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?
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoint is the fall in serum potassium.
Secondary outcome
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.
Background summary
BPD remains a major cause of morbidity and mortality among premature infants (<
37 weeks PMA). The incidence increases as birth weight decreases. Clinical
features of BPD are hypoxemia, need for oxygen therapy and need for
ventilatory support. The pathophysiology is characterised by decreased lung
compliance, increased airway resistance and bronchospasms. Bronchodilators as
salbutamol show improvements in saturation, tidal volume, compliance and
resistance. It remains unclear in which dosage salbutamol should be prescribed.
Presumably the dose-related effect is responsible for the differences in (the
satisfaction about) the use of aerosolised salbutamol, however, among NICUs in
the Netherlands there is no consensus regarding the dosage. Therefore we would
like to start a pilotstudy to compare dose-related effect.
Study 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?
Study design
Double-blind randomised cross-over trial, a pilot study.
Intervention
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.
Study burden and risks
A benefit for infants is the possible association of a better clinical
condition using a higher dose of salbutamol. Health risks or any other burden
associated with participation are not expected.
Dokter van Heesweg 2
8025 AB Zwolle
NL
Dokter van Heesweg 2
8025 AB Zwolle
NL
Listed location countries
Age
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
Neonates with major congenital malformations, neonates with a life expectancy of less than 72 hours, neonates who receive potassium supplementation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-010381-30-NL |
| CCMO | NL27073.075.09 |