Table 1. Characteristics of placebo randomized controlled trials registered in ClinicalTrials.gov (1999–2015).

	N	%
TOTAL NUMBER OF TRIALS	146	100.0
NEONATES STUDIED
Preterm	70	47.9
Term	35	24.0
Preterm and Term	41	28.1
NUMBER OF PATIENTS PLANNED
0–50	35	24.6
51 to 100	42	29.5
>100	65	45.7
unknown	4	0.2
SPONSOR (N)
Industry	21	14.4
Government*	22	15.0
Non-federal/Non-profit1	81	55.5
Government+Industry	2	1.4
Non-federal/Non-profit+ Industry	9	6.2
Non-federal/Non-profit+Government	10	6.8
Non-federal+Industry+Governement	1	0.7
STUDY PHASES
Phases 1 and 1/2	21	14.4
Phases 2 and 2/3	57	39.0
Phase 3	40	27.4
Phase 4	28	19.2
BLINDING
Blinded	144	98.6
Open label	2	1.4
LOCATION (N)
SINGLE CENTER	81	55.5
Africa	2	2.5
Middle East Asia	22	27.2
Europe	18	22.2
North America	35	43.2
South America	4	4.9
Oceania	0	0
MULTICENTER NATIONAL TRIALS	43	29.5
Europa	4	9.3
North America	38	88.4
Asia	1	2.3
MULTICENTER INTERNATIONAL TRIALS	10	6.8
Africa	1	10.0
Middle East Asia	3	30.0
Europe	10	100.0
North America	5	50.0
South America	1	10.0
Oceania	2	20.0
UNKNOWN	12	8.2
RECRUITMENT STATUS2
Open—recruiting	21	14.4
Open—not recruiting	15	10.3
Completed	91	62.3
Unknown	19	13.0
LENGHT OF STUDY (as planned—years)
<1	40	27.4
1–2	56	38.4
3–4	25	17.1
>4	25	17.1
Unknown	0	0.0
PUBLICATION*2
Yes	58	39.7
Patients reported in the publication versus planned in the trial
± 10% of planned	35	24.0
More than 10% higher	15	10.2
More than 10% lower	8	5.5
No	88	60.3

* GOVERNMENT = all the Governmental Institutions + US Federal Agency + NIH (National Institute of Health)

¹ NON-FEDERAL = University+ Organization+ Hospital+ Clinical Research Network

² Updated in December 2017