Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants: the SToP-BPD study - SToP-BPD

Phase 1

• Conditions: bronchopulmonary dysplasia; MedDRA version: 12.1Level: LLTClassification code 10006475Term: Bronchopulmonary dysplasia

• Registration Number: EUCTR2010-023777-19-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-20
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Preterm infants with a gestational age < 30 wks and/or birth weight < 1250 g, ventilator dependent at 7-14 days PNA with a respiratory index (MAwP x FiO2) of = 3.5. This index should be present for more than 12 h/day for at least 48 hours and must ensure normal oxygen saturation (86-94%) and pCO2 values in premature infants (5.0-7.0 kPa).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Infants with chromosomal defects (e.g. trisomy 13, 18, 21) or major congenital malformations that are expected to compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia) or result in chronic ventilation (e.g. Pierre Robin sequence), or increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations) will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified