Infant, Newborn, Respiratory Distress Syndrome, Newborn, Respiratory Insufficiency Syndrome of Newborn
Conditions
Keywords
Continuous Positive Airway Pressure, Resuscitation
Brief summary
Feasibility study of a simplified respiratory support system for newborn infants
Detailed description
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.
Interventions
DEVICEUninterrupted CPAP for the first hours of life
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.
Sponsors
Karolinska Institutet
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Vaginal delivery at gestational age between 28+0 and 34+6 * Caesarean section at gestational age between 28+0 and 37+6 * Infants in need of respiratory support in delivery-room
Exclusion criteria
* Carciac malformations * Airway malformations * Known syndromes or neuromuscular disorders * Transfer to other hospital within 4 hours likely
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of interruptions in CPAP treatment | 0-240 minutes | Number of CPAP-support interruptions (n) |
| Duration of interruptions in CPAP treatment | 0-240 minutes | Duration CPAP support interruptions (min) |
| Cause of each interruption in CPAP treatment | 0-240 minutes | Reported reason for interruptions in CPAP treatment (free text as reported by staff) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of respiratory support | 0-240 minutes | What level of respiratory support was required? (Need for PPV, FiO2 and CPAP level) |
| Response to respiratory support | 0-240 minutes | How did the infant respond to the given respiratory support? (SpO2, PaCO2, Temperature) |
| Ease of use: Respiratory support system set up | 0-10 minutes | How easy was the system to set up? (Easy/Minor problems/Major difficulties) |
| Rare events in clinical management | 0-240 minutes | Did any infant need chest compression, intubation or any other rare interventions? |
| Adverse events and safety | 0-240 minutes | Was there any suspected or confirmed adverse events related to equipment or the research protocol? |
| Respiratory support at 48 hours | 0-240 minutes | What respiratory support did the infant receive at 48 hours of age |
| Ease of use: Airway and respiratory supportmanagement | 0-60 minutes | How easy was airway and respiratory support management with the new system? (Easy/Minor problems/Major difficulties) |
| Ease of use: Fixation and transport | 0-60 minutes | How easy was fixation and transport from the delivery room? (Easy/Minor problems/Major difficulties) |
Countries
Sweden
Outcome results
None listed