Respiratory Distress Syndrome, NewbornFUIRSTNCT04244890
Feasibility of Uninterrupted Infant Respiratory Support Treatment
An observational study of Respiratory Distress Syndrome, Newborn and Infant, Newborn, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Feasibility study of a simplified respiratory support system for newborn infants Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Infant, Newborn, Respiratory Insufficiency Syndrome of Newborn
- What is being tested?
- Uninterrupted CPAP for the first hours of life
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- 21 Feb 2020to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Carciac malformations
- Airway malformations
- Known syndromes or neuromuscular disorders
- Transfer to other hospital within 4 hours likely
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska University Hospital, Neonatology department
Stockholm, 171 76
About this study
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
Feasibility study of a simplified respiratory support system for newborn infants
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Newborn, Infant, Newborn, Respiratory Insufficiency Syndrome of Newborn
- Being tested
- Uninterrupted CPAP for the first hours of life
- Keywords
- Continuous Positive Airway Pressure, Resuscitation
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uninterrupted CPAP for the first hours of lifeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Uninterrupted CPAP | Newborn infants in need of respiratory support directly after birth Receives: Device: Uninterrupted CPAP for the first hours of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of interruptions in CPAP treatment
Number of CPAP-support interruptions (n)
Measured: 0-240 minutes
Duration of interruptions in CPAP treatment
Duration CPAP support interruptions (min)
Measured: 0-240 minutes
Cause of each interruption in CPAP treatment
Reported reason for interruptions in CPAP treatment (free text as reported by staff)
Measured: 0-240 minutes
Secondary outcomes (8)
Ease of use: Respiratory support system set up
How easy was the system to set up? (Easy/Minor problems/Major difficulties)
Measured: 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)
Measured: 0-60 minutes
Ease of use: Fixation and transport
How easy was fixation and transport from the delivery room? (Easy/Minor problems/Major difficulties)
Measured: 0-60 minutes
Level of respiratory support
What level of respiratory support was required? (Need for PPV, FiO2 and CPAP level)
Measured: 0-240 minutes
Response to respiratory support
How did the infant respond to the given respiratory support? (SpO2, PaCO2, Temperature)
Measured: 0-240 minutes
Respiratory support at 48 hours
What respiratory support did the infant receive at 48 hours of age
Measured: 0-240 minutes
Rare events in clinical management
Did any infant need chest compression, intubation or any other rare interventions?
Measured: 0-240 minutes
Adverse events and safety
Was there any suspected or confirmed adverse events related to equipment or the research protocol?
Measured: 0-240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start21 Feb 2020
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Drevhammar, Karolinska Institutet
- Investigators
- Thomas Drevhammar, PhD, Study director, meaning.....
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244890
- Sponsor's protocol ID
- 2019-05581
- Other IDs
- 2019
- Acronym
- FUIRST
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2020
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baldursdottir S, Gunnarsdottir K, Donaldsson S, Jonsson B, Drevhammar T. Skin-to-skin stabilisation and uninterrupted respiratory support for preterm infants after birth: feasibility of a new and simplified rPAP system. Arch Dis Child Fetal Neonatal Ed. 2024 Oct 18;109(6):638-642. doi: 10.1136/archdischild-2023-326409.
PubMed 38514168
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04244890
- Acronym / sponsor ID
- FUIRST / 2019-05581
- Conditions
- Respiratory Distress Syndrome, Newborn, Infant, Newborn, Respiratory Insufficiency Syndrome of Newborn
- Keywords
- Continuous Positive Airway Pressure, Resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uninterrupted CPAP | – | Device: Uninterrupted CPAP for the first hours of lifeNewborn infants in need of respiratory support directly after birth |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Carciac malformations
- Airway malformations
- Known syndromes or neuromuscular disorders
- Transfer to other hospital within 4 hours likely
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uninterrupted CPAP for the first hours of lifeDirectly 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. | Device | Uninterrupted CPAP |
Primary outcome
Number of interruptions in CPAP treatment
Time frame: 0-240 minutes
Number of CPAP-support interruptions (n)
Duration of interruptions in CPAP treatment
Time frame: 0-240 minutes
Duration CPAP support interruptions (min)
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)
8 secondary outcomes
Ease of use: Respiratory support system set up
Time frame: 0-10 minutes
Ease of use: Airway and respiratory supportmanagement
Time frame: 0-60 minutes
Ease of use: Fixation and transport
Time frame: 0-60 minutes
Level of respiratory support
Time frame: 0-240 minutes
Response to respiratory support
Time frame: 0-240 minutes
Respiratory support at 48 hours
Time frame: 0-240 minutes
Rare events in clinical management
Time frame: 0-240 minutes
Adverse events and safety
Time frame: 0-240 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Derived from this study: PubMed 38514168Baldursdottir S, Gunnarsdottir K, Donaldsson S, Jonsson B, Drevhammar T. Skin-to-skin stabilisation and uninterrupted respiratory support for preterm infants after birth: feasibility of a new and simplified rPAP system. Arch Dis Child Fetal Neonatal Ed. 2024 Oct 18;109(6):638-642. doi: 10.1136/archdischild-2023-326409.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Drevhammar, PhD study director
meaning.....
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Newborn and Infant, Newborn, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of interruptions in CPAP treatment (time frame: 0-240 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04244890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.