Evaluate the safety and feasibility of providing automated tactile stimulation in response to apnea, bradycardia and/or desaturation using the BreatheBuddy.
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and feasibility measures. Primary outcome will be the success in
providing automated tactile stimulation using the BreatheBuddy.
Secondary outcome
N/A
Background summary
Most preterm infants have difficulties breathing on their own, resulting in
apnea, bradycardia and/or hypoxia. Despite preventive therapies, some infant
often require adequate reactive intervention of the nurse in the form of
tactile stimulation. In the current situation, the duration of apnea,
bradycardia and hypoxia fully relies on the response time of the nurse. Our
general hypothesis is that automated mechanical stimulation will shorten apnea,
hypoxia and bradycardia by enabling a direct response. To test this hypothesis
we designed the BreatheBuddy, a mechanical stimulation system for preterm
infant that automatically responds to cardiorespiratory alarms of the patient
monitor.
Study objective
Evaluate the safety and feasibility of providing automated tactile stimulation
in response to apnea, bradycardia and/or desaturation using the BreatheBuddy.
Study design
a prospective randomized cross-over pilot study at the Neonatal Intensive Care
Unit of the Leiden University Medical Center.
Intervention
Preterm infants will receive automated mechanical tactile stimulation from the
BreatheBuddy in response to cardiorespiratory events.
Study burden and risks
The infant participating in this study will be exposed to minimal risk.
However, because of their vulnerable stat we will closely monitor the effects
and (unforeseen) side effects of the BreatheBuddy. There are potential
benefits, but a larger RCT is needed to confirm this.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Born between 24 weeks 0 days and 29 weeks and 6 days gestation.
Receiving non-invasive respiratory support (NCPAP or NIPPV).
Occurrence of apnea, bradycardia or desaturation of >10 seconds > 1 per hour,
but otherwise clinically stable.
Expected to complete the 48-hour period with non-invasive respiratory support.
Written informed parental consent.
Exclusion criteria
Major congenital anomalies that have an adverse effect on breathing or
ventilation.
Suspected or proven sepsis
Comfort score >14; comfort is scored by a nurse on 6 items with a 5-point
Likert scale. When the sum of these scores is >14 the patient is experiencing
discomfort which requires the nurse to look for the cause and, in case it does
not improve, provide pain medication.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77214.058.21 |
| OMON | NL-OMON29343 |