Respiratory Distress Syndrome (RDS)NCT06615427
FiO2 Delivered With Neonatal bCPAP
An observational study of Respiratory Distress Syndrome (RDS) and Infant, Premature, Diseases, run by Karolinska Institutet at 1 site in Vietnam.
Trial summary
Continuous positive airway pressure (CPAP) is the mainstay of treatment recommended for preterm infants with respiratory distress syndrome in all resource contexts. Many of the available bubble CPAP machines in low- and middle-income contexts mix flows of air and oxygen. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Respiratory Distress Syndrome (RDS), Infant, Premature, Diseases, Infant, Newborn, Diseases
- How many people
- 100 participants
- Where
- 1 siteVietnam
- Study dates
- 28 Sep 2024to 1 Feb 2025
- 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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: The study aims to include FiO2 measurements from bCPAP machines in use where the infants have stable spontaneous breathing and not expected to need urgent interventions.
Who may be able to join
- Admitted to Phu San Hanoi Hospital Neonatology Unit
- Bubble CPAP support with added O2
- ≥28 weeks GA
- Stable spontaneous breathing
- Investigation team available
Who cannot join
- Unstable infants in need of urgent intervention
- Major congenital malformation
- Known syndrome or neuromuscular disorder
- Circulatory instability with inotropes
- Recently extubated (\<24 h)
- Recent large surgical procedure (\<5 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delivered and Assessed FiO2 in Neonates With Respiratory Distress and Treated With Bubble-CPAP at a Neonatal Intensive Care Unit in Hanoi, Vietnam
Continuous positive airway pressure (CPAP) is the mainstay of treatment recommended for preterm infants with respiratory distress syndrome in all resource contexts. Many of the available bubble CPAP machines in low- and middle-income contexts mix flows of air and oxygen. These are adjusted by two separate rotameters (flowmeters) and estimate FiO2 delivery. Medical decisions regarding interventions to sick neonates such as need for intubation or surfactant administration are in large part dependant on a reliable estimation of FiO2-delivery. The aim of this study is to evaluate the accuracy of FiO2 delivered by bubble-CPAP machines with separate oxygen and air rotameters in patients at a neonatal intensive care unit (NICU) in Hanoi.
Read the detailed description
This is a cross-sectional observational study. The patient population will be a convenience sample with patients recruited when investigators are available, and the measurement is possible without interrupting planned care. There is no intervention apart from measurements of FiO2 in the breathing circuit and parents will be given the opportunity to decline participation. The study aims to include FiO2 measurements from bCPAP machines in use where the infants have stable spontaneous breathing and not expected to need urgent interventions. The main outcomes of the study are FiO2 displayed by the analyzer (chemical sensor), FiO2 recorded compared to FiO2 assessed from the rotameter flow using the conversion table. The clinicians estimating the rotameter flows are blinded to the delivered FiO2.
There are 22 bubble CPAP machines in the NICU. We aim to collect four or five measurements on each machine at a range of FiO2-levels generating a total of approximately 100 measurements. Differences in FiO2 of 0.04 would be considered clinically relevant, since it might have implication for decision of surfactant treatment or intubation. FiO2 accuracy will be investigated by comparing paired samples from visual assessed FiO2 and measured FiO2 (electrochemical sensor) by appropriate statistical tests. Variation between and within the two types of CPAP machines will be described. Analysis will also describe accuracy at different FiO2 levels and variance of accuracy between clinicians' bedside estimates.
The main application for ethical approval of the study will be to the Ethical Review Board at Phu San Hanoi Hospital. Analysis and data will be handled by researchers affiliated with Karolinska Institutet, and a second application will be filed at the Swedish Ethical Review Authority.
The risk for an infant participating in the study is minimal. Only infants with stable breathing will be included and measuring an infant is short with two brief interruptions in CPAP treatment. Pauses and interruptions of CPAP is common during normal care, for example when the nasal interfaces are repositioned, nares cleaned or tubes replaced. The infant is not moved and there is no handling of the infant or tests performed. Routine monitoring will be in place. The study takes place in the neonatal intensive care ward where there is immediate access to equipment and staff experienced with life support if an infant is sick. In that case the measurement can be immediately stopped without problems for the infant or the study.
For an infant there are no advantages or disadvantages with participating in the study. If the measured FiO2 deviates and this will affect management, the staff will be notified. This could for example be decisions regarding surfactant or mechanical ventilation. This is a potential advantage for the individual patients.
- Conditions
- Respiratory Distress Syndrome (RDS), Infant, Premature, Diseases, Infant, Newborn, Diseases
- Keywords
- Continuous Positive Airway Pressure, Respiratory Therapy
- Medical subject headings
- Respiratory Distress Syndrome, Infant, Premature, Diseases, Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infant treated with bubble CPAP and receiving blended air/oxygen | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
FiO2 delivered
FiO2 in breathing circuit using an oxygen sensor
Measured: 5 minutes
FiO2 estimated
FiO2 in breathing circuit estimated from flow meters by clinician
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start28 Sep 2024
- Primary completion14 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome (RDS)Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University, Hanoi Medical University, Hanoi Obstetrics and Gynecology Hospital
- Responsible party
- Principal investigator, Thomas Drevhammar, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615427
- Sponsor's protocol ID
- 2024-05506-01
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request after publication of results.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivered and Assessed FiO2 in Neonates With Respiratory Distress and Treated With Bubble-CPAP at a Neonatal Intensive Care Unit in Hanoi, Vietnam
- ClinicalTrials.gov ID
- NCT06615427
- Acronym / sponsor ID
- 2024-05506-01
- Conditions
- Respiratory Distress Syndrome (RDS), Infant, Premature, Diseases, Infant, Newborn, Diseases
- Keywords
- Continuous Positive Airway Pressure, Respiratory Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Göteborg University, Hanoi Medical University, Hanoi Obstetrics and Gynecology Hospital
- Study start
- 28 Sep 2024 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 26 Sep 2024 (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.
Continuous positive airway pressure (CPAP) is the mainstay of treatment recommended for preterm infants with respiratory distress syndrome in all resource contexts. Many of the available bubble CPAP machines in low- and middle-income contexts mix flows of air and oxygen. These are adjusted by two separate rotameters (flowmeters) and estimate FiO2 delivery. Medical decisions regarding interventions to sick neonates such as need for intubation or surfactant administration are in large part dependant on a reliable estimation of FiO2-delivery. The aim of this study is to evaluate the accuracy of FiO2 delivered by bubble-CPAP machines with separate oxygen and air rotameters in patients at a neonatal intensive care unit (NICU) in Hanoi.
Detailed description
This is a cross-sectional observational study. The patient population will be a convenience sample with patients recruited when investigators are available, and the measurement is possible without interrupting planned care. There is no intervention apart from measurements of FiO2 in the breathing circuit and parents will be given the opportunity to decline participation. The study aims to include FiO2 measurements from bCPAP machines in use where the infants have stable spontaneous breathing and not expected to need urgent interventions. The main outcomes of the study are FiO2 displayed by the analyzer (chemical sensor), FiO2 recorded compared to FiO2 assessed from the rotameter flow using the conversion table. The clinicians estimating the rotameter flows are blinded to the delivered FiO2.
There are 22 bubble CPAP machines in the NICU. We aim to collect four or five measurements on each machine at a range of FiO2-levels generating a total of approximately 100 measurements. Differences in FiO2 of 0.04 would be considered clinically relevant, since it might have implication for decision of surfactant treatment or intubation. FiO2 accuracy will be investigated by comparing paired samples from visual assessed FiO2 and measured FiO2 (electrochemical sensor) by appropriate statistical tests. Variation between and within the two types of CPAP machines will be described. Analysis will also describe accuracy at different FiO2 levels and variance of accuracy between clinicians' bedside estimates.
The main application for ethical approval of the study will be to the Ethical Review Board at Phu San Hanoi Hospital. Analysis and data will be handled by researchers affiliated with Karolinska Institutet, and a second application will be filed at the Swedish Ethical Review Authority.
The risk for an infant participating in the study is minimal. Only infants with stable breathing will be included and measuring an infant is short with two brief interruptions in CPAP treatment. Pauses and interruptions of CPAP is common during normal care, for example when the nasal interfaces are repositioned, nares cleaned or tubes replaced. The infant is not moved and there is no handling of the infant or tests performed. Routine monitoring will be in place. The study takes place in the neonatal intensive care ward where there is immediate access to equipment and staff experienced with life support if an infant is sick. In that case the measurement can be immediately stopped without problems for the infant or the study.
For an infant there are no advantages or disadvantages with participating in the study. If the measured FiO2 deviates and this will affect management, the staff will be notified. This could for example be decisions regarding surfactant or mechanical ventilation. This is a potential advantage for the individual patients.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant treated with bubble CPAP and receiving blended air/oxygen | – | – |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study aims to include FiO2 measurements from bCPAP machines in use where the infants have stable spontaneous breathing and not expected to need urgent interventions.
Key inclusion criteria (5 listed)
- Admitted to Phu San Hanoi Hospital Neonatology Unit
- Bubble CPAP support with added O2
- ≥28 weeks GA
- Stable spontaneous breathing
- Investigation team available
Key exclusion criteria (6 listed)
- Unstable infants in need of urgent intervention
- Major congenital malformation
- Known syndrome or neuromuscular disorder
- Circulatory instability with inotropes
- Recently extubated (\<24 h)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FiO2 delivered
Time frame: 5 minutes
FiO2 in breathing circuit using an oxygen sensor
FiO2 estimated
Time frame: 5 minutes
FiO2 in breathing circuit estimated from flow meters by clinician
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 20 May 2025.
- WHO guidelines including respiratory careLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request after publication of results.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (RDS) and Infant, Premature, Diseases, run by Karolinska Institutet at 1 site in Vietnam.
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 5 inclusion and 6 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 20 May 2025. 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 Vietnam. 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?
FiO2 delivered (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.