Nasal MaskNCT06310408
Comparison Between Nasal Mask vs Nasal Prong on Pain Response in Neonate
A study testing nasal mask and nasal prong in people with Nasal Mask and Nasal Prong, run by Universitas Indonesia.
Trial summary
to determine the comparison of nasal masks and nasal prongs on the pain response of neonate Read more about this study
- Who is it for?
- Ages 26 to 44 weeks
- Conditions the study is for
- Nasal Mask, Nasal Prong
- What is being tested?
- nasal mask and nasal prong
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 1 Jun 2024
- Phase
- Interventional
- 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 26 to 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn with espiratory distress and need noninvasive respiratory support
Who cannot join
- Syok, multiple congenital anomaly
Trial locations and contacts
No sites are listed yet.
About this study
to determine the comparison of nasal masks and nasal prongs on the pain response of neonate
Read the detailed description
To see the comparison of nasal masks and nasal prongs on the pain response of neonates, by measuring salivary cortisol levels before and after the intervention
- Conditions
- Nasal Mask, Nasal Prong
- Being tested
- nasal mask, nasal prong
- Keywords
- nasal mask, nasal prong, pain response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal maskDevice
Give interface nasal mask
nasal prongDevice
give interface nasal prong
| Study group | Role | What they receive |
|---|---|---|
| nasal mask | Experimental | Give noninvasif respiratory support with interface nasal mask Receives: Device: nasal mask |
| nasal prong | Active comparator | Give noninvasif respiratory support with interface nasal prong Receives: Device: nasal prong |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain response
kortisol saliva level
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal MaskStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 group give nasal mask 1 group give nasal prong
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Besse Sarmila, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310408
- Sponsor's protocol ID
- 0214022024
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Nasal Mask vs Nasal Prong on Pain Response in Neonate
- ClinicalTrials.gov ID
- NCT06310408
- Acronym / sponsor ID
- 0214022024
- Conditions
- Nasal Mask, Nasal Prong
- Keywords
- nasal mask, nasal prong, pain response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 15 Mar 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.
to determine the comparison of nasal masks and nasal prongs on the pain response of neonate
Detailed description
To see the comparison of nasal masks and nasal prongs on the pain response of neonates, by measuring salivary cortisol levels before and after the intervention
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 group give nasal mask 1 group give nasal prong
| Arm | Type | Receives |
|---|---|---|
| nasal mask | Experimental | Device: nasal maskGive noninvasif respiratory support with interface nasal mask |
| nasal prong | Active comparator | Device: nasal prongGive noninvasif respiratory support with interface nasal prong |
Who may qualify
- Ages
- 26 to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborn with espiratory distress and need noninvasive respiratory support
Key exclusion criteria (1 listed)
- Syok, multiple congenital anomaly
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 |
|---|---|---|
| nasal maskGive interface nasal mask | Device | nasal mask |
| nasal pronggive interface nasal prong | Device | nasal prong |
Primary outcome
pain response
Time frame: 20 weeks
kortisol saliva level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Yes
Related trials for Nasal Mask
Not yet recruiting
Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese Patients
Obesity
Not yet recruiting
Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence Induction
Hypoxemia, Airway Management
Recruiting
HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation
Procedural Sedation, Hypoxemia
Recruiting
High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery
Hypoxemia During Surgery
Active, not recruitingObservational study
Comparison of Laryngeal Mask and Tracheal Intubation With and Without Topical Lidocaine Application
Comparison of Airway Management Techniques in Functional Endoscopic Sinus Surgery, Rhinosinusitis With Polyps
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.
Questions about this trial
What is this clinical trial studying?
A study testing nasal mask and nasal prong in people with Nasal Mask and Nasal Prong, run by Universitas Indonesia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Besse Sarmila (081342540966, bessesarmila96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain response (time frame: 20 weeks). 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 15 Mar 2024.