Aerosolised salbutamol in two doses as a treatment for preterm infants with developing bronchopulmonary dysplasia. - Salbutamol for developing BPD

• Conditions: Preterm infants developing bronchopulmonary dysplasia; MedDRA version: 9.1Level: LLTClassification code 10006475Term: Bronchopulmonary dysplasia

• Registration Number: EUCTR2009-010381-30-NL
• Lead Sponsor: Isala klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Preterm infants (< 35 wk PMA) who receive ventilatory support and oxygen therapy > 21% and clinically suspected of developing BPD.
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

Neonates with ‘major’ congenital malformations, neonates with a life expectancy of less than 72 hours, neonates who receive potassium supplementation.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Is a higher dose of aerosolised salbutamol as a treatment for preterm infants suspected for developing BPD more effective than a lower dose on short-term clinical effects?;Secondary Objective: ;Primary end point(s): Main study endpoint is the fall in plasma potassium. Secondary parameters are heart rate, level of oxygen supplementation, respirator settings/height of the CPAP-flow, behaviour and dyspnea of the child during inhalation, saturation and events of apnea.