Using a new laryngeal mask to give surfactant to premature babies with breathing problems
A Single-arm, Prospective Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates, with Respiratory Distress Syndrome, At a Level III Neonatal Intensive Care Unit in Hanoi, Vietnam
This study is testing a new smaller breathing mask to see if it can safely deliver a medicine to help premature babies with breathing problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | N/A to 48 Hours |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Hanoi) |
| Trial ID | NCT06606444 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of administering surfactant through a newly designed, smaller laryngeal mask airway (LMA) in very low birth weight neonates suffering from respiratory distress syndrome (RDS). The approach involves placing the LMA while the infant is spontaneously breathing and receiving non-invasive respiratory support. Investigators will assess the success of LMA placement, the time taken, the number of attempts required, and the stability of the neonate during the procedure. The study will be conducted at Phu San Hanoi Hospital, which has a specialized neonatal intensive care unit.
Who should consider this trial
Good fit: Ideal candidates for this study are inborn neonates weighing between 750g and 1500g, born before 34 weeks of gestation, and diagnosed with RDS requiring non-invasive respiratory support.
Not a fit: Patients who may not benefit include those with severe respiratory insufficiency requiring emergency intubation or those who have previously received surfactant treatment.
Why it matters
Potential benefit: If successful, this method could provide a less invasive and more effective way to deliver surfactant to premature infants, potentially improving their respiratory outcomes.
How similar studies have performed: While the use of laryngeal mask airways for surfactant administration is a novel approach, similar studies have shown promise in other populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parental informed consent, AND * Inborn neonate (=born in the hospital), AND * Gestational age less than 34 + 0 weeks, AND * Age less than 48 hours, AND * Birth weight from 750g to 1500g, AND * Clinical diagnosis of RDS requiring non-invasive respiratory support (CPAP/NIPPV) and fraction of inspired oxygen (FiO2) 0.30-0.60 to maintain oxygen saturation (SpO2) between 90% and 95%. Exclusion Criteria: * Severe respiratory insufficiency in need of emergency intubation * Previous surfactant administration * Previous mechanical ventilation * Known pneumothorax * Major malformations * Investigators not available
Where this trial is running
Hanoi
- Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital — Hanoi, Vietnam (Recruiting)
Study contacts
- Principal investigator: Tobias Alfvén, Professor, M.D, Ph.D — Karolinska Institutet
- Study coordinator: Tobias Alfvén, Professor, M.D, Ph.D
- Email: tobias.alfven@ki.se
- Phone: +46 70 757 80 93
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.