Feasibility of Uninterrupted Infant Respiratory Support Treatment

Completed

• Conditions: Respiratory Insufficiency Syndrome of Newborn; Respiratory Distress Syndrome, Newborn; Infant, Newborn
• Interventions: Device: Uninterrupted CPAP for the first hours of life

• Registration Number: NCT04244890
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-28
• Study Start: 2020-02-21
• Status Verified: 2023-02
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Read More

Exclusion Criteria

• Carciac malformations
• Airway malformations
• Known syndromes or neuromuscular disorders
• Transfer to other hospital within 4 hours likely

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uninterrupted CPAP	Uninterrupted CPAP for the first hours of life	Newborn infants in need of respiratory support directly after birth

Primary Outcome Measures

Name	Time	Method
Cause of each interruption in CPAP treatment	0-240 minutes	Reported reason for interruptions in CPAP treatment (free text as reported by staff)
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)

Secondary Outcome Measures

Name	Time	Method
Respiratory support at 48 hours	0-240 minutes	What respiratory support did the infant receive at 48 hours of age
Ease of use: Fixation and transport	0-60 minutes	How easy was fixation and transport from the delivery room? (Easy/Minor problems/Major difficulties)
Level of respiratory support	0-240 minutes	What level of respiratory support was required? (Need for PPV, FiO2 and CPAP level)
Ease of use: Respiratory support system set up	0-10 minutes	How easy was the system to set up? (Easy/Minor problems/Major difficulties)
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)
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?
Response to respiratory support	0-240 minutes	How did the infant respond to the given respiratory support? (SpO2, PaCO2, Temperature)

Trial Locations

Locations (1)

Karolinska University Hospital, Neonatology department; 🇸🇪 Stockholm, Sweden