FUIRST: Feasibility of Uninterrupted Infant Respiratory Support Treatment

Sponsor
Karolinska Institutet (Other)
Overall Status
Recruiting
CT.gov ID
NCT04244890
Collaborator
(none)
50
1
35.4
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Study Details

Study Description

Brief Summary

Feasibility study of a simplified respiratory support system for newborn infants

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
Feb 21, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Number of interruptions in CPAP treatment [0-240 minutes]

    Number of CPAP-support interruptions (n)

  2. Duration of interruptions in CPAP treatment [0-240 minutes]

    Duration CPAP support interruptions (min)

  3. Cause of each interruption in CPAP treatment [0-240 minutes]

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

Secondary Outcome Measures

  1. Ease of use: Respiratory support system set up [0-10 minutes]

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

  2. 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)

  3. Ease of use: Fixation and transport [0-60 minutes]

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

  4. Level of respiratory support [0-240 minutes]

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

  5. Response to respiratory support [0-240 minutes]

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

  6. Respiratory support at 48 hours [0-240 minutes]

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

  7. Rare events in clinical management [0-240 minutes]

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

  8. Adverse events and safety [0-240 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska University Hospital, Neonatology department Stockholm Sweden 171 76

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

  • Study Director: Thomas Drevhammar, PhD, meaning.....

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Drevhammar, Senior Consultant, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04244890
Other Study ID Numbers:
  • 2019-05581
First Posted:
Jan 28, 2020
Last Update Posted:
Jul 6, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Thomas Drevhammar, Senior Consultant, PhD, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022