Evaluating RAM Cannula Use in Newborns on CPAP
Observational Study of Breathing and Flows in Bubble-CPAP Used With the RAM Cannula Interface in Newborn Infants
This study is testing if a special breathing device called the RAM Cannula helps newborns on CPAP breathe better and get the support they need for respiratory distress.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 0 Hours to 3 Months |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Hanoi) |
| Trial ID | NCT06697912 on ClinicalTrials.gov |
What this trial studies
This observational study examines the effectiveness of the RAM Cannula interface for newborn infants receiving bubble Continuous Positive Airway Pressure (bCPAP) treatment for respiratory distress. It aims to assess the impact of interface resistance on the quality of CPAP support, hypothesizing that exhalation through the device is uncommon and may restrict airflow. The study will involve clinically stable infants in the Phu San neonatal unit, collecting data on their respiratory support without any intervention. The findings could provide insights into optimizing respiratory therapy for newborns.
Who should consider this trial
Good fit: Ideal candidates include newborn infants admitted to the Phu San Hanoi Hospital Neonatology Unit who are stable and receiving bCPAP with the RAM interface.
Not a fit: Patients with major congenital malformations, severe respiratory needs, or those requiring immediate respiratory interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve respiratory support strategies for newborns with respiratory distress syndrome.
How similar studies have performed: While the RAM Cannula has not been extensively studied, similar approaches in optimizing CPAP delivery have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted to Phu San Hanoi Hospital Neonatology Unit * Support with bubble CPAP and RAM interface * Quiet and stable spontaneous breathing * Investigation team available Exclusion Criteria: * Problems with routine CPAP care * Major congenital malformation * Known syndrome or neuromuscular disease * Circulatory instability with inotropes * Oxygen need \>50% or CPAP \>10 cm H2O * Surfactant given the last 6 hours or expected to be needed the next 6 hours * Expected to need NIPPV or intubation within 6 hours * Recently extubated (\<24 h) * Recent large surgical procedure (\<5 days) * Nasal wound or irritation that hurts or is at risk of worsening during study
Where this trial is running
Hanoi
- Phu San Hanoi Hospital — Hanoi, Vietnam (Recruiting)
Study contacts
- Study coordinator: Hien Vu, MD
- Email: hien.vu@ki.se
- Phone: +84 904 999 455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.