Author, year, and location Study design Timeline Study population Intervention strategy Sample size RSV hospitalization rates Conclusion Quality of study (1) Sorrentino and Powers, 2000, USA [33 ] Retrospective chart review 1998-1999 Premature infants with GA ≤ 35 weeks and age <2 years with CLD Palivizumab only 1839 Infants without CLD = 2.1%, with CLD = 4.0%, and with CF = 0% Hospitalization rates in prophylaxed children were similar to rates in prophylaxed children from IMpact-RSV trial [3 ] Low (2) Singleton et al., 2003, Alaska [26 ] Cohort study 1993–2001 Premature infants GA < 36 weeks Prepalivizumab era (1993–1996) versus postpalivizumab era (1998–2001) Prepalivizumab era: 992 Postpalivizumab era: 1087 Prepalivizumab era = 439/1000 births Palivizumab era = 150/1000 births ( ) The rate decreased by 3-fold with palivizumab Moderate (3) Pedraz et al., 2003, Spain [27 ] Cohort study 1998–2000 and 2000–2002 Premature infants with GA ≤ 32 without CLD and children aged <2 years with CLD Prepalivizumab era (1998–2000) versus postpalivizumab era (2000–2002) Nonprophylaxed group: 1583 Prophylaxed group: 1919 Infants ≤ 28 week GA: nonprophylaxed = 13%, prophylaxed = 5.4% ( ) Infants 29–32 week GA: nonprophylaxed = 9.9%, prophylaxed = 2.5%
( ) Infants with CLD: nonprophylaxed = 19.7%, prophylaxed = 5.5% ( ) Effective for children with GA ≤ 32 weeks and for children with CLD Moderate (4) Lacaze-Masmonteil et al., 2004, France [29 ] Cohort study 2000-2001 Premature infants with <33 week GA No palivizumab versus palivizumab Nonprophylaxed group: 2370 Prophylaxed group: 376 Nonprophylaxed = 20.1% Prophylaxed = 8.4% ( ) Protective benefits for infants with GA < 33 weeks Low (5) Parnes et al., 2003, USA [34 ] Record review 2000-2001 All children eligible for palivizumab according to AAP guidelines [40 ] Received at least one dose of palivizumab 2116 GA < 32 weeks: 986 (46.6%) GA 32– 35 weeks: 957 (45.2%) GA >35 weeks: 172 (8.1%) All infants = 2.9% Infants with CLD = 5.8% Infants < 32 weeks of GA = 4.5% Infants > 35 weeks of GA = 0.6% RSV hospitalization rates lower compared to rate of 13% in nonprophylaxed children from Spain [8 ] Low (6) Henckel et al., 2004, Sweden [30 ] Cohort study 1992–2002 Preterm infants with CLD and age < 2 years and extreme preterm infants No palivizumab versus Palivizumab Nonprophylaxed group: 61,990 Prophylaxed group: 235 Infants with CLD: nonprophylaxed = 6.8%, prophylaxed = 7.3% ( ) Infants with GA < 33 weeks: nonprophylaxed = 3.9%, prophylaxed = 2.7% ( ) Use of palivizumab may be restricted to very preterm infants (GA < 26 weeks) suffering from severe CLD Low (7) Singleton et al., 2006, Alaska [28 ] Cohort study 1994–1997 and 2001–2004 Premature infants GA < 36 weeks Prepalivizumab era (1994–1997) versus postpalivizumab era (2001–2004) 2555 children Prepalivizumab era = 317/1000 births/year Palivizumab era = 123/1000 births/year ( ) Palivizumab reduced hospitalization rate in premature infants Low (8) Mitchell et al., 2006, Canada [23 ] Cohort study 1995–2002 All premature infants Prepalivizumab era (1995–1998) versus postpalivizumab era (1999–2002) (in Calgary palivizumab was introduced in 1999 whereas in Edmonton palivizumab was not administered) Calgary: 2,876 GA 33–35 weeks: prepalivizumab era: 907, postpalivizumab era: 842 GA < 33 weeks or with CLD: prepalivizumab era: 411, postpalivizumab era: 496 Edmonton: 2,467 GA 33–35 weeks: prepalivizumab era: 787, postpalivizumab era: 834 GA < 33 weeks or with CLD: prepalivizumab era: 401, postpalivizumab era: 425 Edmonton = 7.1% Calgary = 2.9% ( ) Calgary Infants with GA < 33 weeks or GA 33–35 weeks with CLD: prepalivizumab era = 7.3%,
postpalivizumab era 3.0% ( ) Infants with GA 33–35 weeks and born within 6 months of RSV season or at the start of RSV season: prepalivizumab era = 3.3%,
postpalivizumab era = 2.7% ( ) Edmonton Infants with GA < 33 weeks or GA 33–35 weeks with CLD: prepalivizumab era = 5.0%, postpalivizumab era = 7.0% ( ) Infants with GA 33–35 weeks: prepalivizumab era = 4.1%, postpalivizumab era = 2.1% ( ) Effective for infants with GA < 33 weeks with other comorbidities Could be upgraded to moderate Moderate (9) Kusuda et al., 2006, Japan [25 ] Nonrandomised questionnaire survey 2002-2003 All premature infants born at GA ≤ 35 weeks and infants with CLD No palivizumab versus palivizumab Nonprophylaxed group: 41 Prophylaxed group: 35 Nonprophylaxed group = 1.3% Prophylaxed group = 1.4% Small sample size to determine conclusive result Very low (10) Grimaldi et al., 2007, France [31 ] Cohort study 1999–2004 Premature infants with GA ≤ 30 weeks without BPD Prepalivizumab era (1999–2002) versus postpalivizumab era (2002–2004) Prepalivizumab era: 118 Postpalivizumab era: 88 Prepalivizumab era = 13.5% Postpalivizumab era = 1.1% ( ) Palivizumab reduced hospitalization rate Low (11) Chang et al., 2010, Korea [36 ] Hospital record review 2004–2009 Children were born at ≤35 weeks of GA, were <2 years of age, and had received medical therapy for CLD No palivizumab versus palivizumab Nonprophylaxed group: 53 Prophylaxed group: 75 Nonprophylaxed group = 22.6% Prophylaxed group = 4.0% ( ) Palivizumab reduced RSV hospitalization in children with CLD Low (12) Paes et al., 2012, Canada [35 ] Cohort study 2006–2011 Group 1: premature infants GA ≤ 32 weeks without preexisting medical disorders Group 2: premature infants GA 33–35 completed weeks Comparison between prophylaxed Group 1 and prophylaxed Group 2 Group 1: 5,183 Group 2: 1,471 Group 1 = 1.5% Group 2 = 1.4% ( ) Palivizumab prophylaxis beneficial for infants with 33–35 week GA but should be country-specific Low