TINN2: Treat Infections in Neonates 2

Phase 1

Conditions: Bronchopulomary dysplasia
MedDRA version: 18.0Level: PTClassification code 10006475Term: Bronchopulmonary dysplasiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.0Level: LLTClassification code 10066204Term: Chronic lung disease of prematuritySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2013-003889-14-GB

Lead Sponsor: Institut National de la Santé et de la Research Médicale

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 810

Inclusion Criteria

a) Pre-term, =28 weeks gestational age (i.e. 28 weeks and 6 days, including infants born as one of a multiple birth)
b) Requirement for respiratory support within 12hrs of birth (intubated, or by non-invasive mechanical ventilation inc. continuous positive airway pressure)
c) Presence of an indwelling intravenous line for drug administration
d) Inborn, or born at site within the recruiting centre’s neonatal network where follow up will be possible

Are the trial subjects under 18? yes
Number of subjects for this age range: 810
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

a) In the opinion of the Principal Investigator, babies unlikely to survive until 48 hours after birth
b) Exposure to another macrolide antibiotic
c) Presence of major surgical or congenital abnormalities (not including patent ductus arteriosus or patent foramen ovale)
d) Infants born as part of a multiple pregnancy of three or more (i.e. triplets or more)
d) Participation in other clinical trials involving other investigational medicinal products