Table 2

Patient sequence, individual characteristics, adverse events and outcomes

Treatment date	Country	Age R_x (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	UK	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 R_x, treatment age; FiO_2, 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