| Detailed Summary of Surfactant Comparisons |
Morbidities |
| |
Study Characteristics |
Surfactants |
Primary Outcome |
Death - #/N (%) |
BPD - #/N (%) |
Severe IVH - #/N (%) |
PDA - #/N (%) |
| Bloom et al. [28] |
Prospective Randomized, Double-blind Multicenter Prophylaxis <29wk,<1250g |
- Calfactant (Surf A) (n=180, 891 ± 221g, 27.1 ± 2.2wk) - Beractant (Surf B) (n=194, 845 ± 205g, 27.1 ± 2.1wk) |
Calfactant group: spent fewer days on ventilator, fewer days on O2, but had more deaths in subgroup <600 g than Beractant group |
Surf A 25/180 (14) Surf B 16/194 (8) |
Surf A 59/180 (33) Surf B 60/194 (31) |
Surf A 9/180 (5) Surf B 10/194 (5) |
Surf A 94/180 (52) Surf B 107/194 (55) |
| Bloom et al. [28] |
Prospective Randomized, Double-blind Multicenter Treatment:
RDS <32 wks, <2 kg |
- Calfactant (Surf A) (n=303, 1162 ± 408g, 29 ± 2.8wk) - Beractant (Surf B) (n=305, 1166 ± 401g, 29 ± 2/9wk) |
Calfactant group: had lower mean airway pressure and FiO2 in first 3 days than Beractant group. |
Surf A 55/303 (18) Surf B 52/305 (17) |
Surf A 112/303 (37) Surf B 125/305 (41) |
Surf A 34/303 (11) Surf B 31/305 (10) |
Surf A 114/303 (38) Surf B 118/305 (39) |
| Bloom and Clark [29] |
Prospective Randomized, Double-blind Multicenter Prophylaxis <29 wk, <2 kg |
- Beractant (Surf A) (n=375, 907 ± 275g, 26.6 ± 1.9wk) - Calfactant (Surf B) (n=374, 910 ± 287g, 26.5 ± 2.0wk) |
Calfactant and Beractant groups had similar mortality, IVH, and NEC, but slow enrollment caused early study termination |
Surf A 45/375 (12) Surf B 49/374 (13) |
Surf A 128/375 (34) Surf B 128/374 (34) |
Surf A 18/375 (5) Surf B 11/375 (3) |
|
| Bloom and Clark [29] |
Prospective Randomized, Double-blind Multicenter Treatment, RDS on Vent, FIO2>40% |
- Beractant (Surf A) (n=673, 1154 ± 402g,28.4 ± 2.8wk) - Calfactant (Surf B) (n=688,1155 ± 408g, 28.4 ± 2.7wk) |
Calfactant and Beractant groups had similar mortality, IVH, and NEC, but slow enrollment caused early study termination |
Surf A 70/673 (10) Surf B 77/688 (11) |
Surf A 205/673 (30) Surf B 210/688 (31) |
Surf A 68/673 (10) Surf B 87/688 (13) |
|
| Speer et al. [39] |
Prospective Randomized, multicenter, 700-1500 g Treatment RDS on Vent, FIO2>40% |
- Poractant (Surf A) (n=33, 1095 ± 226g, 28.9 ± 2.3wk) - Beractant (Surf B) (n=40, 1084 ± 252g, 28.8 ± 2.2wk) |
Poractant reduced FiO2 and ventilatory requirements for >24 hours, vs. Beractant group. |
Surf A 1/33 (3.0) Surf B 5/40 (12.5) |
Surf A 4/33 (12.5) Surf B 5/40 (11.4) |
Surf A 1/33 (3.0) Surf B 5/40 (12.5) |
Surf A 18/33 (54.6) Surf B 12/40 (30.0) |
| Ramanathan et al. [42] |
Prospective Randomized, Multicenter, Double blind 750-1750g, <35 wks, subgroup <32 wks |
- Poractant, 100mg/kg (Surf A) (n=96, 1145 ± 365g, 28.9 ± 2.0wk) - Poractant 200 mg/kg (Surf B) (n=99, 1151 ± 259g, 28.6 ± 2.0wk) - Beractant 100 mg/kg (Surf C) (n=98, 1187 ± 273g, 28.7 ± 2.0wk) |
Poractant 100 and 200 mg/kg initial dose reduced FiO2, compared with Beractant group. Poractant 200 mg/kg intial dose had lower mortality vs. poractant 100 mg/kg or beractant groups. |
Subgroup <32 wks Surf A 9/85 (11) Surf B 3/95 (3) * Surf C 10/90 (11) |
Subgroup <32 wks Surf A 30/85 (35) Surf B 36/95 (38) Surf C 33/90 (37) |
Subgroup <32 wks Surf A 8/85 (9) Surf B 7/95 (7) Surf C 8/90 (9) |
Subgroup <32 wks Surf A 36/85 (42) Surf B 43/95 (45) Surf C 39/90 (43) |
| Baroutis et al (2003)43 |
Prospective Randomized 1 center, <32 wk, <2000 g , RDS on Vent |
- Alveofact (A), 100 mg/kg/dose (n=27, 1195 ± 390g, 29 ± 1.2wk) - Poractantvs(B),100 mg/kg/dose (n=27 1233 ± 380g, 28.7 ± 0.5wk) - Beractant (C) 100 mg/kg/dose (n=26, 1180 ± 410g, 29.2 ± 1wk) (Non-standard dosing regimen) |
Alveofact and Poractant groups: spent fewer days on ventilator, fewer days on O2, and spent fewer days in hospital than Beractant group. |
Surf A 7/27 (26) Surf B 5/27 (19) Surf C 6/26 (23) |
Surf A 3/27 (11) Surf B 4/27 (15) Surf C 4/26 (15) |
Surf A 5/27 (19) Surf B 6/27 (22) Surf C 4/26 (15) |
Surf A 5/27 (19) Surf B 4/27 (15) Surf C 5/26 (19) |
| Malloy et al. [44] |
Prospective Randomized Open Label, 1 center, RDS, Vent, <37 wk |
- Poractant (Surf A) (n=29, 1394 ± 699g, 29.6 ± 3.6wk) - Beractant (Surf B) (n=29, 1408 ± 534g, 29.3 ± 2.9wk) |
Poractant decreased FiO2 in the first 2 days and a fewer PDA's than in Beractant.group. |
Surf A 0/29 (0) Surf B 3/29 (10) |
Surf A 10/29 (34) Surf B 10/26 (37) |
Surf A 4/28 (14) Surf B 6/21 (21) |
Surf A 5/29 (17) Surf B 13/29 (45)* |
| Fujii et al. [45] |
Prospective Randomized Open Label
2 centers
RDS, Vent,
<30 wk |
- Poractant (Surf A) (n=25, 930 ± 231g, 27.1 ± 1.6wk) - Beractant (Surf B) (n=27, 900 ± 271g, 26.7 ± 1.7wk) |
Poractant decreased Mean Airway Pressures for 3 days, increased extubations at 2-3 days, and fewer PDA's than in Beractant group. |
Surf A 2/25 (8) Surf B 5/27 (19) |
Surf A 8/23 (35) Surf B 11/22 (50) |
Surf A 1/25 (4) Surf B 1/27 (4) |
Surf A 8/25 (32) Surf B 19/25 (76)* |
| Sinha et al. [44] |
Prospective Randomized multicenter, double blind, prophylaxis non-inferiority 24-28 wk, 600-1250 g |
- Lucinactant (Surf A) (n=119, 929 ± 189g, 27.0 ± 1.2wk) - Poractant (Surf B) (n=124, 937 ± 196g, 27.1 ± 1.4wk) (Non-standard dosing regimen) |
Lucinactant and Poractant were similar in efficacy and safety when used for the prevention and treatment of RDS. |
Surf A 19/119 (16) Surf B 23/124 (19) |
Surf A 23/100 (23) Surf B 18/101 (18) |
Surf A 46/119 (39) Surf B 47/124 (37) |
Surf A 51/119 (43) Surf B 54/124 (44) |
| Moya et al. [50] |
Randomized multicenter, double blind, RDS on Vent, <32 wk, 600-1250 g |
- Lucinactant (Surf A) (n=527, 974 ± 183g, 28.2 ± 1.9wk) - Colfosceril (Surf B) (n=509, 971 ± 186g, 28.2 ± 2.0wk) - Beractant (Surf C) (n=258 997 ± 187g, 28.1 ± 2.1wk) (Non-standard dosing regimen) |
Lucinactant more effective for RDS and BPD prevention than Colfosceril palmitate and decreased RDS mortality rates compared Beractant group. |
Surf A 111/527 (21) Surf B 124/509 (24) Surf C 68/258 (26)* |
BPD in all Enrolled Surf A 212/527 (40) Surf B 229/509 (45)* Surf C 109/258 (42) BPD in Survivors Surf A 212/416 (51) Surf B 229/385 (59)* Surf C 109/190 (57) |
Severe IVH/ PVL SurfA 115/527(22) SurfB 112/509(22) Surf C 55/258 (21) |
Surf A 195/527 (37) Surf B 188/509 (37) Surf C 95/258 (37) |
| Dizdar et al. [51] |
Randomized multicenter, RDS on Vent, <37 wk |
- Poractant (Surf A) (n=61, 1165 g (620-2290), 28 wk (25-36)
- Beractant (Surf B) (n=65, 1080 g (510-2750) , 28 wk (28-36) |
Poractant decreased multiple doses, increased early extubation, decreased, FIO2, and decreased BPD compared with beractant. |
Surf A 6/61 (10) Surf B 13/65 (20) |
BPD in all Enrolled Surf A 38/61 (58)
Surf B 48/65 (79)* |
Surf A 13/61 (22)
Surf B 9/65 (14) |
Surf A 33/65 (55)
Surf B 46/61 (71) |
