Table 2.
Prospective, comparative studies on the effectiveness of palivizumab prophylaxis in reducing RSVH
| Author | RCT | Study design | Study population | RSVH (%) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Preterm < 29 wGA | Preterm 29-32 wGA | Preterm 32-35 wGA | Preterm ≤ 35 wGA | ||||||||
| Untreated | Prophylax | Untreated | Prophylax | Untreated | Prophylax | Untreated | Prophylax | ||||
| IMpact-RSV Study [61, 78] US, UK, Canada | + | Multicenter, randomized, double-blind, placebo-controlled | 1502 children with prematurity (≤ 35 wGA) or BPD | 10.0 | 2.0a | 7.7 | 1.6b | 10.1 | 1.8b | 8.1 | 1.8c |
| Pedraz [65] Spain | − | Multicenter, comparing 2 untreated cohorts to 2 prophylaxed cohorts | 3502 preterm infants ≤ 32 wGA (11.3% CLD [prophylaxed cohort]; 4.8% CLD [non-prophylaxed cohort]) | 13.0 | 5.4d | 9.9 | 2.5d | 10.4f | 3.7ef | ||
| Blanken (MAKI) [25] Netherlands | + | Multicentre, randomized, double-blind, placebo-controlled | 429 otherwise healthy infants 33-35 wGA | 5.1 | 0.9m | ||||||
|
Figueras-Aloy [66] Spain |
− | Multicenter, 2-cohort | 5441 preterm infants 32–35 wGA (excluded CHD and other serious comorbidities) | 4.1 | 1.3c | ||||||
| Faldella [64] Italy | − | Single center follow-up of infants admitted to NICU soon after birth | 225 preterm infants ≤ 32 wGA | 9.9h | 1.9g | ||||||
| Grimaldi [67, 72] France | − | Burgundy region, comparing untreated cohorts to prophylaxed cohorts over up to 5 RSV seasons |
69 preterm infants ≤ 32 wGA with BPD (included 2 infants with CHD) 339 preterm infants ≤ 30 wGA without BPD (included 9 infants with CHD) |
0.2–16.7j | 0–2.0ij | ||||||
| Feltes [80] USA | + | Multicenter, randomized, double-blind, placebo-controlled | 1287 children aged ≤ 24 months old with HS-CHD | ||||||||
| Medrano López [81] Spain | − | Multicenter, epidemiologic, covering 4 RSV seasons | 2613 children ≤ 24 months old with HS-CHDp | ||||||||
| Weighted mean rate [95% CI] | 12.5 [11.5–13.5] | 4.8 [4.1–5.4] | 9.5 [8.7–10. 4] | 2.4 [1.9–2.8] | 4.8 [4.2–5.2] | 1.4 [1.1–1.6] | 9.1–10.2 [8.1–9.6; 9.3–11.0] | 2.9–3.0 [2.3–3.2; 2.5–3.4] | |||
| Author | RCT | Study design | Study population | RSVH (%) | |||||
|---|---|---|---|---|---|---|---|---|---|
| CLD/BPD | CHD | Preterm and CHD/BPD/other comorbidities | |||||||
| Untreated | Prophylax | Untreated | Prophylax | Untreated | Prophylax | ||||
| IMpact-RSV Study [61, 78] US, UK, Canada | + | Multicenter, randomized, double-blind, placebo-controlled | 1502 children with prematurity (≤ 35 wGA) or BPD | 12.8 | 7.9b | ||||
| Pedraz [65] Spain | − | Multicenter, comparing 2 untreated cohorts to 2 prophylaxed cohorts | 3502 preterm infants ≤ 32 wGA (11.3% CLD [prophylaxed cohort]; 4.8% CLD [non-prophylaxed cohort]) | 19.7 | 5.5g | 13.25 | 3.95e | ||
| Blanken (MAKI) [25] Netherlands | + | Multicentre, randomized, double-blind, placebo-controlled | 429 otherwise healthy infants 33-35 wGA | ||||||
|
Figueras-Aloy [66] Spain |
− | Multicenter, 2-cohort | 5441 preterm infants 32–35 wGA (excluded CHD and other serious comorbidities) | ||||||
| Faldella [64] Italy | − | Single center follow-up of infants admitted to NICU soon after birth | 225 preterm infants ≤ 32 wGA | ||||||
| Grimaldi [67, 72] France | − | Burgundy region, comparing untreated cohorts to prophylaxed cohorts over up to 5 RSV seasons |
69 preterm infants ≤ 32 wGA with BPD (included 2 infants with CHD) 339 preterm infants ≤ 30 wGA without BPD (included 9 infants with CHD) |
46.2 | 3.8–11.8i | ||||
| Feltes [80] USA | + | Multicenter, randomized, double-blind, placebo-controlled | 1287 children aged ≤ 24 months old with HS-CHD | 9.7 (cyanotic: 7.9) (other [acyanotic]: 11.8) | 5.3b (cyanotic: 7.9n) (other [acyanotic]: 11.8o) | ||||
| Medrano López [81] Spain | − | Multicenter, epidemiologic, covering 4 RSV seasons | 2613 children ≤ 24 months old with HS-CHDp | 7.9 | 3.3i | ||||
| Weighted mean rate [95% CI] | 17.6 [16.5–18.6] | 6.2 [5.5–6.9] | 8.5 [7.6–9.4] | 4.0 [3.3–4.6] | 13.9 [12.7–14.9] | 4.0-4.1 [3.3–4.6; 3.5–4.8] | |||
BPD bronchopulmonary dysplasia, CHD congenital heart disease, CI confidence interval, CLD chronic lung disease, HS-CHD hemodynamically significant congenital heart disease, RCT randomized controlled trial RSVH respiratory syncytial virus hospitalization, wGA weeks’ gestational age
aNon-significant vs. untreated
bP < 0.05 vs. untreated
cP < 0.001 vs. untreated
dP < 0.0001 vs. untreated
eSignificance not reported
f≤ 32 wGA
gP < 0.007 vs. untreated
h≤ 32 wGA hospitalized for respiratory tract infection during the RSV season
iP < 0.01 vs. untreated
j≤ 30 wGA
kP = 0.003 vs. untreated
lEvaluated adequate (full course) vs. inadequate (incomplete) prophylaxis
mP = 0.01 vs. placebo (infants 33–35 wGA)
nP = 0.285; cyanotic included: pulmonary atresia with ventricular septal defect, pulmonary atresia with intact septum, tetralogy of Fallot, single ventricle including hypoplastic left or right heart, tricuspid atresia, double-outlet right ventricle with transposed great arteries, Ebstein anomaly, or D-transposition of the great arteries with/without ventricular septal defect, with/without pulmonary stenosis
oP = 0.003; other (acyanotic) included remaining children not stratified as having cyanotic CHD
pHS-CHD defined as: heart failure clinic, malnutrition (weight percentile < 3 for age and sex), hypoxemia (desaturation, need for supplementary O2) and/or requiring cardiac medication [82]