Comparing breathing support methods for preterm infants
Effect of Nasal Continuous Positive Airway Pressure (nCPAP) Versus Non-Invasive Positive Pressure Ventilation (NIPPV) On Diaphragm Electrical Activity (Edi) In Very Low Birth Weight (VLBW) Preterm Infants
NA · Sunnybrook Health Sciences Centre · NCT06295484
This study is testing which breathing support method, CPAP or NIPPV, works better for very low birth weight preterm infants by comparing how their diaphragm functions while using each method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 1 Day to 8 Months |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06295484 on ClinicalTrials.gov |
What this trial studies
This study aims to measure and compare diaphragm electrical activity in very low birth weight preterm infants requiring breathing support through either Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NIPPV). The infants will be assigned to receive each method for two hours in a controlled setting, allowing researchers to monitor their respiratory function and stability. The study will involve routine monitoring of vital signs and will take place in the Neonatal Intensive Care Unit (NICU) at Sunnybrook Health Sciences Centre.
Who should consider this trial
Good fit: Ideal candidates are clinically stable preterm infants with a birth weight of less than 1500 grams who are on nasal CPAP support.
Not a fit: Patients with congenital anomalies, significant neurological deficits, or ongoing treatment for sepsis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve respiratory support strategies for preterm infants, potentially enhancing their recovery and long-term health outcomes.
How similar studies have performed: While the specific comparison of CPAP and NIPPV in this manner may be novel, similar studies have shown varying degrees of success in improving respiratory outcomes in preterm infants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically stable preterm infants (defined as cardiovascular stability with normal blood pressure and heart rate for gestational age and no recent increase in apneic episodes or spells and confirmed by the attending neonatologist) * Birth weight less than 1500 grams * Admitted to the NICU at Sunnybrook Health Sciences Centre on nasal CPAP of 5 to 8 cmH2O support, for at least 48 hours and requiring less than 35% of oxygen Exclusion Criteria: * Congenital anomalies of the gastrointestinal tract * Phrenic nerve damage * Diaphragmatic paralysis * Esophageal perforation * Congenital or acquired neurological deficit (including significant intraventricular hemorrhage greater than Grade II) or neonatal seizure * Significant congenital heart disease (including symptomatic PDA) * Congenital anomalies of the diaphragm * Congenital anomalies of the respiratory tracts (e.g., Congenital Cystic Adenomatoid Malformation 'CCAM') * Ongoing treatment for sepsis * Ongoing treatment for necrotizing enterocolitis (NEC) * Ongoing treatment for lung infections * Narcotic analgesics * Gastric motility agents * Infants on nasal CPAP and requiring more than 35% oxygen * Infants with significant gastric residuals and vomiting * Infants with facial anomalies * Infants with pneumothorax or pneumomediastinum * Infants in the immediate postoperative period
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Maher Shahroor, MD
- Email: maher.shahroor@sunnybrook.ca
- Phone: (416) 480-6100
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: Preterm Birth, Premature Lungs, Respiratory Distress Syndrome in Premature Infant