Comparing synchronized and non-synchronized ventilation in preterm infants
Short Term Effects of Synchronized vs. Non-synchronized NIPPV in Preterm Infants: Study Protocol for an Unmasked Randomized Crossover Trial.
NA · University of Turin, Italy · NCT03289936
This study is testing whether synchronized or non-synchronized breathing support helps preterm infants born before 32 weeks breathe better and have fewer complications after birth.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 32 Weeks |
| Sex | All |
| Sponsor | University of Turin, Italy (other) |
| Locations | 1 site (Torino, (to)) |
| Trial ID | NCT03289936 on ClinicalTrials.gov |
What this trial studies
This study compares the effects of synchronized nasal intermittent positive pressure ventilation (SNIPPV) versus non-synchronized nasal intermittent positive pressure ventilation (NIPPV) on cardio-respiratory adaptation in preterm infants born before 32 weeks of gestation. The research focuses on infants' first experience with non-invasive ventilation, either immediately after birth or following extubation. By evaluating the differences in respiratory support techniques, the study aims to determine which method leads to better outcomes in terms of respiratory distress and complications like bronchopulmonary dysplasia.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants with a gestational age at birth of less than 32 weeks who are undergoing their first approach to non-invasive ventilation.
Not a fit: Patients with significant neurological issues, congenital anomalies, or contraindications to non-invasive ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve respiratory support strategies for preterm infants, potentially reducing complications and improving survival rates.
How similar studies have performed: Previous studies have shown that NIPPV can be superior to other non-invasive techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age at birth \<32 weeks * First approach to NIV ventilation (primary or after extubation) * Parent's informed consent Exclusion Criteria: * Neurological (including IVH \> 2° grade) or surgical diseases * Sepsis (clinical or laboratory confirmed) * Chromosomal or genetic abnormalities * Major malformations and congenital anomalies * Cardiac problems (including hemodynamically significant PDA) * Contraindication to NIV (i.e. nasal trauma and gastrointestinal surgery within the previous 7 days).
Where this trial is running
Torino, (to)
- Ospedale S.Anna di Torino — Torino, (to), Italy (RECRUITING)
Study contacts
- Principal investigator: Elena Maggiora, MD — Città della Salute e della Scienza - Ospedale S.Anna - University of Turin
- Study coordinator: Francesco Cresi, PhD, MD
- Email: francesco.cresi@unito.it
- Phone: +39 11 3135781
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.
Conditions: Newborn Respiratory Distress, Preterm Infant, preterm, ventilation, nasal intermittent positive pressure ventilation, synchronization, cardio-respiratory events, newborn