Feasibility study of a simplified respiratory support system for newborn infants
The study is a "proof-of-concept" feasibility trial that evaluates usage of a simplified respiratory support system for newborn infants. The study aims to evaluate both the feasibility of providing uninterrupted support for the first hours of life as well as a modified respiratory support system. The system is a modified version of the commercially available rPAP system. The revised design has a simplified gas supply and allows elimination of a complicated driver. The new system has low resistance to breathing equal to the rPAP system. The study will recruit 40-60 infants in a single centre without a comparison arm. The trial is conducted as a first step towards a large randomised trial.
Study Type
OBSERVATIONAL
Enrollment
32
Directly at birth the infant will be supported with PPV with PEEP as needed, followed by nasal CPAP. Support will be provided with a single device for up to four hours.
Karolinska University Hospital, Neonatology department
Stockholm, Sweden
Number of interruptions in CPAP treatment
Number of CPAP-support interruptions (n)
Time frame: 0-240 minutes
Duration of interruptions in CPAP treatment
Duration CPAP support interruptions (min)
Time frame: 0-240 minutes
Cause of each interruption in CPAP treatment
Reported reason for interruptions in CPAP treatment (free text as reported by staff)
Time frame: 0-240 minutes
Ease of use: Respiratory support system set up
How easy was the system to set up? (Easy/Minor problems/Major difficulties)
Time frame: 0-10 minutes
Ease of use: Airway and respiratory supportmanagement
How easy was airway and respiratory support management with the new system? (Easy/Minor problems/Major difficulties)
Time frame: 0-60 minutes
Ease of use: Fixation and transport
How easy was fixation and transport from the delivery room? (Easy/Minor problems/Major difficulties)
Time frame: 0-60 minutes
Level of respiratory support
What level of respiratory support was required? (Need for PPV, FiO2 and CPAP level)
Time frame: 0-240 minutes
Response to respiratory support
How did the infant respond to the given respiratory support? (SpO2, PaCO2, Temperature)
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Time frame: 0-240 minutes
Respiratory support at 48 hours
What respiratory support did the infant receive at 48 hours of age
Time frame: 0-240 minutes
Rare events in clinical management
Did any infant need chest compression, intubation or any other rare interventions?
Time frame: 0-240 minutes
Adverse events and safety
Was there any suspected or confirmed adverse events related to equipment or the research protocol?
Time frame: 0-240 minutes