Feasibility of Uninterrupted Infant Respiratory Support Treatment

Infant, Newborn Clinical Trial

— FUIRST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244890
• Other study ID #: 2019-05581
• Status: Completed
• Start date: February 21, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Feasibility study of a simplified respiratory support system for newborn infants

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Uninterrupted 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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital, Neonatology department	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of interruptions in CPAP treatment	Number of CPAP-support interruptions (n)	0-240 minutes
Primary	Duration of interruptions in CPAP treatment	Duration CPAP support interruptions (min)	0-240 minutes
Primary	Cause of each interruption in CPAP treatment	Reported reason for interruptions in CPAP treatment (free text as reported by staff)	0-240 minutes
Secondary	Ease of use: Respiratory support system set up	How easy was the system to set up? (Easy/Minor problems/Major difficulties)	0-10 minutes
Secondary	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
Secondary	Ease of use: Fixation and transport	How easy was fixation and transport from the delivery room? (Easy/Minor problems/Major difficulties)	0-60 minutes
Secondary	Level of respiratory support	What level of respiratory support was required? (Need for PPV, FiO2 and CPAP level)	0-240 minutes
Secondary	Response to respiratory support	How did the infant respond to the given respiratory support? (SpO2, PaCO2, Temperature)	0-240 minutes
Secondary	Respiratory support at 48 hours	What respiratory support did the infant receive at 48 hours of age	0-240 minutes
Secondary	Rare events in clinical management	Did any infant need chest compression, intubation or any other rare interventions?	0-240 minutes
Secondary	Adverse events and safety	Was there any suspected or confirmed adverse events related to equipment or the research protocol?	0-240 minutes