Immediate Stimulation to Prevent and Inhibit cardioRespiratory Events In preterm infants

Rationale: 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.
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.
Study population: Preterm infants that are admitted to the NICU in Leiden. We will include 2 groups of infants with a different gestational age range, starting with 8 infants of 27-30 weeks gestation, followed by 8 infants of 24-27 weeks gestation.
Intervention: Preterm infants will receive automated mechanical tactile stimulation from the BreatheBuddy in response to cardiorespiratory events.
Main study parameters/endpoints: Safety and feasibility measures. Primary outcome will be the success in providing automated tactile stimulation using the BreatheBuddy.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The infant participating in this study will be exposed to minimal risk. However, because of their vulnerable state 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.

It is safe and feasible to provide direct automatic mechanical tactile stimulation with the BreatheBuddy in preterm infants with frequent cardiorespiratory events

2x 24 hours

Providing direct automatic mechanical tactile stimulation with the BreatheBuddy in response to cardiorespiratory events indicated by the alarm lights.