Breathing support methods for preterm infants
Respiratory Support and Brain Health in Preterm Infants: a Prospective Crossover Study
Mount Sinai Hospital, Canada · NCT05589831
This study is testing whether a new breathing support method for preterm infants can help them sleep better and stay healthier compared to the standard method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 3 Days and up |
| Sex | All |
| Sponsor | Mount Sinai Hospital, Canada (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05589831 on ClinicalTrials.gov |
What this trial studies
This observational study compares two methods of non-invasive breathing support in preterm infants born under 32 weeks gestation. The focus is on Neurally Adjusted Ventilatory Assist (NIV-NAVA) versus standard Non-Invasive Positive Pressure Ventilation (NIPPV) to assess their effects on sleep-wake cycling, cerebral oxygenation, heart rate variability, and diaphragm function. The study aims to determine if NIV-NAVA provides better neuroprotection and comfort for these vulnerable infants during their critical period of development.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born between 22 and 31 weeks gestation who are clinically stable and receiving non-invasive breathing support.
Not a fit: Patients with severe brain injuries, congenital abnormalities, or those who do not meet the stability criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory support techniques that enhance brain development in preterm infants.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for preterm infants with non-invasive ventilation techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm infants born between 22+0 and 31+6 weeks' GA * Weight \> 500 g at the time of approach for consent * A minimum of 3 days of age * Clinically stable for \> 24 hours while receiving NIPPV or NIV-NAVA Clinical stability will be defined as meeting all the following criteria for a 24 hour period prior to recruitment: 1. differences in maximum and minimum fractions of inspired oxygen (FiO2) of \<20% 2. differences in maximum and minimum MAP \<4 cm H2O 3. no active infection 4. no hypotension 5. no use of cardioactive medications or medical therapy for patent ductus arteriosus. Exclusion Criteria: * Infants with IVH of grade 3 or 4 * Birth weight \< 3rd percentile * Genetic or congenital abnormalities
Where this trial is running
Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Poorva Deshpande — MOUNT SINAI HOSPITAL
- Study coordinator: Poorva Deshpande
- Email: poorva.deshpande@sinaihealth.ca
- Phone: 416-586-4800
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: Sleep, Cerebral Oxygenation, Neurally Adjusted Ventilatory Assist, Non-Invasive Positive Pressure Ventilation, Preterm Neonates, Amplitude integrated electroencephalography