Optimizing BiPAP Levels for Premature Infants
Crossover Study of the Work of Breathing at Different Levels of BiPAP Settings in Neonates
This study tests different pressure settings on a breathing machine to see which one helps premature babies breathe easier.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 2 Days to 2 Months |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06421519 on ClinicalTrials.gov |
What this trial studies
This study investigates the optimal upper pressure settings of BiPAP, a non-invasive respiratory support system, for premature infants with breathing difficulties. Researchers will assess the work of breathing in infants by applying three different upper pressure levels for 20 minutes each while maintaining a constant baseline pressure. The goal is to determine which pressure setting provides the least work of breathing, thereby improving respiratory support for infants with bronchopulmonary dysplasia. The study aims to recruit 21 preterm infants who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born before 34 weeks of gestation who require respiratory support.
Not a fit: Infants with congenital respiratory abnormalities or confirmed sepsis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory support for premature infants, potentially reducing the severity of bronchopulmonary dysplasia.
How similar studies have performed: While other forms of non-invasive ventilation have shown success, this specific approach using BiPAP settings is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm infants born \<34 weeks of gestation at KCH requiring primary respiratory support before intubation, after extubation or requiring respiratory support after seven days * Infants aged between 2 days and 2 months at time of study Exclusion Criteria: * Infants with congenital abnormalities of the respiratory system. * Infants with blood-culture confirmed sepsis. * Recent gastrointestinal surgery (within 7 days) * Non-English speakers
Where this trial is running
London
- King's College Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Theodore Dassios — King's College Hospital NHS Trust
- Study coordinator: Oishi Sikdar
- Email: oishi.sikdar2@nhs.net
- Phone: 07901931550
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.