Treatment date | Country | Age Rx (hours) | FiO2 | Sex | BW (g) | GA (week) | Laboratory abnormalites | Initial MV | CPAP | Adverse events |
100 mg/kg cohort | ||||||||||
3 October 2012 | UK2 | 2 | 0.42 | M | 1505 | 30 | ↓Na ↑SBR | 22 hours | 6 days | |
24 January 2013 | UK2 | 24 | 0.57 | M | 1160 | 31 | ↑SBR | 5 hours | 5 days | |
16 February 2013 | UK1 | 5 | 0.38 | F | 900 | 27 | ↓Na ↑WCC | 3 hours | 39 days | |
1 March 2013 | UK1 | 4 | 0.70 | M | 1660 | 31 | ↑Na ↓K | 17 hours | 3 days | |
19 April 2013 | UK1 | 4 | 0.40 | F | 1010 | 28 | ↓Na | INSURE | 11 days | |
26 April 2013 | UK1 | 24 | 0.45 | F | 1270 | 30 | None | 21 hours | none | |
21 May 2013 | GER8 | 8 | 0.44 | M | 805 | 28 | ↓WCC ↑SBR ↑BG | 18 hours | 47 days | |
11 June 2013 | UK1 | 6 | 0.40 | F | 1243 | 31 | ↓Na ↓K | INSURE | 9 days | |
27 June 2013 | GER7 | 15 | 0.45 | F | 988 | 28 | ↑SBR | 1 day | 29 days | PDA |
29 June 2013 | UK6 | 4 | 0.36 | M | 1100 | 27 | None | 6 hours | 6 days | IVH day 5 PVL day 28. |
8 July 2013 | GER10 | 4 | 0.40 | M | 2250 | 33 | ↑SBR | 14 hours | 2 days | |
31 July 2013 | UK2 | 5 | 0.44 | F | 1995 | 32 | ↑CRP | 17 hours | none | |
20 September 2013 | UK1 | 9 | 0.36 | F | 832 | 28 | ↓Na | INSURE | 36 days | |
22 September 2013 | GER10 | 1 | 0.35 | M | 1490 | 32 | None | 16 hours | 3 days | Non-responder, PTX rescue Poractant x 2 |
18 October 2013 | GER8 | 37 | 0.45 | F | 1490 | 33 | ↑HR | 4 days | 6 days | SVT day 20 |
6 November 2013 | UK1 | 3 | 0.68 | M | 1140 | 28 | ↓Na | 8 hours | 23 days | PDA |
22 November 2013 | UK1 | 41 | 0.40 | M | 843 | 28 | ↓Na ↑SBR | 3 hours | 55 days | |
15 December 2013 | GER7 | 24 | 1.0 | M | 1371 | 29 | ↑SBR | 21 hours | 19 days | PDA |
8 January 2014 | UK1 | 10 | 0.36 | M | 1580 | 31 | ↓Na ↑SBR ↓plats | INSURE | 8 days | |
30 January 2014 | UK5 | 22 | 0.36 | F | 850 | 27 | None | 10 days | 53 days | PDA second dose Poractant day 5 |
200 mg/kg cohort | ||||||||||
21 February 2014 | GER7 | 2 | 0.50 | F | 1050 | 30 | ↑SBR | 12 hours | 3 days | Apnoeic episode |
23 March 2014 | CZE3 | 4 | 0.80 | M | 1100 | 27 | ↑SBR | 10 hours | 48 days | PDA |
12 April 2014 | UK6 | 4 | 0.75 | M | 1685 | 30 | ↓plats | 19 hours | 13 days | |
9 May 2014 | CZE4 | 3 | 0.50 | M | 1070 | 28 | ↑SBR | INSURE | 4 days | Apnoeic episode |
26 May 2014 | CZE4 | 26 | 0.38 | F | 1800 | 32 | None | INSURE | 4 days | |
27 May 2014 | CZE4 | 20 | 0.38 | F | 1075 | 27 | None | INSURE | 16 days | Episode of ET tube blockage, PDA |
1 June 2014 | CZE3 | 2 | 0.60 | F | 1590 | 30 | ↑SBR | INSURE | 5 days | |
1 June 2014 | CZE3 | 3 | 0.40 | F | 1490 | 30 | ↑SBR | INSURE | 4 days | |
25 June 2014 | CZE3 | 2 | 0.45 | M | 1130 | 28 | ↑SBR ↓Na | 40 mins | 26 days | |
26 June 2014 | CZE3 | 25 | 0.51 | M | 1060 | 28 | ↑SBR↓Na | INSURE | 26 days | |
27 June 2014 | GER10 | 5 | 0.60 | M | 975 | 28 | None | 14 hours | 12 days | PDA, PTX, second dose Poractant day 2, NEC day 13 - died |
28 July 2014 | UKe | 5 | 0.63 | M | 1690 | 33 | None | 20 hours | 1 day | |
29 August 2014 | UK5 | 5 | 0.55 | F | 870 | 27 | None | INSURE | 33 days | |
15 Septembert 2014 | CZE4 | 33 | 0.70 | F | 2080 | 32 | ↑SBR | INSURE | 4 days | |
26 September 2014 | UK1 | 13 | 0.36 | F | 876 | 31 | ↑SBR, ↓Na | INSURE | 8 days | |
26 September 2014 | CZE3 | 10 | 0.50 | M | 1306 | 30 | None | 1 hour | 12 days | |
21 October 2014 | CZE3 | 2 | 0.55 | M | 1720 | 31 | ↑SBR | 1 hour | 7 days | |
11 November 2014 | UK1 | 29 | 0.41 | M | 1688 | 30 | None | 23 hours | 7 days | |
18 November 2014 | UK6 | 5 | 0.48 | F | 2190 | 32 | None | 5 hours | 2 days | |
21 November 2014 | UK5 | 6 | 0.41 | F | 840 | 28 | None | 3 days | 41 days |
↓Na, hyponatraemia; ↓K, hypokalaemia; ↑SBR, hyperbilirubinaemia; ↑WCC, leucocytosis; ↓WCC, leucopenia; ↑BG, hyperglycaemia; ↑CRP, elevated C reactive protein; ↓plats, thrombocytopenia; ↑HR, tachycardia; PTX, pneumothorax; IVH, intraventricular haemorrhage; NEC, necrotising enterocolitis; PDA, patent ductus arteriosus; PVL, periventricular leucomalacia; SVT, supraventricular tachycardia; Column 2 shows sequence of recruitment by country and site. GER-Germany; CZE-Czech Republic. Site number according to instutions of authors. Age Rx, treatment age; FiO2, fraction of inspired oxygen required just prior to dosing; BW, birthweight; GA, gestational age; MV, mechanical ventilation; CPAP, continuous positive airways pressure; ET, endotracheal; INSURE, INtubation-SURfactant_Extubation