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Completed

NCT Number: NCT04244890

Feasibility of Uninterrupted Infant Respiratory Support Treatment

Feasibility study of a simplified respiratory support system for newborn infants

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Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Insufficiency Syndrome of Newborn Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital, Neonatology department

Stockholm, 171 76, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of interruptions in CPAP treatment

    Time frame: 0-240 minutes

    Number of CPAP-support interruptions (n)

  2. Duration of interruptions in CPAP treatment

    Time frame: 0-240 minutes

    Duration CPAP support interruptions (min)

  3. Cause of each interruption in CPAP treatment

    Time frame: 0-240 minutes

    Reported reason for interruptions in CPAP treatment (free text as reported by staff)

Secondary outcomes

  1. Ease of use: Respiratory support system set up

    Time frame: 0-10 minutes

    How easy was the system to set up? (Easy/Minor problems/Major difficulties)

  2. Ease of use: Airway and respiratory supportmanagement

    Time frame: 0-60 minutes

    How easy was airway and respiratory support management with the new system? (Easy/Minor problems/Major difficulties)

  3. Ease of use: Fixation and transport

    Time frame: 0-60 minutes

    How easy was fixation and transport from the delivery room? (Easy/Minor problems/Major difficulties)

  4. Level of respiratory support

    Time frame: 0-240 minutes

    What level of respiratory support was required? (Need for PPV, FiO2 and CPAP level)

  5. Response to respiratory support

    Time frame: 0-240 minutes

    How did the infant respond to the given respiratory support? (SpO2, PaCO2, Temperature)

  6. Respiratory support at 48 hours

    Time frame: 0-240 minutes

    What respiratory support did the infant receive at 48 hours of age

  7. Rare events in clinical management

    Time frame: 0-240 minutes

    Did any infant need chest compression, intubation or any other rare interventions?

  8. Adverse events and safety

    Time frame: 0-240 minutes

    Was there any suspected or confirmed adverse events related to equipment or the research protocol?

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study 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

Acronym: FUIRST

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2020
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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