose | 786 (38%) | 1482 (27%) | 935 (15%) | 829 (14%) | | Of Potential Candidates: | | 1st Dose Received in NICU | 489 (67%) | 850 (57%) | 352 (38%) | 357 (43%) | | 1st Dose Received in Otpt | 297 (38%) | 632 (43%) | 574 (61%) | 472 (57%) | | Days to 1st Otpt Dose (mean) | 32 | 30 | 27 | 28 | | Days to 1st Otpt Dose (median) | 25 | 26 | 25 | 26 | | Range of days to receipt | 1-142 | 1-124 | 1-74* | 0-122 | *Enrollment completed early, December 2003
Employee of MedImmune, Inc.; Investigators in the Synagis Outcomes Registry.
PAS 2005: 57: 712
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