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Status:

WITHDRAWN

TINN2: Treat Infection in NeoNates 2

Lead Sponsor:

Institut National de la Santé Et de la Recherche Médicale, France

Collaborating Sponsors:

University of Liverpool

Cardiff University

Conditions:

Bronchopulmonary Dysplasia

Eligibility:

All Genders

23-28 years

Phase:

PHASE3

Brief Summary

The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates.

Detailed Description

In contrast to the situation in adults, most medicines used to treat the children of Europe have not been tested and are not authorised for use in children. In particular, 46% medicines prescribed to ...

Eligibility Criteria

Inclusion

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

Exclusion

  • In the opinion of the PI, babies unlikely to survive until 48 hours after birth
  • Exposure to another macrolide antibiotic
  • Presence of major surgical or congenital abnormalities (not including patent ductus arteriosus or patent foramen ovale)
  • Infants born as part of a multiple pregnancy of three or more (i.e. triplets or more)
  • Contraindication of azithromycin as specified in the summary of characteristics of the product.
  • Participation in other clinical trials involving Investigational Medicinal Products (IMPs)

Key Trial Info

Start Date :

January 1 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2018

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT02282176

Start Date

January 1 2015

End Date

January 1 2018

Last Update

February 25 2016

Active Locations (16)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (16 locations)

1

Centre Hospitalier Chrétien (CHC)

Liège, Belgium

2

Assistance Publique Hôpitaux de Paris (APHP)

Paris, France

3

Inserm-Transfert (IT)

Paris, France

4

Institut National de la Santé et de la Recherche Médicale (INSERM)

Paris, France