Feasibility of Uninterrupted Infant Respiratory Support Treatment (FUIRST)

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

Feasibility study of a simplified respiratory support system for newborn infants

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Newborn; Infant, Newborn; Respiratory Insufficiency Syndrome of Newborn
• Intervention / Treatment: Device: Uninterrupted CPAP for the first hours of life

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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska University Hospital, Neonatology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Uninterrupted CPAP; Newborn infants in need of respiratory support directly after birth	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Study Director: Thomas Drevhammar, PhD, meaning.....

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 21, 2020
• Primary Completion (ACTUAL): February 1, 2023
• Study Completion (ACTUAL): February 1, 2023

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (ACTUAL): January 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Resuscitation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 2019-05581

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No