Feasibility of Uninterrupted Infant Respiratory Support Treatment

Study Overview
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Brief Summary
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Feasibility study of a simplified respiratory support system for newborn infants

Detailed Description
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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.

Official Title
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Feasibility of Respiratory Management of Infants Needing Positive Pressure Ventilation or CPAP, Using a Single System to Deliver Uninterrupted Support Directly at Birth and the First Hours of Life

Conditions
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Respiratory Distress Syndrome, Newborn, Infant, Newborn, Respiratory Insufficiency Syndrome of Newborn

Intervention / Treatment
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* Device: Uninterrupted CPAP for the first hours of life


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Uninterrupted CPAP<br>Newborn infants in need of respiratory support directly after birth | Device: Uninterrupted CPAP for the first hours of life<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Positive Airway Pressure, Resuscitation