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Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants

RecruitingNAAges 1 Day - 8 MonthsAllSunnybrook Health Sciences Centre
NCT06295484 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support. The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at

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📋 Eligibility rules (as published)
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
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What it tests

  • Alternating traditional CPAP, NIPPV, and high CPAP
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Where

1 site
Sunnybrook Health Sciences Center
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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