Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies

PHASE3CompletedINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

May 29, 2005

Primary Completion Date

March 16, 2008

Study Completion Date

July 17, 2015

Conditions
Lung Disease
Interventions
DRUG

Nitric oxide

Nitric Oxide vapour (gas) for inhalation (400 ppm)

DRUG

Placebo

Placebo gas for inhalation

Trial Locations (35)

10117

Campus Charite Mitte, Berlin

24128

Ospedali Riuniti, Bergamo

28007

Hospital Universitario Gregorio Mar, Madrid

28046

Hosspital Univeritario La Paz, Madrid

35033

Universitaetsklinikum Marburg, Marburg

35128

University Padova, Padua

38320

Hospital Universitario Canarias, Santa Cruz de Tenerife

40138

Policlinico S. Orsola, Bologna

41013

Hospital Universitario Virgen del Rocio, Seville

44093

Hospital Mere-Enfant, Nantes

46009

Hospital Universitario La Fe, Valencia

48903

Hospital de Cruces, Barakaldo

50134

Azienda Ospedaliera Careggi, Florence

60123

Az. Osp. G. Salesi, Ancona

68167

Universitaetsklinikum Mannheim, Mannheim

69115

Universitaetsklinikum Heidelberg, Heidelberg

72076

Universitaeklinikum Tuebingen, Tübingen

75019

Hospital Robert Debre, Paris

81377

Universitaetsklinikum Muenchen, München

89075

Univeritaetsklinik Ulm, Ulm

94000

Centre Hospitalier Intercommunal de Creteil, Créteil

Unknown

UCL St. LUC, Brussels

Clinique Notre Dame, Charleroi

Universitair Ziekenhuis Antwerpen, Edegem

Clinique St. Vincent CHC, Rocourt

FI-90220

Oulun yliopsistollinen sairaala, Oulu

00168

Policlinico Gemelli, Roma

9713 GZ

Beatrix Children's Hospital, University Medical Center Groningen, Groningen

3000 CB

Sophia Kinderziekenhuis, Rotterdam

08035

Hospital Universitario Vall d'Hebron, Barcelona

SE-171 76

Astrid Lindgrens barnsjukjus, Karolinska Unviersritets sjukhuset-Solna, Stockholm

SE-751 85

Akademiska Sjukhuset, Uppsala

ME7 5NY

Meedway Mariton Hospital, Gillingham

LE1 5WW

Leicester Royal Infirmary, Leicester

SE5 9RS

Kings College, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY

NCT00551642 - Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies | Biotech Hunter | Biotech Hunter