567
Participants
Start Date
October 7, 2015
Primary Completion Date
October 12, 2020
Study Completion Date
October 12, 2020
EcN-Suspension
"Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks).~Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day)."
Placebo
"Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks).~Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day)."
Klinikum Westbrandenburg, Potsdam
Klinikum Südstadt Rostock - Abteilung für Neonatologie, Rostock
Krankenhaus St. Elisabeth & St. Barbara, Halle
Universitätsklinikum Jena - Klinik für Kinder- und Jugendmedizin, Jena
"Oddział Kliniczny Noworodków, Wcześniaków z Intensywną Terapią Noworodka wraz z Wyjazdowym Zespołem N", Bydgoszcz
Samodzielny Publiczny Dziecięcy Szpital Kliniczny Oddział Kliniczny Neonatologiiul, Warsaw
Collaborators (1)
ICON plc
INDUSTRY
Clinscience Sp. z o.o.
UNKNOWN
Ardeypharm GmbH
INDUSTRY