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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uninterrupted CPAP | Newborn infants in need of respiratory support directly after birth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uninterrupted CPAP for the first hours of life | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of interruptions in CPAP treatment | Number of CPAP-support interruptions (n) | 0-240 minutes |
| Duration of interruptions in CPAP treatment | Duration CPAP support interruptions (min) | 0-240 minutes |
| Cause of each interruption in CPAP treatment | Reported reason for interruptions in CPAP treatment (free text as reported by staff) | 0-240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of use: Respiratory support system set up | How easy was the system to set up? (Easy/Minor problems/Major difficulties) | 0-10 minutes |
| Ease of use: Airway and respiratory supportmanagement |
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Inclusion Criteria:
Exclusion Criteria:
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Newborn infants in need of respiratory support directly after birth. Consent will be obtained from parents before delivery. Infants will be enrolled when investigators are available (convenience sample).
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Drevhammar, PhD | meaning..... | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital, Neonatology department | Stockholm | 171 76 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38514168 | Derived | Baldursdottir S, Gunnarsdottir K, Donaldsson S, Jonsson B, Drevhammar T. Skin-to-skin stabilisation and uninterrupted respiratory support for preterm infants after birth: feasibility of a new and simplified rPAP system. Arch Dis Child Fetal Neonatal Ed. 2024 Oct 18;109(6):638-642. doi: 10.1136/archdischild-2023-326409. |
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| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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How easy was airway and respiratory support management with the new system? (Easy/Minor problems/Major difficulties)
| 0-60 minutes |
| Ease of use: Fixation and transport | How easy was fixation and transport from the delivery room? (Easy/Minor problems/Major difficulties) | 0-60 minutes |
| Level of respiratory support | What level of respiratory support was required? (Need for PPV, FiO2 and CPAP level) | 0-240 minutes |
| Response to respiratory support | How did the infant respond to the given respiratory support? (SpO2, PaCO2, Temperature) | 0-240 minutes |
| Respiratory support at 48 hours | What respiratory support did the infant receive at 48 hours of age | 0-240 minutes |
| Rare events in clinical management | Did any infant need chest compression, intubation or any other rare interventions? | 0-240 minutes |
| Adverse events and safety | Was there any suspected or confirmed adverse events related to equipment or the research protocol? | 0-240 minutes |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |