eonatal European Study of Inhaled Steroids

Phase 3

Completed

• Conditions: Bronchopulmonary dysplasia; Neonatal Diseases; Chronic respiratory disease originating in the perinatal period

• Registration Number: ISRCTN80181452
• Lead Sponsor: niversity Children`s Hospital of Tuebingen (Germany)

Brief Summary

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19590247 2. 2015 results in https://www.nejm.org/doi/full/10.1056/NEJMoa1501917 3. 2018 results in https://www.nejm.org/doi/full/10.1056/NEJMoa1708831

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-26
• Study Completion: 2012-03-31
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

1. Gestational age of 23 0/7 - 27 6/7 weeks
2. Postnatal age less than 12 hours
3. Necessity for any form of positive pressure support (mechanical or nasal ventilation or continuous positive airway pressure [CPAP])
4. Singleton or second born in case of multiple pregnancy
5. Parental consent for participation

Exclusion Criteria

1. Clinical decision not to administer therapies (infant not considered viable)
2. Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
3. Known or suspected congenital heart disease (not including a persistent ductus arteriosus and/or an atrial septum defect)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combination of BPD or death at 36 weeks gestational age

Secondary Outcome Measures

Name	Time	Method
1. All cause mortality at 36 weeks gestational age<br>2. BPD at 36 weeks gestational age<br>3. Duration of positive pressure respiratory support and supplemental oxygen<br>4. Neurodevelopmental disability at 18 - 22 months corrected age<br>5. Adverse treatment effects<br>6. All grades of intraventricular haemorrhage (IVH) and/or peri-ventricular leukomalacia (PVL)<br>7. Patent ductus arteriosus (PDA)<br>8. Intestinal perforations and/or necrotising enterocolitis (NEC) (Bell stage 2 - 3)<br>9. Retinopathy of prematurity (ROP)<br>10. Culture proven infections<br>11. Growth<br>12. Length of hospitalisation<br>13. Infants requiring re-intubation