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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33377

Enrollment

Registered

2009-02-24

Start date

2009-04-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lung Disease (CLD) and Bronchopulmonary Dysplasia (BPD)

Interventions

One group receives on the first day salbutamol 0.1 mg/kg and 0.5 mg/kg on the second, given 4 times a day. The other group receives 0.5 mg/kg on day one and 0.1 mg/kg on day two.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Preterm infants suspect for developing BPD (> 35 wk PMA) who receive ventilatory support and/or oxygen therapy > 21% and clinically suspected of developing BPD.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main study endpoint is the fall in serum potassium.	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)