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Immediate Stimulation to Prevent and Inhibit cardiorespiratory Events in preterm infants

Immediate Stimulation to Prevent and Inhibit cardiorespiratory Events in preterm infants - InSPIRE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50955
Enrollment
16
Registered
2021-06-11
Start date
2021-07-16
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

apnea respiratory pause

Interventions

Preterm infants will receive automated mechanical tactile stimulation from the BreatheBuddy in response to cardiorespiratory events.

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Safety and feasibility measures. Primary outcome will be the success in providing automated tactile stimulation using the BreatheBuddy.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)